Actively Recruiting
Instrumental, Single-Blind, Placebo-Controlled Study Evaluating the Efficacy of a Dietary Supplement on Hair Growth Over 6 Months in 45 Volunteers
Led by Industrial Farmacéutica Cantabria, S.A. · Updated on 2025-02-24
45
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of a dietary supplement called CL-P24113a for managing androgenetic alopecia (AGA) in men aged 18 to 45 years with mild to moderate hair loss. The study involves 45 male volunteers with low hair density classified as Hamilton-Norwood stages II, III, and IV. The supplement contains a blend of botanical ingredients such as Pumpkin Seed Oil, Saw Palmetto Oil, L-Cystine, Prunus africana Bark Extract, Horsetail Extract, and Olive Leaf Extract, all known for their safe use in hair and nail health. Participants will be randomly assigned to two groups: 30 will receive the active dietary supplement and 15 will receive a placebo capsule identical in appearance. Each participant will take one capsule daily for six months, preferably in the morning with water. Before starting the treatment, all subjects must complete a 30-day washout period using a neutral shampoo and agree not to use other hair treatments during the study. The study is single-blind and placebo-controlled. Volunteers will have their hair health assessed instrumentally using the TrichoScan HD Professional 4.0 system at 3 and 6 months to measure various hair growth parameters, including hair count, density, thickness, and hair cycle phases. Subjective evaluations through questionnaires will be collected at 1.5, 3, 4.5, and 6 months to capture participants' perceptions of hair growth and loss. Safety monitoring and adherence to study requirements will be ensured throughout the treatment period, which lasts six months.
CONDITIONS
Brief Title
Six-Month Single-Blind, Placebo-Controlled Study of a Dietary Supplement Supplement on Hair Growth in 45 Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written consent for data protection compliance
- Written informed consent for study participation
- Male gender
- Age between 18 and 45 years
- Diagnosis of alopecia with low hair density, mild to moderate (Hamilton-Norwood stages II, III, and IV)
- Willingness to have a 1-2 cm² scalp area shaved during the study
- Last participation in a hair health clinical study ended at least six months prior
- Completion of a 30-day washout period using a neutral shampoo
- No use of other topical or oral hair treatments in the target area during the study period
You will not qualify if you...
- Gastrointestinal diseases such as diabetes, gastritis, Crohn's disease, celiac disease, ulcers, or intolerances
- Other physiological disorders including diabetes, hypertension, dyslipidemia, or gallstones
- Recent medical treatments that may interfere with study assessments
- Use of 5-alpha-reductase inhibitors (Finasteride, Dutasteride, Minoxidil) within the last three months
- Previous hair restoration treatments including hair transplants, mesotherapy, or platelet-rich plasma therapy
- Following or planning to change an atypical diet during the study
- Enrollment in another clinical study with similar characteristics during this study
- Inability to understand informed consent or follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take one oral capsule daily of either the dietary supplement or a placebo for six months to evaluate effects on hair growth and health.
Visits at enrollment, 3 months, and 6 months for assessments
Trial Site Locations
Total: 2 locations
1
DermaClaim
Valencia, Valencia, Spain, 46020
Actively Recruiting
2
DermaClaim
Valencia, Spain
Actively Recruiting
Research Team
D
DermaClaim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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