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Hexarelin

Examorelin, HEX

Quick Stats
Studies 233
Trials 61
Not Yet Recruiting NA INTERVENTIONAL NCT06687512

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: To evaluate the effectiveness of the test products in terms of change in Dry Skin/Ichthyosis Area and Severity Index (DASI)
TimeFrame: 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)
Description: Scale indicates 0-4 categorical scale (0: absent, 1: slight, 2: moderate, 3: severe, 4: extreme)
Measure: To evaluate the effectiveness of the test products in terms of changes in SCORAD severity scoring,
TimeFrame: 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).
Description: Scoring scale indicates 1 indicates mild intensity, 2 indicates moderate intensity, and 3 indicates severe intensity
Measure: To evaluate the effectiveness of the test products in terms of changes in Eczema Area and Severity Index
TimeFrame: 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).
Description: Scoring Scale indicates none (0), mild (1), moderate (2) and severe (3).
Measure: To evaluate the effectiveness of the test products in terms of changes in visual assessment of post inflammatory hyperpigmentation
TimeFrame: 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).
Description: Scoring scale indicates a 0-4 categorical scale (0: absent, 1: slight, 2: mild, 3: moderate, 4: maximum)

Trial Information

NCT ID

NCT06687512

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

NovoBliss Research Pvt Ltd

Last Updated

December 15, 2025