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 - AGA Array Minoxidil

Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science0 sites12 target enrollmentMarch 5, 2014

ConditionsAndrogenetic 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]

DrugsRegaine® Männer Schaum

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Androgenetic Alopecia Hamilton-Norwood IIIv-IV male patients
Sponsor: Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science
Enrollment: 12
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 5, 2014

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science

Eligibility Criteria

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

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