Androgenetic Alopecia Hamilton-Norwood IIIv-IV male patients MedDRA version: 16.1 Level: PT Classification code 10068168 Term: Androgenetic alopecia System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Regaine® Männer Schaum
Product Name: Regaine Männer Schaum
Product Code: D11AX01
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: MINOXIDIL
Other descriptive name: Regaine Männer S
Sponsors
Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science
Eligibility
Sex/Gender
Male
Inclusion 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Identifying changes on gene expression level associated with minoxidil treatment with special regard to profiles of genes relevant for AGA treatment and for specific effects of early minoxidil action, respectively (1) minoxidil sulfotransferases, potassium channel regulation (2) inflammation, (3) vasoregulation and (4) sexual hormone production and metabolism; ;Secondary Objective: -Monitor changes of scalp microenvironment using conventional techniques: skin surface lipid collection, novel approach to assess scalp microenvironment by mini-zone CSSS; -Comparing results obtained with novel techniques with clinical observations (e.g., onset and extent of shedding), patient complaints (.e.g., itching, trichodynia) and conventional clinical readouts for assessment of minoxidil-induced hair growth (e.g.macrophotography); -Drawing conclusions on whether one of the novel approaches could help provide early clinical read-out parameters of minoxidil efficacy which could shorten the duration of future clinical trials in this field ;Primary end point(s): - Gene expression differences on affected and uneffected area of alopecia - efficiency of 5% Minoxidil on affected area according hair density and number for a study period of 8 weeks;Timepoint(s) of evaluation of this end point: End of study and trend of the change in variables during study course (Visit 1 - 9) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Germany
Contacts
Public ContactDr. Sabine Fimmel
Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science
Outcome results
None listed