Androgenetic AlopeciaNCT06841458
Six-Month Single-Blind, Placebo-Controlled Study of a Dietary Supplement Supplement on Hair Growth in 45 Volunteers
A study testing Oral Supplement in people with Androgenetic Alopecia, run by Industrial Farmacéutica Cantabria, S.A. at 2 sites in Spain.
Trial summary
This clinical study is designed to evaluate the efficacy and safety of a dietary supplement CL-P24113a for the management of androgenetic alopecia (AGA) in male subjects aged 18 to 45 years who suffer from alopecia with low hair density, classified as mild to moderate (Hamilton-Norwood stages II, III, and IV). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Oral Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesSpain
- Study dates
- 7 Oct 2024to 1 Jun 2025
- 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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Written consent for LOPD compliance.
- Written informed consent for study DC.506.36.117.
- Gender: Male.
- Age: Between 18 and 45 years.
- Diagnosis of alopecia with low hair density, classified as mild to moderate (stages II, III, and IV on the Hamilton-Norwood scale).
- Willingness to have a 1-2 cm² area shaved throughout the study period.
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- Last participation in a clinical study on hair health must have ended at least six months before the start of this study.
- 30-day washout period without specific hair treatments (using a neutral shampoo).
- No use of any other topical or oral hair treatments in the target area during the study period; if necessary, consultation with the principal investigator is required to evaluate continued study participation.
Who cannot join
- Individuals with gastrointestinal diseases (e.g., diabetes, gastritis, Crohn's disease, celiac disease, ulcers, intolerances, etc.).
- Individuals with other physiological disorders (e.g., diabetes, hypertension, dyslipidemia) and/or gallstones.
- Individuals undergoing medical treatment in the weeks prior to the study that may interfere with study assessments (as determined by the investigator), particularly those who are currently taking or have taken 5α-reductase inhibitors (Finasteride, Dutasteride, Minoxidil, etc.) within the last three months.
- Individuals who have undergone hair restoration treatments at any point in their lives, including hair transplants, mesotherapy, or platelet-rich plasma (PRP) therapy.
- Individuals following an atypical diet or planning to change their dietary routine during the study period.
- Individuals enrolled in another clinical study with similar characteristics (as determined by the investigator) during the study period.
- Individuals who are unable to fully understand the informed consent document or adhere to the study protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
DermaClaim
Valencia, Valencia, 46020
DermaClaim, +34961874582, dermaclaim@dermaclaim.com
- Recruiting
DermaClaim
Valencia
DermaClaim, 961874582, dermaclaim@dermaclaim.com
About this study
Official title: Instrumental, Single-Blind, Placebo-Controlled Study Evaluating the Efficacy of a Dietary Supplement on Hair Growth Over 6 Months in 45 Volunteers
This clinical study is designed to evaluate the efficacy and safety of a dietary supplement CL-P24113a for the management of androgenetic alopecia (AGA) in male subjects aged 18 to 45 years who suffer from alopecia with low hair density, classified as mild to moderate (Hamilton-Norwood stages II, III, and IV). The product is a formulation based on a blend of botanical ingredients and other well-established compounds, including Pumpkin Seed Oil (Curcubita pepo), Saw Palmetto Oil (Serenoa repens), L-Cystine, Prunus africana Bark Extract (Pygeum africanum), Horsetail Extract (Equisetum arvense), Olive Leaf Extract, among other excipients. These components have a well-documented history of safe use in both topical and oral applications with supporting safety information from international bodies such as EFSA. In this instrumental, single-blind, placebo-controlled study, 45 volunteers will be divided into two groups, with 30 subjects receiving the supplement and 15 subjects receiving a placebo. All participants will ingest one capsule per day, preferably in the morning with a glass of water, over a 6-month treatment period. Prior to study initiation, subjects must complete a 30-day washout period using a neutral shampoo and agree not to apply any other topical or oral hair treatments in the target area throughout the study. The study will evaluate efficacy through both instrumental and subjective assessments. Instrumental evaluations will be conducted at 3 and 6 months using the TrichoScan HD Professional 4.0 system to measure hair growth parameters such as total hair count, hair density per cm², proportion of hairs, terminal hair count and density, proportion of terminal hairs, as well as the percentages of anagen and telogen hairs. Additionally, measurements of hair thickness including hair mass per cm², median and mean hair thickness in micrometers, overall scalp hair density, and median hair length will be recorded. Subjective evaluations will be performed via questionnaires administered at 1.5, 3, 4.5, and 6 months to capture participants' perceptions regarding hair growth and hair loss. The study is overseen by Principal Investigator at Dermaclaim Lab S.L. Regulatory compliance will be ensured by obtaining written informed consent for both study participation and data protection, and all subjects will be thoroughly briefed on study requirements and potential risks. This study aims to provide robust clinical evidence on the effectiveness of the oral supplement in promoting hair growth and reducing hair loss in men affected by androgenetic alopecia, potentially offering a safe and well-tolerated alternative to existing hair loss therapies while ensuring continuous monitoring for any adverse events throughout the treatment period.
