STS-01 for the treatment of alopecia areata
| ISRCTN | ISRCTN14007390 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14007390 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2021-004145-20 |
| Integrated Research Application System (IRAS) | 304441 |
| Protocol serial number | SOT01, IRAS 304441, CPMS 50463 |
| Sponsor | Soterios Ltd |
| Funder | Soterios Ltd |
- Submission date
- 19/03/2022
- Registration date
- 21/03/2022
- Last edited
- 04/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
STS-01 is being developed to address the need for an effective, safe and convenient non-steroidal topical treatment for alopecia areata (patchy hair loss). 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 alopecia areata
Who can participate?
Patients aged over 18 years with active patchy alopecia areata who are not currently using any other hair loss medication
What does the study involve?
Participants are randomly allocated to be treated with either STS-01 or a placebo (dummy) drug. The medication is applied to the affected area daily for 6 months. Improvement is monitored at 2 monthly intervals (0, 2, 4, 6 months) by photography, a questionnaire is completed and a blood sample is taken for the assessment of inflammation.
What are the possible benefits and risks of participating?
The patient can simply apply the medication without complicated instructions for use and removal. The patient should see hair regrowth start in 4-6 weeks. The old standard STS-01 preparation was sometimes known to cause staining and irritation and although this is unlikely to happen with the new formulation it may occur in some individuals.
Where is the study run from?
Soterios Ltd (UK)
When is the study starting and how long is it expected to run for?
January 2019 to June 2024
Who is funding the study?
Soterios Ltd (UK)
Who is the main contact?
Tony Brown
TonyBrown@manentia.co.uk
Contact information
Public
Laburnum House
East Grimstead
Salisbury
SP5 3RT
United Kingdom
| Phone | +44 (0)7533002238 |
|---|---|
| davidfleet@manentia.co.uk |
Scientific
Laburnum House
East Grimstead
Salisbury
SP5 3RT
United Kingdom
| Phone | +44 (0)7533002238 |
|---|---|
| davidfleet@manentia.co.uk |
Principal investigator
Department of Infection, Immunity and Cardiovascular Disease
The University of Sheffield
Western Bank
Sheffield
S10 2TN
United Kingdom
| Phone | +44 (0)7952 926139 |
|---|---|
| a.g.messenger@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind multi-site randomized placebo-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 41391_PIS_11Oct21_V1.pdf |
| Scientific title | 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 |
| Study acronym | SOT01 |
| Study objectives | STS01 improves hair growth over placebo controls in alopecia areata (AA) patients |
| Ethics approval(s) | Approved 10/12/2021, London - South East Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8085; londonsoutheast.rec@hra.nhs.uk), ref: 21/LO/0851 |
| Health condition(s) or problem(s) studied | Alopecia areata |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | STS-01 |
| Primary outcome measure(s) |
Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 0, 2, 4 and 6 months with a 2-month follow up |
| Key secondary outcome measure(s) |
Measured at 0, 2, 4 and 6 months with a 2-month follow up |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Alopecia areata (<50% SALT score) 2. Not currently receiving treatment for hair loss |
| Key exclusion criteria | Severe alopecia areata (totalis/universalis) |
| Date of first enrolment | 23/03/2022 |
| Date of final enrolment | 23/09/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Salford
M6 8HD
United Kingdom
Bradford
BD5 0NA
United Kingdom
Brighton
BN2 5BE
United Kingdom
Dunfermline
KY12 0SU
United Kingdom
Gloucester
GL1 3NN
United Kingdom
London
W1G 8HU
United Kingdom
Glasgow
G51 4TF
United Kingdom
Norwich
NR4 7UY
United Kingdom
Coventry
CV2 2DX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version 1 | 11/10/2021 | 21/03/2022 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 41391_PIS_11Oct21_V1.pdf
- Participant information sheet
Editorial Notes
04/12/2024: The intention to publish date was changed from 31/12/2024 to 31/12/2025.
04/06/2024: The following changes were made:
1. The intention to publish date was changed from 01/06/2024 to 31/12/2024.
2. The overall study end date was changed from 01/12/2023 to 30/06/2024.
04/12/2023: The intention to publish date was changed from 01/12/2023 to 01/06/2024.
01/04/2022: Internal review.
10/03/2022: Trial's existence confirmed by the London - South East Research Ethics Committee.
