Safety and efficacy study of cream in subjects with mild to moderate Eczema
Completed
- Conditions
- Subjects with mild to moderate Eczema
- Registration Number
- CTRI/2021/02/031511
- Lead Sponsor
- Zydus Wellness Limited
- Brief Summary
This study is proposed to evaluate and establish the benefits of thetest product on mildness, gentleness and non-irritability on adult and baby skinand soothes the skin, also determine the experience faster relief from pain ofand keeps the skin moisturized, upon application relieving dryness, redness,oedema, urticarial and any other reactions. The proposed benefits are evaluatedby the pediatrics, subjective assessment questionnaire and instrumentalevaluation at Day 1, Day 2, Day 7 and Day 14.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess effect of test product on adult subject’s affected skin by using Eczema Area and Severity Index (EASI). 1.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days). | 2.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 3.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 4.Time 30 min (±5 mins), 1 hour (±15 mins), 2 hours (±15 mins), 4 hours (±15 mins), 8 hours (±15 mins), 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) 2.To assess effect of test product on baby’s affected skin by using Three-Item Severity (TIS). 1.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days). | 2.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 3.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 4.Time 30 min (±5 mins), 1 hour (±15 mins), 2 hours (±15 mins), 4 hours (±15 mins), 8 hours (±15 mins), 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) 4.subjective self-assessment questionnaire 1.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days). | 2.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 3.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 4.Time 30 min (±5 mins), 1 hour (±15 mins), 2 hours (±15 mins), 4 hours (±15 mins), 8 hours (±15 mins), 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) 3.To assess effect of test product on skin in terms of mildness, gentleness, non-irritability, skin erythema/ redness, dryness, itching, rashes, oedema, pruritus, urticaria 1.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days). | 2.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 3.Day 01 before application to 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days) | 4.Time 30 min (±5 mins), 1 hour (±15 mins), 2 hours (±15 mins), 4 hours (±15 mins), 8 hours (±15 mins), 12 (±2) hours, 24 (±2) hours, Day 07 (±2 Days) and Day 14 (±2 Days)
- Secondary Outcome Measures
Name Time Method 1.To assess effect of test product on adult subject’s/baby’s affected skin for erythema using Mexameter®MX 18 2.To evaluate the effect of test product on adult subject’s/baby’s affected skin pH using Skin pH meter
Trial Locations
- Locations (1)
Cliantha Research
🇮🇳Ahmadabad, GUJARAT, India
Cliantha Research🇮🇳Ahmadabad, GUJARAT, IndiaDr Nayan PatelPrincipal investigator9909013286nkpatel@cliantha.com