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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01232985
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : May 30, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Pruritus Device: RD047-26 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching
U.S. FDA Resources

Arm Intervention/treatment
Experimental: RD047-26
Study Device
Device: RD047-26
RD047-26 emollient gel

Primary Outcome Measures :
  1. Investigator Global Assessment [ Time Frame: 2 weeks ]
    Investigator Global Assessment of Atopic Dermatitis Severity

Secondary Outcome Measures :
  1. Investigator Pruritus Assessment [ Time Frame: 2 weeks ]
    Investigator Pruritus Severity Assessment

  2. Subject Itch Assessment [ Time Frame: 2 weeks ]
    Subject assessment of itch severity

  3. Adverse Events [ Time Frame: 2 weeks ]
    Number of subjects with related adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01232985

United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Oculus Innovative Sciences, Inc.
Principal Investigator: Zoe Draelos, M.D. Dermatology Consulting Services, High Point NC

Responsible Party: Oculus Innovative Sciences, Inc. Identifier: NCT01232985     History of Changes
Other Study ID Numbers: MIC-AD-001
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Oculus Innovative Sciences, Inc.:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Skin Manifestations
Signs and Symptoms