ACTRN12615000980538
Completed
Phase 1
A phase I study to investigate the pharmacokinetics, safety and tolerability of topical applied 0.25% solution of SM04554 in male subjects with androgenetic alopecia.
Samumed Pacific Pty Ltd0 sites25 target enrollmentSeptember 18, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Androgenetic alopecia (AGA)
- Sponsor
- Samumed Pacific Pty Ltd
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males with clinical diagnosis of AGA with Norwood classification score of 5, 5A, 5V or 6
- •Wiling to maintain hairstyle, use indicated shampoo \& conditioner and not use semi\-permanent hair products
- •Willing to inform female partners to avoid direct contact as potential effects to a foetus is unknown
- •Able to understand and willing to sign informed consent form
Exclusion Criteria
- •Clinical diagnosis alopecia areata or other non\-AGA forms of alopecia
- •Scalp hair loss on treatment area due to disease, injury or medical therapy
- •Current skin disease on treatment area or hands
- •History of surgical correction for hair loss on scalp and or hair transplant
- •Use of any products or devices clinically proven to promote hair loss within 24 weeks prior to Screening visit
- •Use of anti\-androgenic therapies within 12 weeks prior to Screening visit
- •Previous exposure to SM04554
- •Use of semi\-permanent hair products with 30 days prior to screening
- •Use medicated shampoo\&conditioner or OTC hair treatments of dandruff or promotion of hair growth within 30 days prior to screening
- •Current use of an occlusive wig, hair extensions or hair weaves
Outcomes
Primary Outcomes
Not specified
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