TCS: BD application in Week 1, thereafter need to use basis Emollient Cream: BD for the entire duration of the study for 6 weeks.
Total duration of the study is 6 weeks.
TCS: BD application in Week 1, thereafter need to use basis
Moisturizing Cream: BD for the entire duration of the study for 6 weeks.
Duration of study is 6 weeks.
Inclusion Criteria
Age From
2.00 Month(s)
Age To
55.00 Year(s)
Gender
Both
Details
1.Female or male, 2 months to 55 years of age, of local population at each testing site, with the following subgroups per cell:
· Child subgroup: 2 months to 17 years (with approximately 50% of subjects ≤9 years of age per cell, and every effort will be made to enroll at least 1 subject age 1 year or younger per site and for enrolled subjects to be aged 2 months to 11 years of age)
· Adult subgroup: 18 to 55 years
2. In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
3. Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type).
4. Having at least 1 active atopic dermatitis (AD) lesion of mild to moderate severity on the arms, legs, or torso (not on the hands, feet, face, or neck) at baseline, as determined by the Dermatologist.
5. Willing to stop using on the body any medication or skin moisturizing treatment products (including sunscreen with moisturizer) for atopic dermatitis other than the provided test material, and willing to use the provided study materials instead as directed during the study.
6. Willing to have the skin assessed on the arms, legs, and torso.
7. Willing to not shave the test area (on the arms, legs, or torso) within 3 days of each study visit and willing to have body hair trimmed with scissors by clinic personnel during a clinic visit if needed for better visibility of the AD lesion.
8. Willing to have digital images taken of the dermatologist-selected lesion on the arms, legs, and torso.
9. Willing to provide written informed consent and able to read, speak, write, and understand any of the local languages in which the ICF is available (Hindi)
10. Willing to sign a photography release.
11. Willing to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, AE symptoms, or reactions immediately.
Clinical Grading (SCORAD) by the study dermatologist at baseline and weeks 1, 4 and 6
weeks 1, 4 and 6
Secondary Outcome
Outcome
TimePoints
Subject reporting of Subjective Irritation Parameters at baseline and weeks 1, 4 and 6
Monitoring of adverse events (AEs) throughout the course of the study
weeks 1, 4 and 6
Target Sample Size
Total Sample Size="40" Sample Size from India="40" 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)
31/01/2025
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="4" 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 a chronic condition characterized by dryness, itchiness, and inflammation, often managed with topical corticosteroids (TCS). Prolonged TCS use poses risks, necessitating complementary approaches to enhance treatment outcomes and reduce reliance on TCS.
This double-blind, randomized, controlled cosmetic clinical trial aims to assess and compare the effects of the marketed moisturizing cream versus a comparator cream over 6 weeks. The study includes adults (18 to 55 years) and children (2 months to17 years) with at least one active mild-to-moderate AD lesion on the body (arms, legs, or torso). Participants apply a provided TCS for 7 to 14 days and as needed thereafter.
The study evaluates whether adjunctive use of moisturizers improves skin hydration, relieves dryness and itching, enhances AD management, and reduces long-term TCS usage, offering a safer, more effective approach to symptom relief.