Alopecia Androgentica
Conditions
Interventions
Product Name: 5% Minoxidil Topical Gel
Product Code: F13496-121
Pharmaceutical Form: Gel
INN or Proposed INN: MINOXIDIL
CAS Number: 38304-91-5
Concentration unit: % (W/W) percent weight/weight
Concen
Sponsors
Johnson & Johnson Consumer Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Men, ages 18 to 49 years with androgenetic alopecia (male pattern hair loss; MPHL) of Hamilton-Norwood patterns IIIv, IV, or V, 2.Willingness to have a target area of 1.9 cm diameter (~3cm2) shaved and a dot tattoo placed in the application area of the scalp four times during the study. 3.Willing to use the same shampoo and/or conditioner and maintain the same haircare habits and products during the study. 4.Willingness to maintain the same approximate hair length, hairstyle, hair color, and hair regimen throughout the study as per the protocol. No changes are permitted. 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 140 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.“Buzz” cut hairstyle, defined as hair cut to less than 2.5 cm in length. 2.History of hair transplants, scalp reductions or hair weaves, or desire to continue use of non-breathable wigs. 3.Known hypersensitivity to minoxidil, or to the ingredients in topical minoxidil preparations. 4.Known allergy to components used in dot tattoo. 5.Individuals with a past history or current evidence of hypertension (BP>140/90), hypotension (BP< 90/60), or cardiac, liver, kidney or endocrine disease of any kind, whether or not it is currently being treated with any form of medication 6.History of any active or untreated cancer excluding basal cell or squamous cell carcinoma of non-scalp areas within the past five years. 7.Presence or history of any concomitant types of hair loss including, but not limited to telogen effluvium, alopecia areata, and scarring alopecia. 8.Dermatologic disorders of the scalp other than male pattern hair loss (MPHL or FPHL), including eczema, fungal or bacterial infections, seborrheic dermatitis, atopic dermatitis, scarring alopecia, psoriasis, folliculitis, etc. that require chronic use of medication for control, or evidence of follicular drop-out suggestive of a destructive follicular condition. 9.Current or recent history (within six months) of severe dietary or weight changes or has a history of eating disorder as per Investigator’s judgement. 10.History of any underlying medical problems that could adversely affect hair growth, such as HIV infection, connective tissue disease, inflammatory bowel disease, uncontrolled thyroid disease, or other endocrine disorders. 11.Use of anti-dandruff containing ketoconazole, anti-psoriatic or anti-seborrhoeic dermatitis shampoo during the study or within one month prior to the Baseline visit. 12.Application of topical minoxidil preparation or any other topical Over-the counter (OTC) or prescription medication for hair re-growth to scalp for 4 weeks or more during the six months before enrollment. 13.Use of any topical or ocular prostaglandins (Latisse®, bimatoprost, latanoprost, or other prostaglandin ophthalmic solutions) unless taken for 4 months or greater prior to baseline. 14.Use of vitamin A supplements or a vitamin A dietary intake exceeding 10,000 IU/day. 15.Current or prior use of oral hair re-growth medications (finasteride, other 5-a-reductase inhibitors), within one year or nutraceuticals/botanicals for 3 months before enrollment. 16.Within the past 3 months before the Baseline visit, use of systemic cimetidine or topical ketoconazole (for more than 2 consecutive weeks). 17.Use of systemic 5-a-reductase inhibitors and/or anti-androgens, isotretinoin or other retinoids within 12 months prior to the Baseline visit. 18.Currently using, or has used systemic minoxidil for more than 4 continuous weeks, within the last 6 months prior to the Baseline visit. 19.Current or prior use (within the previous six months) of anti-seizure drugs, beta blockers, diuretics, or anti-androgens (e.g., spironolactone, flutamide), vasodilators (diazoxide), other than at stable doses for 6 months prior to the Baseline visit with no anticipated change during the study. 20.Current or prior use of immunomodulatory/immunosuppressive drugs (e.g., cyclosporin), chemotherapy/cytotoxic agents, and/or radiation therapy (to the scalp) during the study or within 12 months prior to Baseline. 21.Within the past 2 months prior to the Baseline visit, use of systemic or topical corti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of two formulations of minoxidil, 5% minoxidil topical gel (5% MTG) and 5% minoxidil topical foam (5% MTF), for hereditary hair loss in men. ;Secondary Objective: •To evaluate hair regrowth based on subject self-assessment of product efficacy. •To evaluate the safety and tolerability of 5% MTG and 5% MTF. ;Primary end point(s): Change from Baseline in total non-vellus TAHC at week 16 (measured by computerized Hair MetrixSM system based on macrophotographs). ;Timepoint(s) of evaluation of this end point: Visit 2 (Baseline), Visit 3 (Evaluation), Visit 4 (Evaluation) and Visit 5 (Evaluation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change from Baseline in total non-vellus TAHC at weeks 8 and 12. •Change from Baseline in non-vellus TAHW at weeks 8, 12 and 16. •Subject rating of hair loss condition in the vertex region at weeks 8, 12 and 16 via global photographs ;Timepoint(s) of evaluation of this end point: Visit 2 (Baseline), Visit 3 (Evaluation), Visit 4 (Evaluation), Visit 5 (Evaluation) | — |
Countries
Germany
Contacts
Public ContactVP, Global Regulatory Affairs
Johnson & Johnson Consumer Inc
Outcome results
None listed