NCT06687512

A Clinical Study to Assess the Safety and Effectiveness of Test Products in Mild to Moderate Atopic Dermatitis (AD) Patients.

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).

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 6 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
OTHER	SaaTwae Bio-Natural Moisturizing Cream	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
OTHER	Placebo	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

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-02-20
• Completion: 2025-02-20
• First posted: 2024-11-13
• Last updated: 2024-11-13