Hair CareNCT07300813
Olistic_2025 for Hair Loss, Hair Growth, and Skin Improvement
A study testing Olistic Next Women in people with Hair Care and Hair Loss, run by Bionos Biotech S.L. at 1 site in Spain.
Trial summary
The goal of this randomized, double-blind, placebo-controlled clinical trial is to find out whether daily oral intake of the nutraceutical Olistic Next Women can reduce hair loss, improve hair growth and quality, and improve signs of skin aging in women with early female-pattern hair loss. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Care, Hair Loss, Female Pattern Hair Loss
- What is being tested?
- Olistic Next Women
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers with initial FPHL.
- Commitment not to use systemic, topical, or oral products with an effect similar to that of the product to be evaluated throughout the study period.
- Do not change the daily routine regarding the use of cosmetic products and eating habits.
- Commitment to comply with all protocol requirements specified in the subject information sheet.
- Availability to comply with all study visits.
Who cannot join
- Allergy or reactivity to some of the components of the product, or a product with similar category than tested one.
- Women who have undergone dermatological treatment for hair loss (PRPs, mesotherapy, etc.) or hair transplant.
- Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate severe seborrheic dermatitis, eczema, cancer, etc.
- Women who present alopecia because of a medical illness (hypothyroidism, anemia, lupus, etc.).
- Relevant cutaneous marks in the experimental areas, which could interfere with the measurements (scars, sunburns, etc.).
- In-use relevant pharmacological or hormonal treatment (eg. valproic acid, carbamazepine, phenytoin).
Show all 20Show fewer
- Women with thyroid alteration (hyper- or hypothyroidism)
- Women who have previously participated in similar studies or who have used anti-hair loss products in the last 3 months.
- Women who are being treated with anticoagulants, antifungals, anxiolytics, amphetamines, retinoids, iron, antithyroid, anticonvulsants, beta blockers and/or ACE inhibitors, minoxidil, finasteride, etc.
- Women who started hormonal treatment (oral or topical contraceptives) in the 6 months prior to the start of the study.
- Women who started taking any drug chronically less than 6 months before the start of the study (they should have a stable situation with the medication over 6 months).
- Modification of the usual diet: low-calorie diet, Atkins diet, etc.
- Pregnant, postpartum (6 months) or breastfeeding women, or who intend to get pregnant during the duration of the study.
- Evidence of systemic diseases (e.g. cardiac disease, psychiatric disease, etc.) or gastrointestinal diseases.
- Serious conditions or illnesses that, in the opinion of the researcher, may be aggravated by participation in the study or that put the development of the study at risk.
- Planned hairstyle changes throughout the study
- Presence of skin diseases or melanomas
- Forecast of change of routine or relevant way of life, during the period of study.
- Other exclusion criteria to be added by the customer.
- Women who have gone dermatological treatment, that they have introduced minoxidil (oral or topical) at least 6 months prior, and antiandrogens (e.g. finasteride) at least 12 months before the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Hair Loss, Hair Growth, and Skin Improvement in Human Volunteers Following a Double-blind, Placebo-controlled, 1:1 Randomized Trial of 'Olistic Next Women'
The goal of this randomized, double-blind, placebo-controlled clinical trial is to find out whether daily oral intake of the nutraceutical Olistic Next Women can reduce hair loss, improve hair growth and quality, and improve signs of skin aging in women with early female-pattern hair loss. One hundred healthy women aged 50-65 years with initial FPHL will be randomly assigned 1:1 to receive either Olistic Next Women or a matching placebo for 6 months. Participants will drink one vial per day for 28 days, rest 2 days each month, and repeat this cycle for the duration of the study.
The main questions are whether Olistic Next Women, compared with placebo, (1) increases hair density and thickness, improves hair growth (anagen/telogen and terminal/vellus ratios), and reduces hair shedding; and (2) improves facial skin parameters related to aging, such as wrinkles, hydration, brightness, elasticity, and firmness. At baseline and at approximately 1, 3, and 6 months, participants will attend clinic visits where hair metrics at two scalp sites will be quantified using HairMetrix imaging; hair shedding will be assessed with standardized comb and wash tests; and hair fiber damage (in a subset) will be evaluated by scanning electron microscopy. Facial skin will be evaluated using 3D wrinkle imaging, Glossymeter, Corneometer, and Cutometer measurements. Participants will also complete the Skindex-29 and a self-perception questionnaire at several time points while maintaining their usual diet and cosmetic routines and avoiding other hair-active treatments or supplements.
