Instrumental, Single-Blind, Placebo-Controlled Study Evaluating the Efficacy of a Dietary Supplement on Hair Growth Over 6 Months in 45 Volunteers

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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). 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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
DermaClaim
RECRUITING
Valencia
DermaClaim
RECRUITING
Valencia
Contact Information
Primary
DermaClaim
dermaclaim@dermaclaim.com
96 187 45 82
Time Frame
Start Date: 2024-10-07
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 45
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Industrial Farmacéutica Cantabria, S.A.

This content was sourced from clinicaltrials.gov