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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004145-20 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25% Dose | Experimental | Once daily, STS-01 topical cream applied to affected area of the head |
|
| 0.5% Dose | Experimental | Once daily, STS-01 topical cream applied to affected area of the head |
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| 1% Dose | Experimental | Once daily, STS-01 topical cream applied to affected area of the head |
|
| 2% Dose | Experimental | Once daily, STS-01 topical cream applied to affected area of the head |
|
| Placebo | Placebo Comparator | Once daily, topical cream applied to affected area of the head (without API) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STS01 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 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). | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Regrowth area measured by graphical measuring of the size of the patch | Regrowth area measured by graphical measuring of the size of the patch | 6 months |
| Global assessment using the Clinical Global Impression (CGI) score |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Margaret Hospital | Glasgow | Dunfirmline | KY12 0SU | United Kingdom | ||
| St Lukes Hospital |
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| Placebo | Drug | 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. |
|
Global assessment using the Clinical Global Impression (CGI) score
| 6 Months |
| AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS) | AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS) | 6 Months |
| AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25 | AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25 | 6 months |
| Bradford |
| Little Horton Lane |
| BD5 0NA |
| United Kingdom |
| Royal Alexandra Children's Hospital | Brighton | BN2 5BE | United Kingdom |
| University Hospital Coventry & Warwickshire | Coventry | CV2 2DX | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| Gloucestershire Royal Hospital | Gloucester | GL1 3NN | United Kingdom |
| Queen Anne Street Medical Centre Limited | London | W1G 8HU | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | NR4 7UY | United Kingdom |
| Salford Royal Hospital | Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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