Back to resultsEfficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults
Primary Purpose
Atopic Dermatitis, Pruritus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RD047-26
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Pruritus
Eligibility 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)
Sites / Locations
- Dermatology Consulting Services
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RD047-26
Arm Description
Study Device
Outcomes
Primary Outcome Measures
Investigator Global Assessment
Investigator Global Assessment of Atopic Dermatitis Severity
Secondary Outcome Measures
Investigator Pruritus Assessment
Investigator Pruritus Severity Assessment
Subject Itch Assessment
Subject assessment of itch severity
Adverse Events
Number of subjects with related adverse events
Full Information
NCT ID
NCT01232985
First Posted
October 26, 2010
Last Updated
May 29, 2012
Sponsor
Oculus Innovative Sciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01232985
Brief Title
Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculus Innovative Sciences, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Pruritus
Keywords
Atopic Dermatitis, Pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RD047-26
Arm Type
Experimental
Arm Description
Study Device
Intervention Type
Device
Intervention Name(s)
RD047-26
Intervention Description
RD047-26 emollient gel
Primary Outcome Measure Information:
Title
Investigator Global Assessment
Description
Investigator Global Assessment of Atopic Dermatitis Severity
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Investigator Pruritus Assessment
Description
Investigator Pruritus Severity Assessment
Time Frame
2 weeks
Title
Subject Itch Assessment
Description
Subject assessment of itch severity
Time Frame
2 weeks
Title
Adverse Events
Description
Number of subjects with related adverse events
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoe Draelos, M.D.
Organizational Affiliation
Dermatology Consulting Services, High Point NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults
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