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Efficacy 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
Oculus Innovative Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Pruritus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 26, 2010
Last Updated
May 29, 2012
Sponsor
Oculus Innovative Sciences, Inc.
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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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