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Efficacy and Steroid Sparing Potential Study of DGLA Cream in Patients With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
A Prospective, Randomised, Vehicle-Controlled, Double-Blind, Exploratory Clinical Trial To Assess The Efficacy And Steroid Sparing Potential Of DGLA Cream Topically Applied To Patients With Moderate To Severe Atopic Dermatitis

Clinical Trial Summary

This study will investigate the steroid sparing potential of DS107E to vehicle in patients with moderate to severe atopic dermatitis.

DS107E or vehicle will be topically administered with a steroid twice a day for the first 7 days. For the following 28 days DS107E or vehicle will be topically administered twice a day.

This study will enrol approximately 40 adult patients.

Clinical Trial Description

Subjects will come to the clinic on 7 occasions: Screening, Baseline, Day 7, Day 14, Day 21, Day 35 (End of Treatment) and Day 42 (Follow-up). The primary efficacy variable will be EASI (Eczema Area and Severity Index). The secondary efficacy variables will be EASI, IGA (Investigators Global Assessment), SCORAD (SCORing Atopic Dermatitis), Target Lesion Score, VAS (Visual Analogue Scale), Skin Tolerability, DLQI (Dermatology Life Quality Index), Erythema, TEWL (Transepidermal Water Loss) and Time to Rescue Medication. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03676036
Study type Interventional
Source DS Biopharma
Contact
Status Completed
Phase Phase 2
Start date June 2015
Completion date July 2018
View Details
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