Dietary supplement for hair growth in men with androgenetic alopecia
Instrumental, Single-Blind, Placebo-Controlled Study Evaluating the Efficacy of a Dietary Supplement on Hair Growth Over 6 Months in 45 Volunteers
This study is testing a new dietary supplement to see if it can help men aged 18 to 45 with mild to moderate hair loss grow more hair and improve hair health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | Industrial Farmacéutica Cantabria, S.A. Industry-sponsored |
| Locations | 2 sites (Valencia, Valencia and 1 other locations) |
| Trial ID | NCT06841458 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the efficacy and safety of a dietary supplement, CL-P24113a, designed to manage androgenetic alopecia (AGA) in male participants aged 18 to 45 with mild to moderate hair loss. The supplement contains a blend of botanical ingredients, including Pumpkin Seed Oil and Saw Palmetto, aimed at inhibiting the 5α-reductase enzyme, which contributes to hair follicle miniaturization. In a single-blind, placebo-controlled design, 45 volunteers will be divided into two groups, with 30 receiving the supplement and 15 receiving a placebo. The study will assess the impact of the supplement on hair density and overall hair health over a six-month period.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 to 45 with mild to moderate androgenetic alopecia as classified by the Hamilton-Norwood scale.
Not a fit: Patients with gastrointestinal diseases or other physiological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural and effective treatment option for men suffering from androgenetic alopecia.
How similar studies have performed: While there have been studies on similar nutraceutical approaches for hair loss, the specific formulation and methodology of this study may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
Where this trial is running
Valencia, Valencia and 1 other locations
- DermaClaim — Valencia, Valencia, Spain (Recruiting)
- DermaClaim — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: DermaClaim
- Email: dermaclaim@dermaclaim.com
- Phone: 96 187 45 82
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.