Clinical trial NCT06402630: 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)
Official title: A Phase 2 Double-blind, Multicentre, Placebo Controlled, Parallel Group Design to Assess the Efficacy, Safety and Dose Response Characterisation of STS01 for the Treatment of Mild-moderate Alopecia Areata (AA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: alopecia areata
alopecia
areata
aa
autoimmune
hair loss
hair
autoimmune hair
follicle
Lead sponsor: Soterios Ltd
Sponsor class: INDUSTRY
First posted: 2024-05-07
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Active alopecia areata (less than 50% SALT score, present for at least 6 months)
2. Not currently receiving treatment for hair loss
3. Eighteen years of age or more
4. Affected skin with normal appearance and no grossly evident epidermal alteration such as scaling or follicular abnormalities

Primary outcomes:
measure: Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months
timeFrame: 6 Months
Secondary outcomes:
measure: Regrowth area measured by graphical measuring of the size of the patch
timeFrame: 6 months
measure: Global assessment using the Clinical Global Impression (CGI) score
timeFrame: 6 Months
measure: AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)
timeFrame: 6 Months
measure: AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25
timeFrame: 6 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Margaret Hospital
state: Dunfirmline
city: Bradford
country: United Kingdom
facility: St Lukes Hospital
state: Little Horton Lane
city: Brighton
country: United Kingdom
facility: Royal Alexandra Children's Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry & Warwickshire
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: London
country: United Kingdom
facility: Queen Anne Street Medical Centre Limited
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
Study officials:
References: