SkinSkinMeterNCT07343544
Clinical Trial to Assess the Efficacy and Safety of a Cosmetic Product in Individuals Showing Signs of Cutaneous Aging.
A study testing Active cream in people with Skin and Skin Ageing, run by AB Biotics, SA.
Trial summary
This clinical study investigates the effects and safety of a topical cosmetic product containing postbiotics (Bifida ferment extract and Pediococcus ferment extract) in women aged 35-60 with visible signs of skin aging. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin, Skin Ageing, Fine Lines
- What is being tested?
- Active cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to May 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants.
- Age between 35 and 60 years.
- All skin types (combination, oily, dry, and/or normal).
- Skin condition: 50% sensitive skin and 50% normal skin.
- Visible signs of facial skin aging (mild/moderate wrinkles and/or pigmentation spots).
- Willingness to participate voluntarily and provide written informed consent.
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- Ability to understand the study objectives and procedures.
- Good general health (physical and mental).
- Availability to attend all scheduled visits at the research center.
- Discontinuation of anti-aging products on the experimental area (face) at least 7 days prior to study start.
- Commitment not to change facial hygiene routines during the study.
Who cannot join
- Pregnant or breastfeeding women.
- History of allergy to cosmetic products and/or dietary supplements.
- Known allergy or hypersensitivity to any component of the product.
- History or current diagnosis of cancer.
- Active skin diseases or infections in the experimental area.
- Recent or planned surgical or aesthetic interventions in the experimental area Medical-aesthetic treatments on the face within the last 6 months (e.g., botulinum toxin, hyaluronic acid, laser, radiofrequency, HIFU, deep chemical peels, microneedling with actives).
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- Relevant dermatological conditions in the experimental area (eczema, psoriasis, allergic/contact dermatitis, etc.).
- Use of topical or systemic medications affecting the skin (retinoids, antibiotics, corticosteroids) within the last 3 months.
- Current or planned use of supplements that may affect skin health (collagen, antioxidant vitamins A/C/E, zinc, omega-3, oral probiotics/prebiotics).
- Systemic diseases such as autoimmune disorders (rheumatoid arthritis, lupus, multiple sclerosis), chronic viral infections (HIV, hepatitis B/C), or severe metabolic diseases.
- Use of any product other than the study product on the experimental area during the study.
- Planned significant changes in health habits during the study (diet, physical activity, structured exercise programs).
- Recent or planned changes in hormonal contraceptives.
- Sun or UVA exposure during the study.
- Participation in another clinical study involving the same experimental area
- Application of any product on the experimental area on the day of study initiation.
- Any medical condition, at the investigator's discretion, that may interfere with protocol adherence or participant safety.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Estudio clínico Para Evaluar Los Efectos y la Seguridad de un Producto cosmético en Sujetos Con Signos de Envejecimiento cutáneo.
This clinical study investigates the effects and safety of a topical cosmetic product containing postbiotics (Bifida ferment extract and Pediococcus ferment extract) in women aged 35-60 with visible signs of skin aging.
The study is a 3-month, single-center, intra-subject controlled trial involving 45 Caucasian women with sensitive or normal skin. Participants will apply 1 ml of the product twice daily. Clinical evaluations will be conducted at baseline and at 1 month, 2 months, and 3 months, using validated dermatological scales and non-invasive instruments (AEVA3D, Mexameter®, MoistureMap®, Cutometer®, Tewameter®, Clarius®, Glossymeter®).
Safety will be assessed through systematic monitoring of adverse events, with serious adverse events expected to remain below 1%. Subjective perception will be evaluated via structured questionnaires.
Read the detailed description
This clinical study is designed to evaluate the effects and safety of a topical cosmetic product formulated with postbiotic ingredients in adult women presenting visible signs of skin aging. The product contains Bifida ferment extract and Pediococcus ferment extract, selected for their scientifically supported properties in enhancing skin barrier function, reducing oxidative stress, and improving overall skin appearance.
The study is a prospective, single-center, intra-subject controlled clinical trial with a total duration of three months. Forty-five Caucasian women aged between 35 and 60 years will be enrolled. Participants must present mild to moderate facial wrinkles and/or pigmentation spots and will be evenly distributed between sensitive and normal skin types. Inclusion and exclusion criteria are clearly defined to ensure participant safety and data reliability.
Participants will apply 1 ml of the cosmetic product twice daily (morning and evening) to clean, dry facial skin. The study includes four scheduled visits: pre-selection, baseline (T0), (T1), 1 month (T2), 2 months (T3), and 3 months (T4). During these visits, clinical assessments will be conducted using validated dermatological scales (Skin Aging Atlas and Glogau scale) and non-invasive instrumental evaluations.
Instrumental assessments include AEVA3D, Mexameter®, MoistureMap®, Cutometer®, Tewameter®, Clarius®, Glossymeter®.
Photographic documentation will be performed using Visiofaceae, capturing standardized facial images at each visit.
Subjective perception will be evaluated through structured questionnaires administered at T1, T2, T3, and additionally at day 7. These questionnaires assess product appreciation, organoleptic characteristics, absorption, residue, and perceived effects on skin condition.
Safety monitoring includes systematic documentation of all adverse events (AEs). The expected incidence of SAEs related to the product is below 1%. All safety data will be recorded in the Case Report Form (CRF) and analyzed according to Good Clinical Practice (GCP) guidelines. Participants will be compensated for travel and related expenses.
Statistical analysis will be conducted using RStudio software. The study is powered to detect significant changes in skin aging parameters, with a sample size of 45 participants calculated to achieve 80% statistical power. Analysis will include descriptive statistics, repeated measures ANOVA, and mixed model repeated measures (MMRM) to evaluate treatment effects over time.
This study aims to provide robust clinical evidence supporting the efficacy and safety of a novel cosmetic formulation based on postbiotic technology, contributing to the development of innovative anti-aging skincare solutions.
- Conditions
- Skin, Skin Ageing, Fine Lines, Face Aging/Photo Aging of Moderate Grade, Face Skin Photoaging
- Being tested
- Active cream
- Keywords
- Face Skin, Postbiotics, Skin, Skin ageing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active creamOther
Active facial cream with postbiotics.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Other | Open Label Active Product Receives: Other: Active cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle Reduction
Changes in visible signs of skin aging (wrinkles and spots) after 3 months of continuous application. Assess the evolution of wrinkles using AEVA3D-HE2.
Measured: From baseline to the end of treatment at 3 months
Secondary outcomes (9)
Spot Depigmentation
Evaluate the improvement in facial pigmentation using a clinical scale adapted from the Glogau Scale.
Measured: From baseline until the end of treatment at 3 months
Facial Contour Evolution
Assess the evolution of contour after 1, 2, and 3 months using AEVA3D-HE2.
Measured: From baseline until the end of treatment at 3 months
Spot Evolution
Assess the evolution of facial spots after 1, 2, and 3 months using Mexameter® MX 18.
Measured: From baseline until the end of treatment at 3 months
Skin Hydration
Determine facial hydration after 1, 2, and 3 months using MoistureMap® MM200.
Measured: From baseline until the end of treatment at 3 months
Firmness & Elasticity
Determine facial firmness and elasticity after 1, 2, and 3 months using Cutometer® MPA 580.
Measured: From baseline until the end of treatment at 3 months
Barrier Function
Determine facial barrier function after 1, 2, and 3 months using Tewameter® TM 300.
Measured: From baseline until the end of treatment at 3 months
Dermal Thickness
Changes in dermal thickness using Clarius® ultrasound.
Measured: From baseline until the end of treatment at 3 months
Skin Radiance
Changes in facial radiance using Skin-Glossymeter® GL200.
Measured: From baseline until the end of treatment at 3 months
Self-perceived improvement
Changes in self-perceived improvement assessed with subjective question.
Measured: From baseline until the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SkinStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Responsible party
- Sponsor
- Investigators
- Ester Moreno Artero, PhD, Principal investigator, Dr. Goya Análisis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343544
- Sponsor's protocol ID
- AB BIOTICS_2501_COS /SkinMeter
- Acronym
- SkinMeter
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sponsor will evaluated IPD sharing upon request
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio clínico Para Evaluar Los Efectos y la Seguridad de un Producto cosmético en Sujetos Con Signos de Envejecimiento cutáneo.
- ClinicalTrials.gov ID
- NCT07343544
- Acronym / sponsor ID
- SkinMeter / AB BIOTICS_2501_COS /SkinMeter
- Conditions
- Skin, Skin Ageing, Fine Lines, Face Aging/Photo Aging of Moderate Grade, Face Skin Photoaging
- Keywords
- Face Skin, Postbiotics, Skin, Skin ageing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 15 Jan 2026 (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.
This clinical study investigates the effects and safety of a topical cosmetic product containing postbiotics (Bifida ferment extract and Pediococcus ferment extract) in women aged 35-60 with visible signs of skin aging.
The study is a 3-month, single-center, intra-subject controlled trial involving 45 Caucasian women with sensitive or normal skin. Participants will apply 1 ml of the product twice daily. Clinical evaluations will be conducted at baseline and at 1 month, 2 months, and 3 months, using validated dermatological scales and non-invasive instruments (AEVA3D, Mexameter®, MoistureMap®, Cutometer®, Tewameter®, Clarius®, Glossymeter®).
