A patch test study of STS01 in healthy volunteers

Not Applicable

Completed

• Conditions: Healthy volunteer study - the treatment is for alopecia areata; Skin and Connective Tissue Diseases; Alopecia areata

• Registration Number: ISRCTN84166928
• Lead Sponsor: Soterios Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-08
• Study Completion: 2022-12-31
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 158

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified