Healthy volunteer study - the treatment is for alopecia areata Skin and Connective Tissue Diseases Alopecia areata
Conditions
Interventions
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.
Sponsors
Soterios Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding or lactating females or females who have given birth in the last 6 weeks 2. Subjects with a diagnosis of psoriasis, even if disease is not currently active 3. Subjects who participated in the safety phase and had dithranol formulations applied to the skin may not participate in the repeated phase 4. Subjects with atopy, self-diagnosed sensitive skin, or other dermatoses 5. Subjects who take any systemic or topical medication likely to interfere with the study e.g., anti-inflammatory drugs such as systemic steroids 6. Subjects who have taken part in a Health Research Authority or MHRA regulated clinical trial (e.g., at a hospital or Phase I unit) within the previous 8 weeks 7. Subjects who have taken part in a study involving the test site during the previous 4 weeks 8. Subjects with a recent history (previous 12 months) of significant skin disease requiring medical intervention, e.g., Dermatology outpatient appointment 9. Subjects with an allergy likely to interfere with the study 10. Subjects with a recent history of/or evidence of alcohol, substance or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
United Kingdom, Wales
Outcome results
None listed