STS-01 for the treatment of alopecia areata

ISRCTN	ISRCTN14007390
DOI	https://doi.org/10.1186/ISRCTN14007390
EudraCT/CTIS number	2021-004145-20
IRAS number	304441
Secondary identifying numbers	SOT01, IRAS 304441, CPMS 50463

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Study website

Contact information

Mr David Fleet
Public

Laburnum House
East Grimstead
Salisbury
SP5 3RT
United Kingdom

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

Mr David Fleet
Scientific

Laburnum House
East Grimstead
Salisbury
SP5 3RT
United Kingdom

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

Prof Andrew Messenger
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
Email	a.g.messenger@sheffield.ac.uk

Study information

Study design	Double-blind multi-site randomized placebo-controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	STS-01
Primary outcome measure	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 outcome measures	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
Overall study start date	01/01/2019
Completion date	30/06/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
Scotland
United Kingdom

Study participating centres

Salford Royal Hospital

Stott Lane Eccles
Salford
M6 8HD
United Kingdom

St Lukes Hospital

Little Horton Lane
Bradford
BD5 0NA
United Kingdom

Royal Alexandra Children's Hospital

Eastern Road
Brighton
BN2 5BE
United Kingdom

Queen Margaret Hospital

Whitefield Road
Dunfermline
KY12 0SU
United Kingdom

Gloucestershire Royal Hospital

Great Western Road
Gloucester
GL1 3NN
United Kingdom

Queen Anne Street Medical Centre Limited

18-22 Queen Anne Street
London
W1G 8HU
United Kingdom

Queen Elizabeth University Hospital

1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Norfolk and Norwich University Hospital

Colney Lane Colney
Norwich
NR4 7UY
United Kingdom

University Hospital Coventry & Warwickshire

Clifford Bridge Road Walsgrave
Coventry
CV2 2DX
United Kingdom

Sponsor information

Soterios Ltd
Industry

Laburnum House
East Grimstead
Salisbury
SP5 3RT
England
United Kingdom

Phone	+44 (0)7533002238
Email	info@soteriospharma.com
Website	https://www.soteriospharma.com

Funders

Funder type

Industry

Soterios Ltd

No information available

Results and Publications

Intention to publish date	31/12/2025
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
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?
Participant information sheet	version 1	11/10/2021	21/03/2022	No	Yes
HRA research summary			28/06/2023	No	No

Additional files

41391_PIS_11Oct21_V1.pdf

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.