NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, 382481, India
NCT Number: NCT06687512
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.
Looking for future studies?
Notify Me6 year–65 year
All sexes
Interventional
Not applicable
Ahmedabad, Gujarat, 382481, India
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 pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department.
A sufficient number of patients and children patients with legal parent or legal guardian will be pre-screened based on the moisture level by Corneometer® CM 825 and trans epidermal water loss by TEWAMeter® TM Hex followed by photographic collection of the active site for atopic dermatitis to ensure that enough subjects successfully qualify for screening before EC approval. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: baseline before usage on Day 01 and after usage of the test products at T30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
Scale indicates 0-4 categorical scale (0: absent, 1: slight, 2: moderate, 3: severe, 4: extreme)
Time frame: before usage of the test products on Day 01 and after usage of test products at T30 mins on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
Scoring scale indicates 1 indicates mild intensity, 2 indicates moderate intensity, and 3 indicates severe intensity
Time frame: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
Scoring Scale indicates none (0), mild (1), moderate (2) and severe (3).
Time frame: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
Scoring scale indicates a 0-4 categorical scale (0: absent, 1: slight, 2: mild, 3: moderate, 4: maximum)
Time frame: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
Scoring scale indicates 0: absent and 4: extreme
Time frame: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
Scoring scale indicates 0: absent and 4: extreme
Time frame: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
Scoring scale indicates 0: absent and 4: extreme
Time frame: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
Scoring scale indicates 0: absent and 4: Severe
Time frame: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
Scoring scale indicates 0: absent and 4: Severe
Time frame: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
Scoring scale indicates 0: absent and 4: Severe
Time frame: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
Scale where 0 indicates No itching and 100 indicates most severe itching imaginable
Time frame: baseline before usage and after usage of the test products at T30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
Change in skin hydration by Corneometer CM 825
Time frame: before usage and after usage of the test products at T30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
Change in skin barrier function using TEWAMeter TM Hex
Time frame: before usage and after usage of the test products at T30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
Change in skin topography by VISIOSCAN VC 20
Time frame: before usage and after usage of the test products at T30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
Change in shift of skin microbiome by collection skin swab.
Time frame: before usage and after usage of the test products at T30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
Questionnaire scale indicates 1: Not at all and 5: to large extent
NovoBliss Research Pvt Ltd
Other
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 (AD).
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05613062
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Hong Kong
View Trial DetailsNCT05633355
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Phoenix, Arizona, United States
View Trial DetailsNCT05899816
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Scottsdale, Arizona, United States
View Trial DetailsNCT05398445
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Birmingham, Alabama, United States
View Trial Details