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)
NCT ID: NCT06402630
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
158 participants
INTERVENTIONAL
2022-03-23
2024-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.25% Dose
Once daily, STS-01 topical cream applied to affected area of the head
STS01
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.
0.5% Dose
Once daily, STS-01 topical cream applied to affected area of the head
STS01
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.
1% Dose
Once daily, STS-01 topical cream applied to affected area of the head
STS01
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.
2% Dose
Once daily, STS-01 topical cream applied to affected area of the head
STS01
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
Once daily, topical cream applied to affected area of the head (without API)
Placebo
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.
Interventions
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STS01
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
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 Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Soterios Ltd
INDUSTRY
Responsible Party
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Locations
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Queen Margaret Hospital
Glasgow, Dunfirmline, United Kingdom
St Lukes Hospital
Bradford, Little Horton Lane, United Kingdom
Royal Alexandra Children's Hospital
Brighton, , United Kingdom
University Hospital Coventry & Warwickshire
Coventry, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Queen Anne Street Medical Centre Limited
London, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Countries
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Other Identifiers
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2021-004145-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SOT01
Identifier Type: -
Identifier Source: org_study_id
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