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Completed

NCT Number: NCT01232985

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RD047-26

Device

RD047-26 emollient gel

Primary outcomes

  1. Investigator Global Assessment

    Time frame: 2 weeks

    Investigator Global Assessment of Atopic Dermatitis Severity

Secondary outcomes

  1. Investigator Pruritus Assessment

    Time frame: 2 weeks

    Investigator Pruritus Severity Assessment

  2. Subject Itch Assessment

    Time frame: 2 weeks

    Subject assessment of itch severity

  3. Adverse Events

    Time frame: 2 weeks

    Number of subjects with related adverse events

Sponsors and collaborators

Lead sponsor

Oculus Innovative Sciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 2, 2010
Registry last updated
May 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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