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NCT06402630 Clinical Trial

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)

Alopecia Areata Clinical Trial

— SOT01  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06402630
Other study ID # SOT01
Secondary ID 2021-004145-20
Status Completed
Phase Phase 2
First received
Last updated
Start date March 23, 2022
Est. completion date April 1, 2024

Study information
Verified date May 2024
Source Soterios Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 158
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• STS01
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.
• Placebo
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.

Locations
Country Name City State
United Kingdom St Lukes Hospital Bradford Little Horton Lane
United Kingdom Royal Alexandra Children's Hospital Brighton
United Kingdom University Hospital Coventry & Warwickshire Coventry
United Kingdom Queen Elizabeth University Hospital Glasgow
United Kingdom Queen Margaret Hospital Glasgow Dunfirmline
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

Sponsors (1)
Lead Sponsor Collaborator
Soterios Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 6 Months
Secondary Regrowth area measured by graphical measuring of the size of the patch Regrowth area measured by graphical measuring of the size of the patch 6 months
Secondary Global assessment using the Clinical Global Impression (CGI) score Global assessment using the Clinical Global Impression (CGI) score 6 Months
Secondary 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) 6 Months
Secondary 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 6 months
See also
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Completed NCT02812342 - Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants Phase 2
Completed NCT02350023 - Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata Phase 4
Completed NCT02018042 - An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata Phase 2
Terminated NCT01898806 - Intralesional Steroids in the Treatment of Alopecia Areata Phase 4
Recruiting NCT04011748 - Clinical Application of Stem Cell Educator Therapy in Alopecia Areata Phase 2
Terminated NCT04517864 - PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA Phase 2
Not yet recruiting NCT05803070 - Topical Cetirizine in Treatment of Localized Alopecia Areata
Not yet recruiting NCT05496426 - A Study of KL130008 in Adults With Severe Alopecia Areata Phase 2
Completed NCT04147845 - Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata N/A
Terminated NCT03325296 - Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata. Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Enrolling by invitation NCT05745389 - CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2
Not yet recruiting NCT06087796 - Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata. Phase 1
Withdrawn NCT03532958 - Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata Phase 2
Recruiting NCT02604888 - Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females N/A
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Completed NCT00408798 - Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin N/A