A patch test study of STS01 in healthy volunteers

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: Participants are randomised to a patch test of STS01 topical cream in strengths of 0.0%, 0.25%, 0.5%, 1% and 2% w/w or a control treatment (E45 Dermatological Cream); applied once. CONDITION: Healthy volunteer study ‐ the treatment is for alopecia areata ; Skin and Connective Tissue Diseases ; Alopecia areata PRIMARY OUTCOME: Assessment of test product contact with the skin using appropriate ranking scales, chromameter measurements and thermometry measurements. Staining of the application area will also be assessed by imaging (camera or TiVi Imaging System). Cream application sites will be assessed after a minimum of 10 minutes and a maximum of 30 minutes to allow any reactions due to the removal of the tape and test chamber to subside. The test chambers will be removed and assessed at 1, 2, 4 and 8 hours. SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: 1. Subjects who are in the age range 18 – 70 years 2. Subjects with no significant concurrent illnesses or skin disease 3. Subjects who have signed the consent form after the nature of the study has been fully explained
Epistemonikos ID: 46e7e0c5c022fbbd8d3d707ea9cf48b012c0dfef
First added on: Aug 26, 2024