STS-01 for the treatment of alopecia areata

A 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 alopecia areata

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14007390

Enrollment

150

Registered

2022-03-21

Start date

2022-03-23

Completion date

Unknown

Last updated

2025-01-06

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

Conditions

Alopecia areata Skin and Connective Tissue Diseases Alopecia areata

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Alopecia areata (<50% SALT score) 2. Not currently receiving treatment for hair loss

Exclusion criteria

Exclusion criteria: Severe alopecia areata (totalis/universalis)

Design outcomes

Primary

Measure	Time frame
Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 0, 2, 4 and 6 months with a 2-month follow up	—

Secondary

Measure	Time frame
Measured at 0, 2, 4 and 6 months with a 2-month follow up 1. Regrowth area measured by graphical measuring of the size of the patch 2. AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS) and Alopecia Areata Quality of Life Index (AAQLI) 0-25 3. Global assessment using the Clinical Global Impression (CGI) score 4. Cytokines measured using assay of interleukins	—

Countries

England, Scotland, United Kingdom

Contacts

Public ContactDavid Fleet

davidfleet@manentia.co.uk+44 (0)7533002238

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026