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

Atopic Dermatitis Clinical Trial

Official title:

An Open-Label Pilot Study to Determine the Efficacy and Tolerability of a Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis With Associated Pruritus in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232985
• Other study ID #: MIC-AD-001
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2010
• Last updated: May 29, 2012
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2012
• Source: Oculus Innovative Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Pruritus

Intervention

Device:
• RD047-26
RD047-26 emollient gel

Locations

Country	Name	City	State
United States	Dermatology Consulting Services	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Oculus Innovative Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Global Assessment	Investigator Global Assessment of Atopic Dermatitis Severity	2 weeks	No
Secondary	Investigator Pruritus Assessment	Investigator Pruritus Severity Assessment	2 weeks	No
Secondary	Subject Itch Assessment	Subject assessment of itch severity	2 weeks	No
Secondary	Adverse Events	Number of subjects with related adverse events	2 weeks	No