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.
A total of 44 patients with mild to moderate Atopic Dermatitis for at least 6 months will be enrolled in the study to complete 40 patients having confirmed diagnosis of atopic dermatitis. Subjects will be called on the telephone by the recruiting department. Subjects will be pre-screened by the screening department of NovoBliss Research. Following ethics committee approval and written informed consent or assent, eligible participants underwent the protocol-specified screening assessments, including instrumental measurements and standardized photography. The subjects will be instructed to visit the facility as per the below visits. Visit 01 (Day 01): Screening, Randomization, Baseline Evaluation, Post application evaluation Visit 02 (Day 15 ±2 Days): Test products usage, Telephonic Follow-up Visit 03 (Day 30 ±2 Days): Test products usage, Evaluations. Visit 04 (Day 60 ±2 Days): Final Evaluation, End of Study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Mode 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
Mode 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
NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, India
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). improvement in DASI score will be evaluated.
Time frame: baseline before usage on Day 01 and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
To evaluate the effectiveness of the test products in terms of changes in SCORAD severity scoring,
Total SCORAD index is 103. Higher scores indicating greater severity. 0-3 description applies only to individual intensity components (0 indicates none, 1 indicates mild intensity, 2 indicates moderate intensity, and 3 indicates severe intensity). Improvement in SCORAD score
Time frame: before usage of the test products on Day 01 and after usage of test products at 30 mins on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
To evaluate the effectiveness of the test products in terms of changes in Eczema Area and Severity Index
The total maximum score for the EASI is 72. Scoring Scale indicates none (0), mild (1), moderate (2) and severe (3). 0-3 description applies only to individual signs. Improvement in EASI score will be evalauted.
Time frame: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
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). Improvement in PIHASI score.
Time frame: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin scaliness
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Scoring scale indicates 0: absent and 4: extreme. % of participants reported
Time frame: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment including roughness
Scoring scale indicates 0: absent and 4: extreme. % of participants reported
Time frame: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
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. % of participants reported
Time frame: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
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. % of participants reported
Time frame: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin dryness
Scoring scale indicates 0: absent and 4: Severe. % of participants reported
Time frame: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
To evaluate the effectiveness of the test products in terms of changes in visual and tactile assessment of skin smoothness
Scoring scale indicates 0: absent and 4: Severe. % of participants reported
Time frame: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
To evaluate the effectiveness of the test products in terms of changes in Visual Analogue Scale for Itching
Scale where 0 indicates No itching and 100 indicates most severe itching imaginable
Time frame: before usage of the test products on Day 01 and after usage of test products at 30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
To evaluate the effectiveness of the test products in terms of changes in skin hydration
Change in skin hydration (a.u.) by Corneometer CM 825
Time frame: baseline before usage and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
To evaluate the effectiveness of the test products in terms of changes in skin barrier function
Change in skin barrier function (g/m²/h) using TEWAMeter TM Hex
Time frame: before usage and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
To evaluate the effectiveness of the test products in terms of changes in skin topography
Change in skin topography (a.u.) by VISIOSCAN VC 20
Time frame: before usage and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
To evaluate the effectiveness impact of the test products in the shift of skin microbiome by collecting skin swab
Change in shift of skin microbiome by collection skin swab.
Time frame: before usage on Day 01 and after usage on Day 30 (±2 Days) and Day 60 (±2 Days)
To evaluate the effectiveness of the test products in terms of changes in product perception questionnaire
5-point Likert Scale indicates 1: Not at all and 5: to large extent
Time frame: before usage and after usage of the test products at 30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)