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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
158
Participants are block randomised to be treated with 0.25%, 0.5%, 1.0%, 2% STS-01 or a matching placebo control topically once daily for 6 months with a 2-month follow up.
Participants are block randomised to be treated with 0.25%, 0.5%, 1.0%, 2% STS-01 or a matching placebo control topically once daily for 6 months with a 2-month follow up.
Queen Margaret Hospital
Glasgow, Dunfirmline, United Kingdom
St Lukes Hospital
Bradford, Little Horton Lane, United Kingdom
Royal Alexandra Children's Hospital
Brighton, United Kingdom
University Hospital Coventry & Warwickshire
Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 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).
Time frame: 6 Months
Regrowth area measured by graphical measuring of the size of the patch
Regrowth area measured by graphical measuring of the size of the patch
Time frame: 6 months
Global assessment using the Clinical Global Impression (CGI) score
Global assessment using the Clinical Global Impression (CGI) score
Time frame: 6 Months
AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)
AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)
Time frame: 6 Months
AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25
AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Coventry, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Gloucestershire Royal Hospital
Gloucester, United Kingdom
Queen Anne Street Medical Centre Limited
London, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Salford Royal Hospital
Salford, United Kingdom