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, 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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06402630

Acronym

SOT01

Enrollment

158

Registered

2024-05-07

Start date

2022-03-23

Completion date

2024-04-01

Last updated

2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata

Keywords

alopecia areata, alopecia, areata, aa, autoimmune, hair loss, hair, autoimmune hair, follicle

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.

Interventions

DRUGSTS01

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.

DRUGPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026