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

This study has been completed.
Information provided by (Responsible Party):
Oculus Innovative Sciences, Inc. Identifier:
First received: October 26, 2010
Last updated: May 29, 2012
Last verified: May 2012
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 Intervention Phase
Atopic Dermatitis
Device: RD047-26
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Oculus Innovative Sciences, Inc.:

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

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

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

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

Enrollment: 17
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RD047-26
Study Device
Device: RD047-26
RD047-26 emollient gel

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.

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)
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Oculus Innovative Sciences, Inc. Identifier: NCT01232985     History of Changes
Other Study ID Numbers: MIC-AD-001
Study First Received: October 26, 2010
Last Updated: May 29, 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 processed this record on May 24, 2017