None listed
Conditions
Interventions
Intervention1: Cream: Manufactured by: SETHIC
Mode of Application: Apply a thin, uniform layer of the cream over clean and dry skin, ensuring complete coverage of the affected region. The cream shoul
Sponsors
Sethic
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 0 to 12 years at the time of parenteral consent. 2) Sex: Boys and Girls. 3) Participants are generally in good health. 4) Participants aged 0 3 years (Cohort A) with a history of dry and/or sensitive skin, eczema-prone skin, or atopic tendency (based on family history and/or prior physician diagnosis), as confirmed by the investigator, no significant acute flare required. 5) Participants aged 4 12 years (Cohort B) with mild to moderate eczema, defined as an Eczema Area and Severity Index (EASI) score between 3 and 16 and a SCORing Atopic Dermatitis (SCORAD) score between 15 and 40, as determined at screening, and having target areas suitable for clinical and instrumental assessments, will be enrolled in the study. 6) Participants are not allowed to participate in any other study until this study is complete. 7) Written parental consent form from Parent(s)/legal guardian and written assent from the participant, as applicable. 8) Participants and child s legal parent or guardian must agree to record each use of the test treatment in the participant s diary card on daily basis. 9) Participants and child s legal parent or guardian who are willing to complete all study procedures including study-related questionnaires and comply with study requirements. 10) Participants and child s legal parent or guardian must agree to use the same brands and agree not to switch brands or variants of any skin care products during the study period. 11) Participants and child s legal parent or guardian must agree to limit the sun exposure to affected areas such as arms, legs covered during prolonged sun exposure. 12) Participants and child s legal parent or guardian must agree to dress the participants in loose clothing to allow easy exposure to the entire body during study visits and throughout study duration of 60 days.
Exclusion criteria
Exclusion criteria: 1) Participants with severe atopic dermatitis, defined as requiring systemic therapy. 2) Presence of active skin infection (bacterial, viral, or fungal) requiring medical treatment at baseline. 3) Use of the following treatments within the specified washout periods prior to baseline: - Topical corticosteroids or calcineurin inhibitors applied to the assessment areas within 7 days prior to baseline. - Systemic therapies, including corticosteroids, Janus kinase (JAK) inhibitors, or biologics, within 8 weeks prior to baseline (or 5 half-lives, whichever is longer). - Phototherapy within 4 weeks prior to baseline. 4) The participant has a known allergy or sensitivity to treatment ingredients. 5) History of other significant dermatological, autoimmune disease, malignancy or other systemic diseases that may interfere with study participation or data interpretation. 6) History of chronic illness which may influence the cutaneous state.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the in-use safety and local tolerability of test treatments in babies with eczema-prone skin and children with mild-to-moderate atopic dermatitis. To evaluate the effectiveness of the test treatments such as Temperature, Pulse Rate, Respiratory rate, forehead temperature by assessing changes in vital signs.Timepoint: From baseline before treatment usage on Day 01 and after usage of the test treatment at T20 mins, Day 15 ( 2 Days), Day 29 ( 2 Days) and Day 57 ( 2 Days). From baseline before treatment usage on Day 01 and after usage of the test treatment at T20 mins, Day 15 ( 2 Days), Day 29 ( 2 Days) and Day 57 ( 2 Days). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test treatments in Children with mild to moderate eczema (Cohort B) by assessing disease severity using Eczema Area and Severity Index (EASI), SCORAD, validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD ), Body Surface Area (BSA) and Faces Pain Scale Revised Babies with eczema prone skin (Cohort A) by assessing changes in disease severity using validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD ). Timepoint: From baseline before treatment usage on Day 01 and after usage of the test treatment at T20 mins, Day 15 ( 2 Days), Day 29 ( 2 Days) and Day 57 ( 2 Days).;To evaluate the effectiveness of the test treatments in babies with eczema prone skin (Cohort A) by assessing changes in dryness severity from baseline to post-treatments usage, within each treatment group and across treatment groups.Timepoint: From baseline before treatment usage on Day 01 and after usage of the test treatment at T20 mins, Day 15 ( 2 Days), Day 29 ( 2 Days) and Day 57 ( 2 Days).;To evaluate the effectiveness of the test treatments in children with mild to moderate eczema (Cohort B) and in children with eczema prone skin (Cohort A) by assessing changes in pruritus using VASTimepoint: From baseline before treatment usage on Day 01 and after usage of the test treatment at T20 mins, Day 15 ( 2 Days), Day 29 ( 2 Days) and Day 57 ( 2 Days).;To evaluate the effectiveness of the test treatments in babies with mild to moderate eczema by assessing change in sleep disturbance from baseline to post-treatments usage, within each treatment group and across treatment groups.Timepoint: From baseline before treatment usage on Day 01 and after usage of the test treatment at T20 mins, Day 15 ( 2 Days), Day 29 ( 2 Days) and Day 57 ( 2 Days).;To evaluate the effectiveness of the test treatments by assessing change in skin hydration from baseline to post-treatments usage, within each treatment group and across treatment grou | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
Outcome results
None listed