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

NCT04884347 | Completed

• 1 other identifier: NHL00.100.13.00_ IT0002110/20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in the number of hair in anagen and telogen phases at day 30 and 86.

  The total number of hair (hair density) and the number of hair in the anagen phase will be determined by phototricogram. Briefly, all hairs in a 2 sq cm area are trimmed 1 mm from the skin surface. The hair is dyed and a baseline photograph is taken. After 48h, the same region is photographed again. By comparing with the baseline picture, one can observe as to which hair fibers have grown (follicles in anagen) and which have not (follicles in telogen) and the density of the hair (the number of hairs in the photograph). Anagen hair will be manually counted comparing side by side the photographs taken at each checkpoint and 48 hours after. Telogen hair will be calculated as the difference between the total hair number and the anagen hair number.

  Day 0, Day 30, Day 86

Secondary Outcomes (3)

• Changes from baseline in hair radiance (au) at day 28 and day 84

  Day 0, Day 28, Day 84

• Changes from baseline in hair elongation (%) at day 28 and day 84

  Day 0, Day 28, Day 84

• Changes from baseline in hair breakage force (cN) at day 28 and day 84

  Day 0, Day 28, Day 84

Study Arms (2)

Alline proMEN

EXPERIMENTAL

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)).

Dietary Supplement: Alline proMEN

Placebo

PLACEBO COMPARATOR

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).

Dietary Supplement: Placebo

Interventions

Alline proMEN DIETARY_SUPPLEMENT

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

Alline proMEN

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Criteria related to subject's health
• Subjects considered "healthy subject" by the Investigator
• 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

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Laboratoires Pharmaceutiques Trenker: lead
• Complife Italia S.r.l: collaborator
• Università degli Studi di Pavia: collaborator

Study Sites (1)

Complife Italia S.r.l

Pavia, 27028, Italy

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

• Vincenzo Nobile, PhD

  Complife Italia S.r.l

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 13, 2021
• Study Start: August 31, 2020
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)