A Phase 2 Placebo Controlled, Clinical Trial Designed to Assess the Efficacy, Safety and Dose Response Characterisation of STS01 for the Treatment of Mild-moderate Alopecia Areata (AA)
- Registration Number
- NCT06402630
- Lead Sponsor
- Soterios Ltd
- Brief Summary
A Phase 2 double-blind, multi-site, placebo-controlled, parallel-group design to assess the efficacy, safety and dose-response characterisation of STS-01 for the treatment of mild- moderate alopecia areata.
- Detailed Description
STS-01 is being developed to address the need for an effective, safe and convenient non-steroidal topical treatment for mild-moderate alopecia areata. The product builds on a mechanism with a well-established safety profile in dermatology, and existing evidence of its effectiveness in this condition through targeting key relevant cytokines. STS-01 has been modified to maximise the effectiveness of this mechanism and offer a cosmetically elegant topical cream. The study aims to assess the effectiveness, safety and dose-response characteristics of STS-01 for the treatment of mild-moderate alopecia areata.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
- Active alopecia areata (less than 50% SALT score, present for at least 6 months)
- Not currently receiving treatment for hair loss
- Eighteen years of age or more
- Affected skin with normal appearance and no grossly evident epidermal alteration such as scaling or follicular abnormalities
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1% Dose STS01 Once daily, STS-01 topical cream applied to affected area of the head Placebo Placebo Once daily, topical cream applied to affected area of the head (without API) 0.25% Dose STS01 Once daily, STS-01 topical cream applied to affected area of the head 0.5% Dose STS01 Once daily, STS-01 topical cream applied to affected area of the head 2% Dose STS01 Once daily, STS-01 topical cream applied to affected area of the head
- Primary Outcome Measures
Name Time Method Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months 6 Months Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months. Targeting patients with \<50 SALT (less than 50% hair loss).
- Secondary Outcome Measures
Name Time Method Global assessment using the Clinical Global Impression (CGI) score 6 Months Global assessment using the Clinical Global Impression (CGI) score
Regrowth area measured by graphical measuring of the size of the patch 6 months Regrowth area measured by graphical measuring of the size of the patch
AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS) 6 Months AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)
AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25 6 months AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25
Trial Locations
- Locations (9)
Queen Margaret Hospital
🇬🇧Glasgow, Dunfirmline, United Kingdom
Royal Alexandra Children's Hospital
🇬🇧Brighton, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, United Kingdom
Queen Anne Street Medical Centre Limited
🇬🇧London, United Kingdom
St Lukes Hospital
🇬🇧Bradford, Little Horton Lane, United Kingdom
University Hospital Coventry & Warwickshire
🇬🇧Coventry, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Salford Royal Hospital
🇬🇧Salford, United Kingdom