This is an exploratory, proof-of-concept, double-blind, placebo-controlled, randomized, comparative, interventional, prospective, safety in-use tolerability and efficacy study of test products in patients with mild to moderate Atopic Dermatitis.
1) Age: For children: 6 years and above (both inclusive) at the time of parental consent/assent and For Adults: 18 to 65 years (both inclusive) at the time of consent.
1)Subjects with AD on the scalp (with hair), palms, and soles. 2) Subjects with active skin infections. 3) Subjects with other dermatologic diseases besides AD whose presence or treatments could interfere with the assessment of disease (eg, Psoriasis).
Parallel
SaaTwae Bio-Natural Moisturizing Cream
Other interventionMode of Usage: Apply a generous amount of the test product to the affected areas of atopic dermatitis. Gently massage the product into the skin until fully absorbed. Ensure that the application is consistent, especially after bathing or during flare-ups. Frequency: Twice a day (Once before going to the bed and once after bathing and drying off and during flare ups/itching) Route of Administration: Topical
Placebo
Other interventionMode of Usage: Apply a generous amount of the test product to the affected areas of atopic dermatitis. Gently massage the product into the skin until fully absorbed. Ensure that the application is consistent, especially after bathing or during flare-ups. Frequency: Twice a day (Once before going to the bed and once after bathing and drying off and during flare ups/itching) Route of Administration: Topical
To evaluate the effectiveness of the test products in terms of change in Dry Skin/Ichthyosis Area and Severity Index (DASI)
Scale indicates 0-4 categorical scale (0: absent, 1: slight, 2: moderate, 3: severe, 4: extreme)
To evaluate the effectiveness of the test products in terms of changes in SCORAD severity scoring,
Scoring scale indicates 1 indicates mild intensity, 2 indicates moderate intensity, and 3 indicates severe intensity
To evaluate the effectiveness of the test products in terms of changes in Eczema Area and Severity Index
Scoring Scale indicates none (0), mild (1), moderate (2) and severe (3).
To evaluate the effectiveness of the test products in terms of changes in visual assessment of post inflammatory hyperpigmentation
Scoring scale indicates a 0-4 categorical scale (0: absent, 1: slight, 2: mild, 3: moderate, 4: maximum)
To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin scaliness
Scoring scale indicates 0: absent and 4: extreme
To evaluate the effectiveness of the test products in terms of changes in visual and tactile
Scoring scale indicates 0: absent and 4: extreme
To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin redness
Scoring scale indicates 0: absent and 4: extreme
To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin itchiness
Scoring scale indicates 0: absent and 4: Severe
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NovoBliss Research Pvt Ltd
Lead sponsor
Blossom Microbiotics LLC
Collaborator
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