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NCT Number: 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)

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.

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queen Margaret Hospital, Glasgow, Dunfirmline, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

STS01

Drug

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

Drug

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. Global assessment using the Clinical Global Impression (CGI) score

    Time frame: 6 Months

    Global assessment using the Clinical Global Impression (CGI) score

  3. 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)

  4. 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

Sponsors and collaborators

Lead sponsor

Soterios Ltd

Industry

Registry information

Official study 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)

Acronym: SOT01

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 7, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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