Investigator-initiated clinical research trial on the effects of 5% Minoxidil topical foam on gene expression, hair growth and scalp microenvironment in men with androgenetic alopecia

Phase 1

• Conditions: Androgenetic Alopecia Hamilton-Norwood IIIv-IV male patients; MedDRA version: 16.1Level: PTClassification code 10068168Term: Androgenetic alopeciaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-004130-15-DE
• Lead Sponsor: Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-05
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

•healthy male patients 21 - 45 years of age
•Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale IIIvertex to IV
•negative plug test occipital
•Willing to maintain the same hairstyle, hair length and hair color throughout the study
•Subjects who are willing and able to comply with scheduled visits, treatment plan, mini-tattoo and other trial procedures
•Written informed consent of the patients

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink, fragrances, hair gel or any vehicle components
•Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazole or the like (e. g. Terzolin®) in the target region interfering with the CTM or examination method
•Current or 3 months dated back use of topical treatment in the target regions taken for more than 2 consecutive weeks interfering with the CTM (topical corticosteroids, aminexil, minoxidil, estrogens)
•Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the CTM or examination method (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake above 10000 IU per day)
•Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Dutasteride or a similar product
•Within past 12 months undergoing chemotherapy or receiving cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp
•Current or prior enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.
•Presence of hair transplants, hair weaves or non-breathable wigs and hair bonding
•Current or 2 months dated back severe diet or presenting a history of eating disorder
•Any dermatological disorders of the scalp in the target region with the possibility of interfering with the CTM or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy
•Untreated persisting hypertension
•Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia
•Other severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results (e. g. untreated hypothyroidism)
•Persons who are institutionalized because of legal or regulatory order.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified