SAFETY AND EFFECTIVENESS OF OXYRESVERATROL CREAM IN HEALTHY VOLUNTEERS AND PATIENT WITH DERMATITIS

Phase 3

Recruiting

• Conditions: patients with dermatitis; Oxyresveratrol, Dermatitis, Eczema

• Registration Number: TCTR20240611001
• Lead Sponsor: Ratchadapisek Research Fund - Type 2

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-11
• Last Update Posted: 19 August 2024
• Study Completion: 2025-01-17

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Diagnosis with acute to subacute eczema by dermatologist at OPD King Chulalongkorn Memorial hospital 2. At least 1 lesion of acute to subacute eczema with mild severity with 0-12 Eczema Area and Severity Index score

Exclusion Criteria

1. wide-spread systemic skin diseases 2. other skin lesion at the area of study 3. history of ORV allergy 4. pregnant or lactation 5. received topical immunosuppressant or corticosteroid within 2 weeks 6. received oral immunosuppressant or corticosteroid within 4 weeks 7. received live vaccine or immunotherapy within 4 weeks 8. patients with cancer or autoimmune disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eczema Area and Severity Index (EASI) baseline, 3 days, 7 days, 14 days, and 28 days (range from 0 to 72)

Secondary Outcome Measures

Name	Time	Method
Biophysical changes of skin (skin hydration, trans-epidermal water loss, pH) baseline, 3 days, 7 days, 14 days, and 28 days using Corneometer (unit from 0 (no water at all) - 120 (on water)), Tewameter (g/m2/h), and pH meter(a scale of 0 to 14)