Read the detailed description
Hair loss in women and skin aging are multifactorial processes influenced by intrinsic factors (genetics, hormonal changes, chronological aging) and extrinsic factors (UV exposure, environmental stressors, lifestyle). Female pattern hair loss (FPHL) is characterized by gradual thinning and a reduction in hair density, often associated with a decrease in the terminal/vellus hair ratio and changes in the anagen/telogen balance. In parallel, skin aging manifests as wrinkles, loss of elasticity and firmness, reduced hydration, and altered barrier function. Nutraceuticals containing bioactive compounds such as collagen-derived amino acids, plant extracts, vitamins, and minerals have been proposed as a supportive strategy to improve hair and skin parameters from within.
In this double-blind, placebo-controlled, 1:1 randomized cosmetic study, investigators will assess the efficacy of the oral supplement "Olistic Next Women" on hair loss/growth and age-related skin parameters in healthy adult women with initial FPHL. One hundred volunteers aged 50-65 years with early FPHL, confirmed through dermatological assessment, will be enrolled at Bionos Biotech S.L. (Valencia, Spain) after providing written informed consent and meeting predefined inclusion and exclusion criteria. Participants will be randomized to receive either Olistic Next Women or a matching placebo and will consume one vial daily for 28 consecutive days followed by 2 days of rest each month, for a total treatment duration of 6 months. The product and placebo are manufactured in compliance with relevant EU regulations regarding safety, microbiology, allergens, and heavy metals.
Hair and skin assessments will be performed at baseline and during follow-up visits to enable comparisons over time between active and placebo groups. A dermatologist will conduct an initial hair evaluation, followed by standardized measurements at multiple time points. At baseline (D0), month 3 (D90), and month 6 (D180), hair density and growth parameters will be quantified at two scalp sites (behind the ear and at the top of the head, where FPHL is more evident) using HairMetrix® imaging. Parameters will include terminal/vellus ratio, average hairs per follicular unit, hair width, follicle count per cm², hair count per cm², anagen/telogen ratio, and short-term growth rate. Hair shedding will be evaluated at several visits using standardized comb and wash tests after controlled intervals without washing or combing. In a subset of 10 volunteers, hair fiber damage and integrity will be assessed by scanning electron microscopy. Hair volume, general appearance, and overall hair quality will be graded by clinical scoring, and hair shine will be measured using a Glossymeter® probe.
Facial skin will be evaluated at baseline and follow-up visits using non-invasive instrumental methods. Wrinkle area, depth, and volume will be quantified by 3D imaging; skin brightness will be measured with a Glossymeter®; hydration will be assessed using a Corneometer®; and elasticity and firmness will be measured with a Cutometer®. Participants will also complete the Skindex-29 questionnaire to capture the impact of hair and skin status on quality of life, as well as a self-perception questionnaire to document subjective impressions of hair and skin changes over the course of treatment.
Throughout the study, participants will be instructed to maintain their usual diet and basic hygiene habits, to avoid initiating new oral supplements or systemic/topical products with similar effects to the investigational product, and to refrain from intense or invasive cosmetic treatments. Major changes in hairstyle or routine that could interfere with measurements will not be permitted. Compliance with product intake and study instructions will be supported through written guidelines and regular contact with the research team. The primary analysis will compare changes from baseline to post-treatment time points between the Olistic Next Women and placebo groups using appropriate statistical methods for continuous outcomes, with two-sided tests and a significance level of 0.05. The planned sample size of 100 women is based on prior experience and is expected to provide adequate power to detect clinically relevant differences in key hair and skin parameters.
The study will be conducted in accordance with the Declaration of Helsinki, applicable regulations, and local ethics committee approval. All participants will provide written informed consent prior to any study procedures. Data will be coded and handled under Spanish data protection law, and study records will be retained according to regulatory requirements.
