drugset / Trial / NCT03386032

8-Week Atopic Dermatitis (AD) Treatment Study

NCT03386032 ↗

Phase 3 Completed 65 enrolled Procter and Gamble
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a study to investigate the clinical effectiveness of the Sponsor's experimental cream treatment on eczema as measured by visual grading of SCORAD (scoring of atopic dermatitis).

Timeline

Start
2017-11-27
Primary completion
2018-08-18
Completion
2018-08-18

Outcome

Mixed primary results

registry MEAN Investigational OTC Cream: -12.2 (Standard Error 3.99) units on a scale NCT03386032 ↗

registry MEAN Placebo Cream: 9.3 (Standard Error 6.51) units on a scale NCT03386032 ↗

registry analysis (superiority test); Investigational OTC Cream vs Placebo Cream vs 0.05% Desonide Cream; p <0.05; ANCOVA NCT03386032 ↗

registry MEAN Investigational OTC Cream: -6.0 (Standard Error 2.8) units on a scale NCT03386032 ↗

registry MEAN Placebo Cream: -20.3 (Standard Error 3.7) units on a scale NCT03386032 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Desonide Small molecule 0.05 % Topical
Subject Investigational OTC Cream Unknown — Topical

Indications