Read the detailed description
Nutraceutical foods are those that provide health benefits beyond basic nutrition. These include naturally occurring foods such as fish and vegetables, as well as processed foods like wine, yogurt, and dairy products. These natural compounds or substances exert therapeutic effects on the body, with the term 'nutraceutical' originating from the combination of 'nutrition' and 'therapeutic'
The classification of nutraceuticals is diverse and extensive, encompassing isolated nutrients, herbal products, fruit-derived supplements, dietary supplements, genetically modified foods, and processed products such as cereals, soups, and beverages . This diversity has enabled nutraceuticals to be widely available in commercial products spanning the food, pharmaceutical, herbal, and agro-industrial sectors.
One area of particular interest in nutraceutical research is hair health. The product to study has been developed to manage acute hair loss and to strengthen hair and nails. Thanks to its composition, including L-Cystine, glutathione, vitamins B5 and B6, copper, and zinc, it helps maintain hair and nail health. A new formulation of the product has been designed specifically to improve androgenetic alopecia (AGA) by incorporating natural ingredients that functionally inhibit the 5α-reductase enzyme.
Androgenetic alopecia (AGA) is one of the most common forms of hair loss in both men and women . It is characterized by the miniaturization of hair follicles due to the action of dihydrotestosterone (DHT) on androgen receptors. DHT is derived from testosterone via the 5α-reductase enzyme, which exists in three isoenzymes (types I, II, and III). Type II is most relevant to AGA as it is predominantly found in hair follicles. Many pharmacological interventions for AGA focus on inhibiting DHT's action on the hair follicle. Additionally, various molecules and vitamins are involved in the pathogenesis of AGA and in maintaining the proper cycle and structure of the hair follicle. The rationale for this study is based on the premise that the combination of different natural active ingredients inhibiting the 5α-reductase enzyme can work synergistically to improve signs associated with androgenetic alopecia. Serenoa Repens (Saw Palmetto) Cucurbita Pepo (Pumpkin Seed Oil) Pygeum Africanum Extract L-Cystine Oleanolic Acid Horsetail Extract (Equisetum arvense)
This observational study will evaluate the effects of the product in 30 volunteers receiving the active supplement and 15 receiving a placebo. The primary objective is to determine the supplement's effectiveness on hair health, growth, and hair loss over six months through instrumental (TrichoScan HD Professional 4.0) and subjective (questionnaires) evaluations. The study population consists of 45 male volunteers aged 18 to 45 years with hair growth and loss issues. The study will be conducted in compliance with regulatory guidelines, with careful monitoring of any potential adverse effects to ensure the safety and efficacy of the supplement.
Given that the key active ingredients in the product of study have established safety profiles and are widely used in commercial products, no significant adverse effects are anticipated. However, continuous monitoring will be conducted throughout the study to ensure participant safety and product efficacy. Volunteers will be compensated accordingly for their participation, and the study will be conducted under strict ethical and legal guidelines.