- Conditions
- Hair Care, Hair Loss, Female Pattern Hair Loss
- Being tested
- Olistic Next Women, Placebo
- Keywords
- Hair density, Female pattern hair loss, Hair growth, Skin aging, Facial wrinkles, Oral nutraceutical, Skin firmness, Skin elasticity, Dietary supplement, Collagen peptides
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olistic Next WomenOther
Participants will be provided with Olistic Next Women and instructed to drink one vial orally once daily for 6 months (28 consecutive days followed by 2 days of rest each month). Efficacy will be evaluated at baseline and at approximately 1, 3, and 6 months using HairMetrix® imaging (hair density and growth parameters), standardized hair shedding tests, 3D facial wrinkle imaging, Glossymeter® (shine/brightness), Corneometer® (hydration), Cutometer® (firmness, elasticity, fatigue), and patient-reported questionnaires (Skindex-29 and a self-perception questionnaire). Product is supplied in individual single-dose vials and stored according to the manufacturer's instructions. All procedures occur at Bionos Biotech S.L. facilities.
PlaceboOther
Participants will be provided with a matching placebo and instructed to drink one vial orally once daily for 6 months (28 consecutive days followed by 2 days of rest each month). Efficacy will be evaluated at baseline and at approximately 1, 3, and 6 months using HairMetrix® imaging (hair density and growth parameters), standardized hair shedding tests, 3D facial wrinkle imaging, Glossymeter® (shine/brightness), Corneometer® (hydration), Cutometer® (firmness, elasticity, fatigue), and patient-reported questionnaires (Skindex-29 and a self-perception questionnaire). Product is supplied in individual single-dose vials and stored according to the manufacturer's instructions. All procedures occur at Bionos Biotech S.L. facilities.
| Study group | Role | What they receive |
|---|---|---|
| Olistic Next Women | Experimental | This group will be provided with the product Olistic Next Women. Receives: Other: Olistic Next Women |
| Placebo | Placebo comparator | This group will be provided with placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hair density (hair count per cm²) measured by HairMetrix®.
Change in hair density, expressed as hair count per cm², from baseline to follow-up visits. Hair density is assessed using standardized HairMetrix® imaging at predefined scalp sites. To ensure measurement accuracy and reproducibility, all assessments are performed 2 days after standardized scalp clipping, allowing sufficient hair regrowth for reliable detection and analysis.
Measured: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Secondary outcomes (18)
Change from baseline in terminal/vellus hair ratio (unitless) measured by HairMetrix®
Change in the terminal-to-vellus hair ratio from baseline to follow-up visits, assessed using standardized HairMetrix® imaging at predefined scalp sites. Measurements are performed 2 days after standardized scalp clipping at each time point to ensure consistent hair length and reliable classification of terminal and vellus hairs.
Measured: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change from baseline in mean hair shaft width (µm) measured by HairMetrix®
Change in mean hair shaft width from baseline to follow-up visits at the predefined scalp site(s). To ensure measurement accuracy and reproducibility, all assessments are performed 2 days after standardized scalp clipping, allowing sufficient hair regrowth for reliable detection and analysis.
Measured: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change from baseline in follicle count per cm² measured by HairMetrix®
Change in follicle count per cm² from baseline to follow-up visits at the predefined scalp site(s). To ensure measurement accuracy and reproducibility, all assessments are performed 2 days after standardized scalp clipping, allowing sufficient hair regrowth for reliable detection and analysis.
Measured: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change from baseline in anagen/telogen ratio (unitless) measured by HairMetrix®
Change in anagen/telogen ratio from baseline to follow-up visits at the predefined scalp site(s). To ensure measurement accuracy and reproducibility, all assessments are performed 2 days after standardized scalp clipping, allowing sufficient hair regrowth for reliable detection and analysis.
Measured: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change from baseline in short-term hair growth rate (mm/day) measured by HairMetrix®
Change in short-term growth rate from baseline to follow-up visits at the predefined scalp site(s). To ensure measurement accuracy and reproducibility, all assessments are performed 2 days after standardized scalp clipping, allowing sufficient hair regrowth for reliable detection and analysis.
Measured: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change from baseline in wrinkle volume (mm³) measured by 3D imaging.
Change in wrinkle volume, expressed in mm³, from baseline to follow-up visits, assessed using standardized VISIA-PRIMOS® 5 three-dimensional facial imaging at predefined facial regions. Image acquisition and analysis are performed under controlled conditions to ensure reproducibility across time points.
Measured: Baseline and ~1, 3, 6 months.
Change from baseline in wrinkle area (mm³) measured by 3D imaging
Change in wrinkle area, expressed in mm³, from baseline to follow-up visits, assessed using standardized VISIA-PRIMOS® 5 three-dimensional facial imaging at predefined facial regions. Image acquisition and analysis are performed under controlled conditions to ensure reproducibility across time points.
Measured: Baseline and ~1, 3, 6 months.
Change from baseline in depth volume (mm³) measured by 3D imaging
Change in wrinkle depth, expressed in mm³, from baseline to follow-up visits, assessed using standardized VISIA-PRIMOS® 5 three-dimensional facial imaging at predefined facial regions. Image acquisition and analysis are performed under controlled conditions to ensure reproducibility across time points.
Measured: Baseline and ~1, 3, 6 months.
Change from baseline in skin hydration (Corneometer units, a.u.)
Change in Corneometer® readings (arbitrary units) from baseline to follow-up visits at the predefined facial region(s).
Measured: Baseline and ~1, 3, 6 months.
Change from baseline in skin gloss/brightness (Gloss units)
Change in Glossymeter® readings from baseline to follow-up visits at the predefined facial region(s).
Measured: Baseline and ~1, 3, 6 months.
Change from baseline in skin elasticity (Cutometer® R2, unitless)
Change in skin elasticity, expressed by the R2 parameter (mm), from baseline to follow-up visits. Measurements are performed using a Cutometer® at predefined facial regions under standardized conditions to ensure reproducibility across all time points.
Measured: Baseline and ~1, 3, 6 months.
Change from baseline in skin firmness (Cutometer® R0, mm)
Change in skin firmness, expressed by the R0 parameter (mm), from baseline to follow-up visits. Measurements are performed using a Cutometer® at predefined facial regions under standardized conditions to ensure reproducibility across all time points.
Measured: Baseline and ~1, 3, 6 months.
Change from baseline in Skindex-29 overall score (0-100; higher = worse quality of life)
Change in the total score of the Skindex-29 questionnaire from baseline to follow-up visits. The Skindex-29 is a 29-item, patient-reported questionnaire assessing the impact of alopecia and scalp-related symptoms on quality of life (e.g., pain, itching, burning, irritation, emotional distress, social functioning, daily activities, and sexual life). Each item is scored on a 5-point Likert scale ranging from 0 (Never) to 4 (All the time). The total score ranges from 0 to 116, with higher scores indicating worse quality of life.
Measured: before treatment, after 1-, 3 and 6 months treatment.
Change from baseline in Self-Perception Questionnaire total score
Change in participants' self-assessment of product performance and cosmetic acceptability from baseline to follow-up visits. Each parameter is rated on a 5-point agreement scale ranging from 1 (Agree), 2 (Partially agree), 3 (Slightly agree), 4 (Partially disagree) to 5 (Disagree).
For data analysis, an overall acceptance score is calculated as the percentage of positive evaluations (responses of Agree, Partially agree, or Slightly agree) across all assessed parameters. An overall acceptance value ≥ 80% is considered indicative of high consumer acceptance.
Measured: before treatment, after 1-, 3 and 6 months treatment.
Change from baseline in hair volume, general appearance, and hair quality assessed by clinical scoring
Change in hair volume, general appearance, and overall hair quality from baseline to follow-up visits, assessed using standardized clinical scoring. Evaluations are performed at predefined time points based on standardized photographs. Images are independently analyzed by external dermatologists blinded to treatment allocation to ensure objective assessment.
Measured: Baseline and ~1, 3, 6 months.
Change from baseline in hair fiber integrity and thickness assessed by scanning electron microscopy
Change in hair fiber integrity and thickness from baseline to follow-up visits, assessed using scanning electron microscopy (SEM) in a subset of 10 volunteers. SEM imaging is used to evaluate hair fiber surface morphology and structural damage, allowing qualitative and semi-quantitative assessment of fiber integrity and thickness over time.
