Evaluation of the Efficacy of a Food Supplement in Reducing Hair Loss in Male Subjects

NCT ID: NCT04884347

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2021-02-04

Brief Summary

According to the American Hair Loss Association, by the age of 35, two-thirds of American men will have some degree of appreciable hair loss, and by the age of 50, approximately 50 to 85% of men will have significant hair thinning.

Hair is an essential aspect of human appearance and can have a significant impact on a person's self-esteem, mood and quality of life. Unfortunately, current treatment options can be costly, tedious or painful. They are also associated with numerous side effects.

Here, the investigators aimed at evaluating the effect of a new food supplement on hair condition in young men suffering from hair loss. A second goal was to determine tolerability.

Conditions

Hair Loss

Study Design

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

Study Groups

Alline proMEN

The qualitative and quantitative formula is as follows: 500 mg Keratin, 225 mg Inactive dried yeast rich in vitamin (containing 200 mg Saccharomyces cerevisiae 100% inactivated, 11.218.4 mg Vitamin B3, 6.8-7.2 mg Vitamin B5, 1.6-1.8 mg Vitamin B6, 1.6-1.8 mg Vitamin B2, 1.6 -1.8 mg Vitamin B1, 0.2-0.4 mg Vitamin B9, 0.2 mg Vitamin B8, 5.6 μg Vitamin B12), 150 mg Venus hair fern extract, 117.6 mg Iron gluconate (containing 14.7 mg Iron), 84.2 mg Sodium ascorbate coated, 76.8 mg Zinc gluconate (11 mg Zinc) 24 mg Beta carotene 20%, 14.8 mg Vitamin E, 256.3 mg Acacia gum, 100 mg Microcrystalline cellulose, 11.3 mg Magnesium stearate, 78 mg White coating (containing: 23.4-39 mg Hydroxypropylmethylcellulose (E464), 15.6-23.4 mg Calcium sulfate anhydrous (E516), 15.6-23.4 mg Magnesium carbonate, light (E504), 7.8-15.6 mg Hydroxypropylcellulose (E463), 3.9-11.7 mg Stearic acid (E570)).

Group Type: EXPERIMENTAL

Alline proMEN

Intervention Type: DIETARY_SUPPLEMENT

1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months

Placebo

1095 mg Microcrystalline cellulose, 5 mg Magnesium stearate, 55 mg White coating (containing: 16.5-27.5 mg Hydroxypropylmethylcellulose (E464), 11.0-16.5 mg Calcium sulfate anhydrous (E516), 11.0-16.5 mg Magnesium carbonate, light (E504), 5.5-11.0 mg Hydroxypropylcellulose (E463), 2.8-8.2 mg Stearic acid (E570).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months

Interventions

Alline proMEN

1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months

Intervention Type: DIETARY_SUPPLEMENT

Placebo

1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Criteria related to population

• Male subjects
• Caucasian ethnicity
• Subjects aged between 25 and 55 years old
• Subjects with all type of scalp and hair
• Phototype I to IV included, according to Fitzpatrick classification
• Subjects registered with health social security or health social insurance
• Subjects having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
• Subjects certifying the truth of the personal information declared to the Investigator
• Subjects able to understand the language used in the investigation centre and the information given
• Subjects able to comply with the protocol and follow protocol's constraints and specific requirements

2. Criteria related to subject's health

• Subjects considered "healthy subject" by the Investigator

3. Criteria related to hair loss disorders

• Acute hair loss with a proportion of hair in telogen phase superior or equal to 20% as assessed by phototricogram
• Subjects agreeing to preserve a length of hair longer than 10 cm during the study
• Subjects agreeing to have a zone of 1.8 cm² shaved on the scalp

Exclusion Criteria

1. Criteria related to the population

• Subjects taking part or planning to participate to another clinical trial during the study in the same or another investigation centre
• Subjects deprived of freedom by administrative or legal decision or under guardianship Subjects not able to be contacted in case of emergency.
• Subjects admitted in a sanitary or social facility
• Subjects planning a hospitalisation during the study
• Subjects belonging to the staff of the investigation centre
• subjects who have participated in another clinical trial with anti-hair loss product or treatment within the last 12 weeks before the inclusion visit

2. Criteria related to subject's health

• Subjects having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
• Subjects being in course of a long-treatment or intending to have one, in particular with aspirin, products containing aspirin, corticoids, beta blockers (including eye drops), immuno-suppressive and/or desensitisation drugs or under any treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
• Subjects being vaccinated within the 3 weeks prior to the study or intending to be vaccinated during the course of the study
• Subjects having a skin condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements Subjects having personal history of cosmetic, drug or domestic products irritative reactions Subjects having personal history of cosmetic products or adhesive plaster allergy Subjects having personal history of drug, domestic products and food allergy with no progressive or recent clinical features of allergy

3. Criteria related to hair loss disorders

• Subjects who have any other diagnosed hair disorder or hair disease.
• Subjects having excessive and/or fluctuating hair shedding for more than 6 months Subjects with Inflammatory skin disease or progressive skin lesion on the scalp (psoriasis, seborrhoeic dermatitis, severe erythema, severe excoriation, severe sunburn, etc.). Subjects having a scalp lesion in relief which may be traumatized
• Subjects with history of hypersensitivity or intolerance to any of the following components applied by topical route: ethyl alcohol, components of the used hair dye, components of the studied product.
• Subjects having systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before inclusion visit: Retinoids, Anti-mitotic, cytotoxic drugs other than antineoplastic, Anti-androgens (spironolactone, flutamide), androgens, Anti-epileptic agents, interferon alpha
• Subjects having systemic or local androgenetic alopecia treatment or product, taken or applied (Minoxidil, Aminexil, Finasteride, Dutasteride, cosmetic solution or capsules with vitamin B, zinc, caffeine…) for more than 4 consecutive weeks during the last 24 weeks before the inclusion visit
• Subjects having any other local treatment applied on the scalp (non-steroidal anti-inflammatory, ketoconazole…) within the last 2 weeks before the inclusion visit
• Subjects having any following hair care within the last 2 weeks before the inclusion visit or foreseen during the study (except for dying): dandruff shampoo, antifungal shampoo, dyeing, bleaching, perm
• Subjects having any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam…)
• Subjects under radiotherapy, chemotherapy at any time Subjects having scalp surgery (hair transplants, laser) at any time

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Complife Italia S.r.l

UNKNOWN

Sponsor Role: collaborator

Università degli Studi di Pavia

UNKNOWN

Sponsor Role: collaborator

Laboratoires Pharmaceutiques Trenker

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincenzo Nobile, PhD

Role: STUDY_DIRECTOR

Complife Italia S.r.l

Locations

Complife Italia S.r.l

Pavia, , Italy

Countries

Italy

Other Identifiers

NHL00.100.13.00_ IT0002110/20

Identifier Type: -

Identifier Source: org_study_id