- Conditions
- Androgenetic Alopecia
- Being tested
- Oral Supplement
- Keywords
- MAGA, Androgenetic Alopecia, Natural supplement, Saw Palmetto, Cucurbita Pepo, Alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral SupplementOther
Participants in the Active Comparator group will receive a dietary supplement designed to manage androgenetic alopecia (AGA). The intervention consists of one oral capsule per day for six months, containing active ingredients such as Saw Palmetto, Pumpkin Seed Oil, Pygeum africanum, L-Cystine, Oleanolic Acid, and Horsetail Extract.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Participants in the Placebo Comparator group will receive a placebo capsule identical in appearance to the active treatment but containing inactive ingredients with no known effect on hair growth. The intervention consists of one oral capsule per day for six months, administered under the same conditions as the active group. Receives: Other: Oral Supplement |
| Active Comparator | Active comparator | Participants in the Active Comparator group will receive a dietary supplement designed to manage androgenetic alopecia (AGA). The intervention consists of one oral capsule per day for six months, containing active ingredients such as Saw Palmetto, Pumpkin Seed Oil, Pygeum africanum, L-Cystine, Oleanolic Acid, and Horsetail Extract. Receives: Other: Oral Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Evaluation of Hair Health Benefits After Six Months of Treatment
Hair Growth Assessment Using Phototrichogram Analysis
Description: Evaluation of hair growth parameters using the TrichoScan HD Professional 4.0 system. The analysis will be performed 48 hours after shaving a 1 cm² region of interest (ROI). The following parameters will be measured:
1-Total Hair Count: number of hairs in 1 cm². Unit= number of hairs
Measured: From enrollment to 3 months and 6 months
Total Terminal Count
Total Terminal Count: # terminal hairs. Unit= number of hairs
Measured: From enrollment to 3 months and 6 months
Hair Density
Hair Density: hairs/cm². Unit=hairs/cm²
Measured: From enrollment to 3 months and 6 months
Terminal Hair Density
Terminal Hair Density: terminal hairs/cm². Unit=hairs/cm²
Measured: From enrollment to 3 months and 6 months
Terminal Hair Proportion
Terminal Hair Proportion: % of terminal hairs. Unit=%
Measured: From enrollment to 3 months and 6 months
Anagel and Telogen
Anagen %: anagen. Unit=% Telogen %: telogen. Unit=%
Measured: From enrollment to 3 months and 6 months
Hair Mass
Hair Mass: mm/cm². Unit=mm/cm²
Measured: From enrollment to 3 months and 6 months
Median and Mean Hair Thickness
Median Hair Thickness: μm. Unit=μm Mean Hair Thickness: μm. Unit=μm
Measured: From enrollment to 3 months and 6 months
Hair length
Hair Length: average length. Unit=mm or cm
Measured: From enrollment to 3 months and 6 months
Secondary outcomes (1)
Subjective evaluation questionnaire
Consumer perception of the dietary supplement will be analyzed, including its organoleptic properties, efficacy and functionality, and consumption characteristics.
The scale used in this subjective self-assessment questionnaire is a 4-point Likert scale with the following values: 1 = Strongly disagree, 2 = Disagree, 3 = Agree, and 4 = Strongly agree. A favorable response is defined as selecting either 3 (Agree) or 4 (Strongly Agree). This scale measures the participant's subjective experience regarding the treatment. A higher score indicates a more positive perception of the treatment outcome.
Measured: From enrollment to 3 months and 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 Feb 2025
- Study start7 Oct 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Industrial Farmacéutica Cantabria, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841458
- Sponsor's protocol ID
- P24113a
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 24 Feb 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrumental, Single-Blind, Placebo-Controlled Study Evaluating the Efficacy of a Dietary Supplement on Hair Growth Over 6 Months in 45 Volunteers
- ClinicalTrials.gov ID
- NCT06841458
- Acronym / sponsor ID
- P24113a
- Conditions
- Androgenetic Alopecia
- Keywords
- MAGA, Androgenetic Alopecia, Natural supplement, Saw Palmetto, Cucurbita Pepo, Alopecia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Industrial Farmacéutica Cantabria, S.A.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 Feb 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.
