Efficacy and Tolerability Study of Device, RD047-26 for t... | NCT01232985

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

NCT01232985

Sponsor

Oculus Innovative Sciences, Inc.

Status

Completed

Last Update Posted

May 30, 2012Estimated

Enrollment

17Actual

Phase

Phase 2

Conditions

Atopic Dermatitis
Pruritus

Interventions

RD047-26

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Oct 26, 2010

First Submission Date that Met QC Criteria

Nov 1, 2010

First Posted Date

Nov 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2012

Last Update Posted Date

May 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RD047-26	Experimental	Study Device	Device: RD047-26

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RD047-26	Device	RD047-26 emollient gel	RD047-26

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigator Global Assessment	Investigator Global Assessment of Atopic Dermatitis Severity	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Investigator Pruritus Assessment	Investigator Pruritus Severity Assessment	2 weeks
Subject Itch Assessment	Subject assessment of itch severity

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zoe Draelos, M.D.	Dermatology Consulting Services, High Point NC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology Consulting Services		High Point	North Carolina	27262	United States

Type	Date	Date Unknown
Release	Apr 10, 2018
Reset	May 11, 2018
Release	May 14, 2018
Reset	Jun 12, 2018

Submission Tracking

Estimated Results First Submitted Date

Apr 10, 2018

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 10, 2018			May 11, 2018
May 14, 2018

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic
D011537	Pruritus

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided