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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01232985

Enrollment

Registered

2010-11-02

Start date

2010-10-31

Completion date

2010-12-31

Last updated

2012-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Pruritus

Keywords

Atopic Dermatitis, Pruritus

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.

Interventions

DEVICERD047-26

RD047-26 emollient gel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Investigator Pruritus Assessment	2 weeks	Investigator Pruritus Severity Assessment
Subject Itch Assessment	2 weeks	Subject assessment of itch severity
Adverse Events	2 weeks	Number of subjects with related adverse events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026