None listed
Conditions
Interventions
Intervention1: Cetaphil Restoraderm Skin Restoring Body Wash: Subjects will be instructed to use the cleanser once a day in the morning for 4 weeks. Apply to wet skin, massage into a lather and rinse
Sponsors
MS Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Prospective adult subjects who have mild to moderate atopic dermatitis as determined on SCORAD by dermatologist evaluation and having dry skin concern, evaluated with Corneometer reading less than 30 at the screening visit. 2. Subjects who have not used Class I-III topical steroid in the last 4 weeks prior to baseline visit can be included in the study. 3. In case of subjects who have used Class I-III topical steroid in the last 4 weeks prior to baseline visit, and are stable on it, and continue to remain stable after discontinuing topical steroid for 4 weeks prior to baseline visit. Such subjects should additionally refrain from using TCS during the course of the study 4. Subjects who present with a SCORAD score of 15 and 35 at the baseline visit will be deemed eligible for the study.
Exclusion criteria
Exclusion criteria: 1. Scarring, tattoos or any other skin reaction that may impact the result. 2. Having been diagnosed with known allergies to facial or body skin care products. 3. Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report. 4. Having a history of skin cancer within the past 5 years. 4. Having used systemic steroid in the last 1 week and not agree to undergo a wash out period of at least 2 weeks or wish to take systemic steroids during the course of the study period 5. Having used skin moisturizing products to treat eczema in the 3 days before the screening visit. 6. Having used oral isotretinoin within 6 months. Have undergone phototherapy in the last 4 weeks 7. Have used retinoids on the test area in the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in skin hydration using Corneometer CM 825 at T1, Week 2 and Week 4 as compared to baseline. 2. Improvement in Trans-epidermal water loss using Tewameter TM 300 at Week 2 and Week 4 as compared to baseline.Timepoint: T1, week 2 and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in Trans-epidermal water loss using Tewameter TM 300 at T1 as compared to baseline. 2. Clinical Improvement in SCORAD graded by Dermatologist at Week 2 and Week 4 as compared to baseline. 3. Improvement in Patient-oriented SCORAD evaluation (PO-SCORAD) at Week 2 and Week 4 as compared to baseline. 4. Change in pH values using Skin pH meter PH 905 at Week 2 and Week 4 as compared to baseline. 5. Improvement in skin surface evaluation using Visioscan VC20 plus at Week 2 and Week 4 as compared to baseline. 6. Safety/Tolerability Evaluation for intolerance, Adverse effects and other reactions at T1, Week 2 and Week 4. 7. Subject Self-Assessment - Self-perceived improvement- Questionnaire at Week 2 and Week 4 as compared to baseline.Timepoint: T1, week 2 and week 4 | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd.
Outcome results
None listed