Otherwise healthy men with androgenetic alopecia (Hamilton-Norwood Scale IIIvertex to VI) in the temple and vertex area. MedDRA version: 13.1 Level: PT Classification code 10068168 Term: Androgenetic alopecia System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Men's Rogaine(R) foam
Product Name: Men's Rogaine(R) foam
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: MINOXIDIL
CAS Number: 38304-91-5
Concentration unit: % (W/W) percent wei
Sponsors
Charité-Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, CRC
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male, age 18 to 70, in general good health. - Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale IIIvertex to VI - Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject (or a legally acceptable representative), has been informed of all pertinent aspects of the trial. - 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. - Accepting the Information form plus accepting and signing the Informed Consent form. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 62 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - Known to be hypersensitive to minoxidil, hair dye (p-phenylendiamin), tattoo ink, fragrances, hair gel or any vehicle components - Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazol or the like (e. g. Terzolin®) in the target region interfering with the study product or examination method - Current or 3 months dated back use of topical treatment in the target regions taken for more then 2 consecutive weeks interfering with the study product (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 study product or examination method (beta blocker, Cimetidine, Diazoxid, Isotretionin, corticosteroids, vitamin A intake above 10000 IU per day) - Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Durasteride 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, non-breathable wigs or 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 study product 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) - Individuals who are institutionalized by court or regulatory order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is the change of target area non-vellus hair count in the temple region (t-TAHC) [n/cm²] after 24 weeks;Secondary Objective: Change of target area non-vellus hair count in the vertex region (v-TAHC) [n/cm²] compared to baseline after 24, 52, 76 and 104 weeks Change of cumulative hair width in non-vellus hair in temple and vertex region (t-TAHW; v-TAHW) [mm/cm²] compared to baseline after 24, 52, 76 and 104 weeks Change of t-TAHC, v-TAHC, t-TAHW and v-TAHW comparing 5% MTF and Placebo Topical Foam (plaTF) groups Global expert panel rating change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via assessment of global temple and vertex photographs Subject rating of change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via global temple and vertex photographs Assessing the investigational products safety by means of clinical examination (local intolerance, AE, SAE);Primary end point(s): Primary endpoint is the change of target area non-vellus hair count in the temple region (t-TAHC) [n/cm²] compared to baseline after 24 weeks;Timepoint(s) of evaluation of this end point: Baseline, week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change of target area non-vellus hair count in the vertex region (v-TAHC) [n/cm²] compared to baseline after 24, 52, 76 and 104 weeks Change of cumulative hair width in non-vellus hair in temple and vertex region (t-TAHW; v-TAHW) [mm/cm²] compared to baseline after 24, 52, 76 and 104 weeks Change of t-TAHC, v-TAHC, t-TAHW and v-TAHW comparing 5% MTF and Placebo Topical Foam (plaTF) groups Global expert panel rating change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via assessment of global temple and vertex photographs Subject rating of change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via global temple and vertex photographs ;Timepoint(s) of evaluation of this end point: Baseline, week 24, week 52, week 76, week 104 | — |
Countries
Germany
Contacts
Public ContactKathrin Hillmann
Charité-Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, CRC
Outcome results
None listed