This clinical study is designed to evaluate the efficacy and safety of a dietary supplement CL-P24113a for the management of androgenetic alopecia (AGA) in male subjects aged 18 to 45 years who suffer from alopecia with low hair density, classified as mild to moderate (Hamilton-Norwood stages II, III, and IV). The product is a formulation based on a blend of botanical ingredients and other well-established compounds, including Pumpkin Seed Oil (Curcubita pepo), Saw Palmetto Oil (Serenoa repens), L-Cystine, Prunus africana Bark Extract (Pygeum africanum), Horsetail Extract (Equisetum arvense), Olive Leaf Extract, among other excipients. These components have a well-documented history of safe use in both topical and oral applications with supporting safety information from international bodies such as EFSA. In this instrumental, single-blind, placebo-controlled study, 45 volunteers will be divided into two groups, with 30 subjects receiving the supplement and 15 subjects receiving a placebo. All participants will ingest one capsule per day, preferably in the morning with a glass of water, over a 6-month treatment period. Prior to study initiation, subjects must complete a 30-day washout period using a neutral shampoo and agree not to apply any other topical or oral hair treatments in the target area throughout the study. The study will evaluate efficacy through both instrumental and subjective assessments. Instrumental evaluations will be conducted at 3 and 6 months using the TrichoScan HD Professional 4.0 system to measure hair growth parameters such as total hair count, hair density per cm², proportion of hairs, terminal hair count and density, proportion of terminal hairs, as well as the percentages of anagen and telogen hairs. Additionally, measurements of hair thickness including hair mass per cm², median and mean hair thickness in micrometers, overall scalp hair density, and median hair length will be recorded. Subjective evaluations will be performed via questionnaires administered at 1.5, 3, 4.5, and 6 months to capture participants' perceptions regarding hair growth and hair loss. The study is overseen by Principal Investigator at Dermaclaim Lab S.L. Regulatory compliance will be ensured by obtaining written informed consent for both study participation and data protection, and all subjects will be thoroughly briefed on study requirements and potential risks. This study aims to provide robust clinical evidence on the effectiveness of the oral supplement in promoting hair growth and reducing hair loss in men affected by androgenetic alopecia, potentially offering a safe and well-tolerated alternative to existing hair loss therapies while ensuring continuous monitoring for any adverse events throughout the treatment period.
Detailed description
Nutraceutical foods are those that provide health benefits beyond basic nutrition. These include naturally occurring foods such as fish and vegetables, as well as processed foods like wine, yogurt, and dairy products. These natural compounds or substances exert therapeutic effects on the body, with the term 'nutraceutical' originating from the combination of 'nutrition' and 'therapeutic'
The classification of nutraceuticals is diverse and extensive, encompassing isolated nutrients, herbal products, fruit-derived supplements, dietary supplements, genetically modified foods, and processed products such as cereals, soups, and beverages . This diversity has enabled nutraceuticals to be widely available in commercial products spanning the food, pharmaceutical, herbal, and agro-industrial sectors.
One area of particular interest in nutraceutical research is hair health. The product to study has been developed to manage acute hair loss and to strengthen hair and nails. Thanks to its composition, including L-Cystine, glutathione, vitamins B5 and B6, copper, and zinc, it helps maintain hair and nail health. A new formulation of the product has been designed specifically to improve androgenetic alopecia (AGA) by incorporating natural ingredients that functionally inhibit the 5α-reductase enzyme.
Androgenetic alopecia (AGA) is one of the most common forms of hair loss in both men and women . It is characterized by the miniaturization of hair follicles due to the action of dihydrotestosterone (DHT) on androgen receptors. DHT is derived from testosterone via the 5α-reductase enzyme, which exists in three isoenzymes (types I, II, and III). Type II is most relevant to AGA as it is predominantly found in hair follicles. Many pharmacological interventions for AGA focus on inhibiting DHT's action on the hair follicle. Additionally, various molecules and vitamins are involved in the pathogenesis of AGA and in maintaining the proper cycle and structure of the hair follicle. The rationale for this study is based on the premise that the combination of different natural active ingredients inhibiting the 5α-reductase enzyme can work synergistically to improve signs associated with androgenetic alopecia. Serenoa Repens (Saw Palmetto) Cucurbita Pepo (Pumpkin Seed Oil) Pygeum Africanum Extract L-Cystine Oleanolic Acid Horsetail Extract (Equisetum arvense)
This observational study will evaluate the effects of the product in 30 volunteers receiving the active supplement and 15 receiving a placebo. The primary objective is to determine the supplement's effectiveness on hair health, growth, and hair loss over six months through instrumental (TrichoScan HD Professional 4.0) and subjective (questionnaires) evaluations. The study population consists of 45 male volunteers aged 18 to 45 years with hair growth and loss issues. The study will be conducted in compliance with regulatory guidelines, with careful monitoring of any potential adverse effects to ensure the safety and efficacy of the supplement.