Safety will be assessed through systematic monitoring of adverse events, with serious adverse events expected to remain below 1%. Subjective perception will be evaluated via structured questionnaires.
Detailed description
This clinical study is designed to evaluate the effects and safety of a topical cosmetic product formulated with postbiotic ingredients in adult women presenting visible signs of skin aging. The product contains Bifida ferment extract and Pediococcus ferment extract, selected for their scientifically supported properties in enhancing skin barrier function, reducing oxidative stress, and improving overall skin appearance.
The study is a prospective, single-center, intra-subject controlled clinical trial with a total duration of three months. Forty-five Caucasian women aged between 35 and 60 years will be enrolled. Participants must present mild to moderate facial wrinkles and/or pigmentation spots and will be evenly distributed between sensitive and normal skin types. Inclusion and exclusion criteria are clearly defined to ensure participant safety and data reliability.
Participants will apply 1 ml of the cosmetic product twice daily (morning and evening) to clean, dry facial skin. The study includes four scheduled visits: pre-selection, baseline (T0), (T1), 1 month (T2), 2 months (T3), and 3 months (T4). During these visits, clinical assessments will be conducted using validated dermatological scales (Skin Aging Atlas and Glogau scale) and non-invasive instrumental evaluations.
Instrumental assessments include AEVA3D, Mexameter®, MoistureMap®, Cutometer®, Tewameter®, Clarius®, Glossymeter®.
Photographic documentation will be performed using Visiofaceae, capturing standardized facial images at each visit.
Subjective perception will be evaluated through structured questionnaires administered at T1, T2, T3, and additionally at day 7. These questionnaires assess product appreciation, organoleptic characteristics, absorption, residue, and perceived effects on skin condition.
Safety monitoring includes systematic documentation of all adverse events (AEs). The expected incidence of SAEs related to the product is below 1%. All safety data will be recorded in the Case Report Form (CRF) and analyzed according to Good Clinical Practice (GCP) guidelines. Participants will be compensated for travel and related expenses.
Statistical analysis will be conducted using RStudio software. The study is powered to detect significant changes in skin aging parameters, with a sample size of 45 participants calculated to achieve 80% statistical power. Analysis will include descriptive statistics, repeated measures ANOVA, and mixed model repeated measures (MMRM) to evaluate treatment effects over time.
This study aims to provide robust clinical evidence supporting the efficacy and safety of a novel cosmetic formulation based on postbiotic technology, contributing to the development of innovative anti-aging skincare solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Other | Other: Active creamOpen Label Active Product |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female participants.
- Age between 35 and 60 years.
- All skin types (combination, oily, dry, and/or normal).
- Skin condition: 50% sensitive skin and 50% normal skin.
- Visible signs of facial skin aging (mild/moderate wrinkles and/or pigmentation spots).
Key exclusion criteria (17 listed)
- Pregnant or breastfeeding women.
- History of allergy to cosmetic products and/or dietary supplements.
- Known allergy or hypersensitivity to any component of the product.
- History or current diagnosis of cancer.
- Active skin diseases or infections in the experimental area.
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 |
|---|---|---|
| Active creamActive facial cream with postbiotics. | Other | Study Arm |
Primary outcome
Wrinkle Reduction
Time frame: From baseline to the end of treatment at 3 months
Changes in visible signs of skin aging (wrinkles and spots) after 3 months of continuous application. Assess the evolution of wrinkles using AEVA3D-HE2.
9 secondary outcomes
Spot Depigmentation
Time frame: From baseline until the end of treatment at 3 months
Facial Contour Evolution
Time frame: From baseline until the end of treatment at 3 months
Spot Evolution
Time frame: From baseline until the end of treatment at 3 months
Skin Hydration
Time frame: From baseline until the end of treatment at 3 months
Firmness & Elasticity
Time frame: From baseline until the end of treatment at 3 months
Barrier Function
Time frame: From baseline until the end of treatment at 3 months
Dermal Thickness
Time frame: From baseline until the end of treatment at 3 months
Skin Radiance
Time frame: From baseline until the end of treatment at 3 months
Self-perceived improvement
Time frame: From baseline until the end of treatment at 3 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 15 Jan 2026.
- Individual participant dataSharing planned: No. Sponsor will evaluated IPD sharing upon request
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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.
Ester Moreno Artero, PhD principal investigator
Dr. Goya Análisis
Questions about this trial
What is this clinical trial studying?
A study testing Active cream in people with Skin and Skin Ageing, run by AB Biotics, SA.
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 11 inclusion and 17 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: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Jordi Espadaler, PhD (+34 659055442, espadaler@ab-biotics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrinkle Reduction (time frame: From baseline to the end of treatment at 3 months). 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 15 Jan 2026.