| CTRI Number |
CTRI/2025/06/088456 [Registered on: 09/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check if Cetaphil Restoraderm cleanser and moisturizer improve skin hydration in subjects having mild to moderate atopic dermatitis. |
|
Scientific Title of Study
|
A monocentric baseline controlled, prospective clinical study to evaluate the efficacy of test product regimen [Cetaphil Restoraderm cleanser & moisturizer] in improving hydration and managing mild to moderate atopic dermatitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/GDAD/2025-01 version 1.0 dated 22 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
327/15, 1st Main Road
1st Main Road
Cambridge Layout,
Ulsoor,
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara Kumari |
| Designation |
Director- Business and Operations |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
Room 1, Ground floor
327/15, 1st Main Road
1st Main Road
Cambridge Layout,
Ulsoor,
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Manager- Techno Commercial |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
#324, Second Floor, Room no 1, 1st Main Road, Cambridge Layout, Ulsoor,
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Galderma India Private Limited
33rd floor, Commerz III International Business
Park, Oberoi Garden City, Off Western Express
Highway, Goregaon East, Mumbai - 400063 |
|
|
Primary Sponsor
|
| Name |
MS Clinical Research Pvt Ltd |
| Address |
327/15, 1st Main Road
Cambridge Layout,
Ulsoor, Bangalore-560008, Karnataka, India. |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukta Sachdev |
MS Clinical Research Pvt. Ltd. |
Department of Skin Sciences,
#324, Second Floor,
1st Main Road, Cambridge Layout,
Ulsoor,
Bangalore
KARNATAKA |
080 40917253
mukta.sachdev@msclinical.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independant Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Atopic dermatitis (AD) subjects with mild to moderate active AD with SCORAD score of 15–35. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cetaphil Restoraderm Skin Restoring Body Moisturizer |
Subjects will be instructed to use the moisturizer twice a day (morning and night) for 4 weeks. To be used after the use of cleanser on dry and affected regions and massaged gently until fully absorbed by the skin. |
| Intervention |
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 with lukewarm water and pat dry with a soft towel.
In the evening, subjects will be instructed to rinse the extremities with water and apply Restoraderm body wash if required. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
T1, week 2 and week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
T1, week 2 and week 4 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Atopic dermatitis (AD) is characterized by dry skin. The condition involves a compromised skin barrier, which leads to increased transepidermal water loss and reduced ability to retain moisture. Managing dryness through effective moisturization and gentle cleansing is a cornerstone of treatment to help restore the skin barrier and alleviate symptoms. This study aims at evaluation of Cleanser and Moisturizer regimen in improve skin moisturization and providing relief or maintenance of AD skin conditions.
Efficacy of the test regime in improving skin hydration will be evaluated using dermatological assessments, corneometer, tewameter, visioscan, skin pH meter, self-assessment questionnaires at baseline, T1, week 2 and week 4. |