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

Oculus Innovative Sciences

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis; Pruritus

Treatments: Device: RD047-26

Study type: Interventional

Funder types: Industry

Identifiers

NCT01232985

MIC-AD-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

RD047-26

Experimental group

Description:

Study Device

Treatment:

Device: RD047-26