Clinical trial NCT04884347: Evaluation of the Efficacy of a Food Supplement in Reducing Hair Loss in Male Subjects
Official title: Double Blind, Randomized, Placebo-controlled Assessment of the Efficacy of a Food Supplement in Reducing Hair Loss in Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Loss
Lead sponsor: Laboratoires Pharmaceutiques Trenker
Sponsor class: INDUSTRY
Collaborators: name: Complife Italia S.r.l
name: Università degli Studi di Pavia
First posted: 2021-05-13
Enrollment: 100
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
   * if the subject is under systemic pharmacological treatment, this should be stable for at least one month before the study start and do not change over the study period, excluded the treatments specified in noninclusion criteria"
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

Primary outcomes:
measure: Changes from baseline in the number of hair in anagen and telogen phases at day 30 and 86.
timeFrame: Day 0, Day 30, Day 86
Secondary outcomes:
measure: Changes from baseline in hair radiance (au) at day 28 and day 84
timeFrame: Day 0, Day 28, Day 84
measure: Changes from baseline in hair elongation (%) at day 28 and day 84
timeFrame: Day 0, Day 28, Day 84
measure: Changes from baseline in hair breakage force (cN) at day 28 and day 84
timeFrame: Day 0, Day 28, Day 84
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Complife Italia S.r.l
Study officials:
affiliation: Complife Italia S.r.l
name: Vincenzo Nobile, PhD
role: STUDY_DIRECTOR
References: