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

NCT ID: NCT06841458

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-07
• Study Completion Date: 2025-06-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Oral Supplement

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Oral Supplement

Intervention Type: 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.

Interventions

Oral Supplement

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Industrial Farmacéutica Cantabria, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DermaClaim

Valencia, Valencia, Spain

Site Status: RECRUITING

DermaClaim

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

DermaClaim

Role: CONTACT

dermaclaim@dermaclaim.com

96 187 45 82

Facility Contacts

DermaClaim

Role: primary

dermaclaim@dermaclaim.com

+34961874582

DermaClaim

Role: primary

dermaclaim@dermaclaim.com

961874582

Other Identifiers

P24113a

Identifier Type: -

Identifier Source: org_study_id