Six-Month Single-Blind, Placebo-Controlled Study of a Dietary Supplement Supplement on Hair Growth in 45 Volunteers

NCT06841458 | Recruiting

• 1 other identifier: P24113a
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Androgenetic Alopecia

Keywords

MAGA; Androgenetic Alopecia; Natural supplement; Saw Palmetto; Cucurbita Pepo; Alopecia

Outcome Measures

Primary Outcomes (9)

• 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

  From enrollment to 3 months and 6 months

• Total Terminal Count

  Total Terminal Count: # terminal hairs. Unit= number of hairs

  From enrollment to 3 months and 6 months

• Hair Density

  Hair Density: hairs/cm². Unit=hairs/cm²

  From enrollment to 3 months and 6 months

• Terminal Hair Density

  Terminal Hair Density: terminal hairs/cm². Unit=hairs/cm²

  From enrollment to 3 months and 6 months

• Terminal Hair Proportion

  Terminal Hair Proportion: % of terminal hairs. Unit=%

  From enrollment to 3 months and 6 months

• Anagel and Telogen

  Anagen %: anagen. Unit=% Telogen %: telogen. Unit=%

  From enrollment to 3 months and 6 months

• Hair Mass

  Hair Mass: mm/cm². Unit=mm/cm²

  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

  From enrollment to 3 months and 6 months

• Hair length

  Hair Length: average length. Unit=mm or cm

  From enrollment to 3 months and 6 months

Secondary Outcomes (1)

• Subjective evaluation questionnaire

  From enrollment to 3 months and 6 months

Study Arms (2)

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.

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.

Other: Oral Supplement

Interventions

Oral Supplement OTHER

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.

Active Comparator; Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Industrial Farmacéutica Cantabria, S.A.: lead

Study Sites (2)

DermaClaim

Valencia, Valencia, 46020, Spain

RECRUITING

DermaClaim

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

DermaClaim

CONTACT

96 187 45 82; dermaclaim@dermaclaim.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 24, 2025
• Study Start: October 7, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)