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) (SOT01)

May 3, 2024 updated by: Soterios Ltd

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Royal Alexandra Children's Hospital
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry & Warwickshire
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
      • Gloucester, United Kingdom, GL1 3NN
        • Gloucestershire Royal Hospital
      • London, United Kingdom, W1G 8HU
        • Queen Anne Street Medical Centre Limited
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Salford, United Kingdom, M6 8HD
        • Salford Royal Hospital
    • Dunfirmline
      • Glasgow, Dunfirmline, United Kingdom, KY12 0SU
        • Queen Margaret Hospital
    • Little Horton Lane
      • Bradford, Little Horton Lane, United Kingdom, BD5 0NA
        • St Lukes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.25% Dose
Once daily, STS-01 topical cream applied to affected area of the head
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.
Experimental: 0.5% Dose
Once daily, STS-01 topical cream applied to affected area of the head
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.
Experimental: 1% Dose
Once daily, STS-01 topical cream applied to affected area of the head
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.
Experimental: 2% Dose
Once daily, STS-01 topical cream applied to affected area of the head
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 Comparator: Placebo
Once daily, topical cream applied to affected area of the head (without API)
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regrowth area measured by graphical measuring of the size of the patch
Time Frame: 6 months
Regrowth area measured by graphical measuring of the size of the patch
6 months
Global assessment using the Clinical Global Impression (CGI) score
Time Frame: 6 Months
Global assessment using the Clinical Global Impression (CGI) score
6 Months
AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)
Time Frame: 6 Months
AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)
6 Months
AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25
Time Frame: 6 months
AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soterios Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2022

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOT01
  • 2021-004145-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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