Measured: Baseline and ~1, 3, 6 months.
Change from baseline in number of fallen hairs after combing assessed by comb test
Change in the number of fallen hairs collected after standardized combing from baseline to follow-up visits, assessed using a comb test procedure. This outcome is used to evaluate changes in hair shedding and to assess a potential strengthening effect over time.
Measured: Baseline and ~1, 3, 6 months.
Change from baseline in number of fallen hairs after washing assessed by wash test
Change in the number of fallen hairs collected after a standardized washing procedure from baseline to follow-up visits, assessed using a wash test procedure. This outcome is used to evaluate changes in hair shedding and to assess a potential strengthening effect over time.
Measured: Baseline and ~1, 3, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start20 Oct 2025
- Primary completion4 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive either Olistic Next Women or a matching placebo and remain in the same group for the full 6-month treatment period (parallel two-arm design, no crossover).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionos Biotech S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adela Serrano Gimeno, PhD, Principal investigator, Bionos Biotech S.L. , LabAnalysis Life Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300813
- Sponsor's protocol ID
- Olistic_2025
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hair Loss, Hair Growth, and Skin Improvement in Human Volunteers Following a Double-blind, Placebo-controlled, 1:1 Randomized Trial of 'Olistic Next Women'
- ClinicalTrials.gov ID
- NCT07300813
- Acronym / sponsor ID
- Olistic_2025
- Conditions
- Hair Care, Hair Loss, Female Pattern Hair Loss
- Keywords
- Hair density, Female pattern hair loss, Hair growth, Skin aging, Facial wrinkles, Oral nutraceutical, Skin firmness, Skin elasticity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bionos Biotech S.L.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 4 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized, double-blind, placebo-controlled clinical trial is to find out whether daily oral intake of the nutraceutical Olistic Next Women can reduce hair loss, improve hair growth and quality, and improve signs of skin aging in women with early female-pattern hair loss. One hundred healthy women aged 50-65 years with initial FPHL will be randomly assigned 1:1 to receive either Olistic Next Women or a matching placebo for 6 months. Participants will drink one vial per day for 28 days, rest 2 days each month, and repeat this cycle for the duration of the study.
The main questions are whether Olistic Next Women, compared with placebo, (1) increases hair density and thickness, improves hair growth (anagen/telogen and terminal/vellus ratios), and reduces hair shedding; and (2) improves facial skin parameters related to aging, such as wrinkles, hydration, brightness, elasticity, and firmness. At baseline and at approximately 1, 3, and 6 months, participants will attend clinic visits where hair metrics at two scalp sites will be quantified using HairMetrix imaging; hair shedding will be assessed with standardized comb and wash tests; and hair fiber damage (in a subset) will be evaluated by scanning electron microscopy. Facial skin will be evaluated using 3D wrinkle imaging, Glossymeter, Corneometer, and Cutometer measurements. Participants will also complete the Skindex-29 and a self-perception questionnaire at several time points while maintaining their usual diet and cosmetic routines and avoiding other hair-active treatments or supplements.
Detailed description
Hair loss in women and skin aging are multifactorial processes influenced by intrinsic factors (genetics, hormonal changes, chronological aging) and extrinsic factors (UV exposure, environmental stressors, lifestyle). Female pattern hair loss (FPHL) is characterized by gradual thinning and a reduction in hair density, often associated with a decrease in the terminal/vellus hair ratio and changes in the anagen/telogen balance. In parallel, skin aging manifests as wrinkles, loss of elasticity and firmness, reduced hydration, and altered barrier function. Nutraceuticals containing bioactive compounds such as collagen-derived amino acids, plant extracts, vitamins, and minerals have been proposed as a supportive strategy to improve hair and skin parameters from within.
In this double-blind, placebo-controlled, 1:1 randomized cosmetic study, investigators will assess the efficacy of the oral supplement "Olistic Next Women" on hair loss/growth and age-related skin parameters in healthy adult women with initial FPHL. One hundred volunteers aged 50-65 years with early FPHL, confirmed through dermatological assessment, will be enrolled at Bionos Biotech S.L. (Valencia, Spain) after providing written informed consent and meeting predefined inclusion and exclusion criteria. Participants will be randomized to receive either Olistic Next Women or a matching placebo and will consume one vial daily for 28 consecutive days followed by 2 days of rest each month, for a total treatment duration of 6 months. The product and placebo are manufactured in compliance with relevant EU regulations regarding safety, microbiology, allergens, and heavy metals.
Hair and skin assessments will be performed at baseline and during follow-up visits to enable comparisons over time between active and placebo groups. A dermatologist will conduct an initial hair evaluation, followed by standardized measurements at multiple time points. At baseline (D0), month 3 (D90), and month 6 (D180), hair density and growth parameters will be quantified at two scalp sites (behind the ear and at the top of the head, where FPHL is more evident) using HairMetrix® imaging. Parameters will include terminal/vellus ratio, average hairs per follicular unit, hair width, follicle count per cm², hair count per cm², anagen/telogen ratio, and short-term growth rate. Hair shedding will be evaluated at several visits using standardized comb and wash tests after controlled intervals without washing or combing. In a subset of 10 volunteers, hair fiber damage and integrity will be assessed by scanning electron microscopy. Hair volume, general appearance, and overall hair quality will be graded by clinical scoring, and hair shine will be measured using a Glossymeter® probe.
Facial skin will be evaluated at baseline and follow-up visits using non-invasive instrumental methods. Wrinkle area, depth, and volume will be quantified by 3D imaging; skin brightness will be measured with a Glossymeter®; hydration will be assessed using a Corneometer®; and elasticity and firmness will be measured with a Cutometer®. Participants will also complete the Skindex-29 questionnaire to capture the impact of hair and skin status on quality of life, as well as a self-perception questionnaire to document subjective impressions of hair and skin changes over the course of treatment.
Throughout the study, participants will be instructed to maintain their usual diet and basic hygiene habits, to avoid initiating new oral supplements or systemic/topical products with similar effects to the investigational product, and to refrain from intense or invasive cosmetic treatments. Major changes in hairstyle or routine that could interfere with measurements will not be permitted. Compliance with product intake and study instructions will be supported through written guidelines and regular contact with the research team. The primary analysis will compare changes from baseline to post-treatment time points between the Olistic Next Women and placebo groups using appropriate statistical methods for continuous outcomes, with two-sided tests and a significance level of 0.05. The planned sample size of 100 women is based on prior experience and is expected to provide adequate power to detect clinically relevant differences in key hair and skin parameters.
The study will be conducted in accordance with the Declaration of Helsinki, applicable regulations, and local ethics committee approval. All participants will provide written informed consent prior to any study procedures. Data will be coded and handled under Spanish data protection law, and study records will be retained according to regulatory requirements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive either Olistic Next Women or a matching placebo and remain in the same group for the full 6-month treatment period (parallel two-arm design, no crossover).
| Arm | Type | Receives |
|---|---|---|
| Olistic Next Women | Experimental | Other: Olistic Next WomenThis group will be provided with the product Olistic Next Women. |
| Placebo | Placebo comparator | Other: PlaceboThis group will be provided with placebo. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers with initial FPHL.
- Commitment not to use systemic, topical, or oral products with an effect similar to that of the product to be evaluated throughout the study period.
- Do not change the daily routine regarding the use of cosmetic products and eating habits.
- Commitment to comply with all protocol requirements specified in the subject information sheet.
- Availability to comply with all study visits.
Key exclusion criteria (20 listed)
- Allergy or reactivity to some of the components of the product, or a product with similar category than tested one.
- Women who have undergone dermatological treatment for hair loss (PRPs, mesotherapy, etc.) or hair transplant.
- Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate severe seborrheic dermatitis, eczema, cancer, etc.
- Women who present alopecia because of a medical illness (hypothyroidism, anemia, lupus, etc.).
