A CREAM CONTAINING LINOLEIC ACID, 5%DEXPANTHENOL AND CERAMIDE IN THE TREATMENT OF ATOPIC DERMATITIS

Phase 3

Completed

• Conditions: Atopic dermatitis; atopic dermatitis; linoleic acid; urea cream

• Registration Number: TCTR20200826001
• Lead Sponsor: BD HEALTHCARE CO.,LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-02-09
• Study Start: 2020-08-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

The patients, 2 to 18 years of age with diagnosis of atopic dermatitis by using UK working party’s criteria with mild and moderate diseases were included. With regard to severity grading of SCORAD score, 0-25 scores were defined as mild diseases and 26-50 scores as moderate severity.

Exclusion Criteria

The patients with active skin infection were also excluded. The patients who have committent use of tropical or systemic corticosteroids, in addition to the loss of follow up for 2 times would be excluded from this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of SCORAD score Baseline, week 2, week4 measure by modified SCORAD score,Remission of atopic dermamtits week 2, week 4 improve modified SCORAD score more than 50% from baseline

Secondary Outcome Measures

Name	Time	Method
Improvement of skin hydration baseline, week 2, week 4 Corneometer CM 825 (Courage & Khazaka Electronic GmbH, cologne, Germany). ,Patients’ satisfaction baseline, week2, week 4 Patients’ satisfaction score from 1 to 5 score grading,Adverse effect of treatment products week 2, week4 Adverse effect record form