MedTrace Logo

8-Week Atopic Dermatitis (AD) Treatment Study

NCT03386032 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-12-17

Study results available
· View outcomes & findings →

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).

Conditions

  • Atopic Dermatitis Eczema

Interventions

DRUG

Investigational OTC Cream

Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.

DRUG

0.05% Desonide

Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions. Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.

OTHER

Placebo Cream

Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Amanda Salisbury, BSN · Wake Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2018-08-18
Completion
2018-08-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386032 on ClinicalTrials.gov