- Relevant cutaneous marks in the experimental areas, which could interfere with the measurements (scars, sunburns, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olistic Next WomenParticipants will be provided with Olistic Next Women and instructed to drink one vial orally once daily for 6 months (28 consecutive days followed by 2 days of rest each month). Efficacy will be evaluated at baseline and at approximately 1, 3, and 6 months using HairMetrix® imaging (hair density and growth parameters), standardized hair shedding tests, 3D facial wrinkle imaging, Glossymeter® (shine/brightness), Corneometer® (hydration), Cutometer® (firmness, elasticity, fatigue), and patient-reported questionnaires (Skindex-29 and a self-perception questionnaire). Product is supplied in individual single-dose vials and stored according to the manufacturer's instructions. All procedures occur at Bionos Biotech S.L. facilities. | Other | Olistic Next Women |
| PlaceboParticipants will be provided with a matching placebo and instructed to drink one vial orally once daily for 6 months (28 consecutive days followed by 2 days of rest each month). Efficacy will be evaluated at baseline and at approximately 1, 3, and 6 months using HairMetrix® imaging (hair density and growth parameters), standardized hair shedding tests, 3D facial wrinkle imaging, Glossymeter® (shine/brightness), Corneometer® (hydration), Cutometer® (firmness, elasticity, fatigue), and patient-reported questionnaires (Skindex-29 and a self-perception questionnaire). Product is supplied in individual single-dose vials and stored according to the manufacturer's instructions. All procedures occur at Bionos Biotech S.L. facilities. | Other | Placebo |
Primary outcome
Change from baseline in hair density (hair count per cm²) measured by HairMetrix®.
Time frame: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change in hair density, expressed as hair count per cm², from baseline to follow-up visits. Hair density is assessed using standardized HairMetrix® imaging at predefined scalp sites. To ensure measurement accuracy and reproducibility, all assessments are performed 2 days after standardized scalp clipping, allowing sufficient hair regrowth for reliable detection and analysis.
18 secondary outcomes
Change from baseline in terminal/vellus hair ratio (unitless) measured by HairMetrix®
Time frame: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change from baseline in mean hair shaft width (µm) measured by HairMetrix®
Time frame: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change from baseline in follicle count per cm² measured by HairMetrix®
Time frame: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change from baseline in anagen/telogen ratio (unitless) measured by HairMetrix®
Time frame: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change from baseline in short-term hair growth rate (mm/day) measured by HairMetrix®
Time frame: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).
Change from baseline in wrinkle volume (mm³) measured by 3D imaging.
Time frame: Baseline and ~1, 3, 6 months.
Change from baseline in wrinkle area (mm³) measured by 3D imaging
Time frame: Baseline and ~1, 3, 6 months.
Change from baseline in depth volume (mm³) measured by 3D imaging
Time frame: Baseline and ~1, 3, 6 months.
Change from baseline in skin hydration (Corneometer units, a.u.)
Time frame: Baseline and ~1, 3, 6 months.
Change from baseline in skin gloss/brightness (Gloss units)
Time frame: Baseline and ~1, 3, 6 months.
Change from baseline in skin elasticity (Cutometer® R2, unitless)
Time frame: Baseline and ~1, 3, 6 months.
Change from baseline in skin firmness (Cutometer® R0, mm)
Time frame: Baseline and ~1, 3, 6 months.
Change from baseline in Skindex-29 overall score (0-100; higher = worse quality of life)
Time frame: before treatment, after 1-, 3 and 6 months treatment.
Change from baseline in Self-Perception Questionnaire total score
Time frame: before treatment, after 1-, 3 and 6 months treatment.
Change from baseline in hair volume, general appearance, and hair quality assessed by clinical scoring
Time frame: Baseline and ~1, 3, 6 months.
Change from baseline in hair fiber integrity and thickness assessed by scanning electron microscopy
Time frame: Baseline and ~1, 3, 6 months.
Change from baseline in number of fallen hairs after combing assessed by comb test
Time frame: Baseline and ~1, 3, 6 months.
Change from baseline in number of fallen hairs after washing assessed by wash test
Time frame: Baseline and ~1, 3, 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adela Serrano Gimeno, PhD principal investigator
Bionos Biotech S.L. , LabAnalysis Life Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olistic Next Women in people with Hair Care and Hair Loss, run by Bionos Biotech S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hair density (hair count per cm²) measured by HairMetrix®. (time frame: Baseline ( 2 days after clipping) 3 months (2 days after clipping), 6 months (2 days after clipping).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.