Given that the key active ingredients in the product of study have established safety profiles and are widely used in commercial products, no significant adverse effects are anticipated. However, continuous monitoring will be conducted throughout the study to ensure participant safety and product efficacy. Volunteers will be compensated accordingly for their participation, and the study will be conducted under strict ethical and legal guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Other: Oral SupplementParticipants in the Placebo Comparator group will receive a placebo capsule identical in appearance to the active treatment but containing inactive ingredients with no known effect on hair growth. The intervention consists of one oral capsule per day for six months, administered under the same conditions as the active group. |
| Active Comparator | Active comparator | Other: Oral SupplementParticipants in the Active Comparator group will receive a dietary supplement designed to manage androgenetic alopecia (AGA). The intervention consists of one oral capsule per day for six months, containing active ingredients such as Saw Palmetto, Pumpkin Seed Oil, Pygeum africanum, L-Cystine, Oleanolic Acid, and Horsetail Extract. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Written consent for LOPD compliance.
- Written informed consent for study DC.506.36.117.
- Gender: Male.
- Age: Between 18 and 45 years.
- Diagnosis of alopecia with low hair density, classified as mild to moderate (stages II, III, and IV on the Hamilton-Norwood scale).
Key exclusion criteria (7 listed)
- Individuals with gastrointestinal diseases (e.g., diabetes, gastritis, Crohn's disease, celiac disease, ulcers, intolerances, etc.).
- Individuals with other physiological disorders (e.g., diabetes, hypertension, dyslipidemia) and/or gallstones.
- Individuals undergoing medical treatment in the weeks prior to the study that may interfere with study assessments (as determined by the investigator), particularly those who are currently taking or have taken 5α-reductase inhibitors (Finasteride, Dutasteride, Minoxidil, etc.) within the last three months.
- Individuals who have undergone hair restoration treatments at any point in their lives, including hair transplants, mesotherapy, or platelet-rich plasma (PRP) therapy.
- Individuals following an atypical diet or planning to change their dietary routine during the study period.
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 |
|---|---|---|
| Oral SupplementParticipants in the Active Comparator group will receive a dietary supplement designed to manage androgenetic alopecia (AGA). The intervention consists of one oral capsule per day for six months, containing active ingredients such as Saw Palmetto, Pumpkin Seed Oil, Pygeum africanum, L-Cystine, Oleanolic Acid, and Horsetail Extract. | Other | Active Comparator, Placebo Comparator |
Primary outcome
Objective Evaluation of Hair Health Benefits After Six Months of Treatment
Time frame: From enrollment to 3 months and 6 months
Hair Growth Assessment Using Phototrichogram Analysis Description: Evaluation of hair growth parameters using the TrichoScan HD Professional 4.0 system. The analysis will be performed 48 hours after shaving a 1 cm² region of interest (ROI). The following parameters will be measured: 1-Total Hair Count: number of hairs in 1 cm². Unit= number of hairs
Total Terminal Count
Time frame: From enrollment to 3 months and 6 months
Total Terminal Count: # terminal hairs. Unit= number of hairs
Hair Density
Time frame: From enrollment to 3 months and 6 months
Hair Density: hairs/cm². Unit=hairs/cm²
Terminal Hair Density
Time frame: From enrollment to 3 months and 6 months
Terminal Hair Density: terminal hairs/cm². Unit=hairs/cm²
Terminal Hair Proportion
Time frame: From enrollment to 3 months and 6 months
Terminal Hair Proportion: % of terminal hairs. Unit=%
Anagel and Telogen
Time frame: From enrollment to 3 months and 6 months
Anagen %: anagen. Unit=% Telogen %: telogen. Unit=%
Hair Mass
Time frame: From enrollment to 3 months and 6 months
Hair Mass: mm/cm². Unit=mm/cm²
Median and Mean Hair Thickness
Time frame: From enrollment to 3 months and 6 months
Median Hair Thickness: μm. Unit=μm Mean Hair Thickness: μm. Unit=μm
Hair length
Time frame: From enrollment to 3 months and 6 months
Hair Length: average length. Unit=mm or cm
1 secondary outcome
Subjective evaluation questionnaire
Time frame: From enrollment to 3 months and 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 Feb 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Supplement in people with Androgenetic Alopecia, run by Industrial Farmacéutica Cantabria, S.A. at 2 sites 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact DermaClaim (96 187 45 82, dermaclaim@dermaclaim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Evaluation of Hair Health Benefits After Six Months of Treatment (time frame: From enrollment to 3 months and 6 months). The study lists 9 primary outcomes in all. 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 Feb 2025.