NCT01232985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

2 months

First QC Date

October 26, 2010

Last Update Submit

May 29, 2012

Conditions

Atopic DermatitisPruritus

Keywords

Atopic DermatitisPruritus

Outcome Measures

Primary Outcomes (1)

  • Investigator Global Assessment

    Investigator Global Assessment of Atopic Dermatitis Severity

    2 weeks

Secondary Outcomes (3)

  • Investigator Pruritus Assessment

    2 weeks

  • Subject Itch Assessment

    2 weeks

  • Adverse Events

    2 weeks

Study Arms (1)

RD047-26

EXPERIMENTAL

Study Device

Device: RD047-26

Interventions

RD047-26DEVICE

RD047-26 emollient gel

RD047-26

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Conditions

Dermatitis, AtopicPruritus

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zoe Draelos, M.D.

    Dermatology Consulting Services, High Point NC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2010

First Posted

November 2, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

US(1)