Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults

Phase 2

Completed

• Conditions: Atopic Dermatitis; Pruritus
• Interventions: Device: RD047-26

• Registration Number: NCT01232985
• Lead Sponsor: Oculus Innovative Sciences, Inc.

Brief Summary

The purpose of this study is to find out if investigational device, RD047-26, is safe and useful for the treatment of mild to moderate atopic dermatitis.

Detailed Description

RD047-26, a device, may be tolerable and effective for the treatment of mild to moderate atopic dermatitis with associated pruritus in adults. The treatment effect will be evaluated by the subject and investigator.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-29
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Written informed consent
• Female or male, 18 to 65 years of age and in good general health
• Clinical diagnosis of stable mild to moderate atopic dermatitis
• Willing and able to follow study instructions and likely to complete all study requirements

Exclusion Criteria

• Severe or uncontrolled asthma
• Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of birth control
• Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RD047-26	RD047-26	Study Device

Primary Outcome Measures

Name	Time	Method
Investigator Global Assessment	2 weeks	Investigator Global Assessment of Atopic Dermatitis Severity

Secondary Outcome Measures

Name	Time	Method
Investigator Pruritus Assessment	2 weeks	Investigator Pruritus Severity Assessment
Subject Itch Assessment	2 weeks	Subject assessment of itch severity
Adverse Events	2 weeks	Number of subjects with related adverse events

Trial Locations

Locations (1)

Dermatology Consulting Services; 🇺🇸 High Point, North Carolina, United States