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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oculus Innovative Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01232985
First received: October 26, 2010
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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
Pruritus
Device: RD047-26
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    Investigator Global Assessment of Atopic Dermatitis Severity


Secondary Outcome Measures:
  • Investigator Pruritus Assessment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Investigator Pruritus Severity Assessment

  • Subject Itch Assessment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Subject assessment of itch severity

  • Adverse Events [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232985

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

No publications provided

Responsible Party: Oculus Innovative Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01232985     History of Changes
Other Study ID Numbers: MIC-AD-001
Study First Received: October 26, 2010
Last Updated: May 29, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 22, 2014