A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

July 16, 2021 updated by: Dermira, Inc.

A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Atopic Dermatitis

The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of atopic dermatitis when applied twice daily for 6 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with atopic dermatitis and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.

Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs.

Preliminary efficacy will be assessed through the Physician's Lesion Assessment (PLA) and the Eczema Area and Severity Index (EASI) from only the two lesions identified at the baseline visit.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Drummondville, Quebec, Canada, J2B5L4
        • Clinique Médicale Dr Isabelle Delorme
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female 18 to 70 years of age.
  • Clinical diagnosis of stable atopic dermatitis (AD) and with two lesions of similar size and have an identical score of at least 5 but no more than 9 on the sum of the individual components of the Eczema Area and Severity Index (EASI) at the Target Lesion scale.
  • Male or non-pregnant, non-lactating females.
  • Signed informed consent.

Exclusion Criteria:

  • Subjects who have unstable atopic dermatitis (AD).
  • Significant infection at the target lesion site.
  • Prior or concomitant use of systemic therapies for AD within the past 4 weeks. - Prior or concomitant use of topical treatments for AD, to within 10 cm of the target lesion within the past 4 weeks.
  • Prior or concomitant use of oral retinoids for AD within the last 6 months.
  • Use of biologics for AD within the past 3 months, or 5 half-lives (whichever is longer).
  • Subjects who have poor skin condition within 5 cm of the target lesion.
  • Subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease; or are a poor medical risk because of other systemic diseases or active uncontrolled infections.
  • Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.
  • Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days.
  • Subjects who have a clinically significant laboratory value at screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DRM02
DRM02 Topical Gel, 0.25%
Drug: DRM02
Placebo Comparator: Vehicle
DRM02 Topical Gel, Vehicle
Other: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Physician's Lesion Assessment
Time Frame: Week 6
Week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Physician's Lesion Assessment analyzed for treatment effect
Time Frame: From baseline to weeks 1, 2, 3, 4 and 6
From baseline to weeks 1, 2, 3, 4 and 6

Other Outcome Measures

Outcome Measure
Time Frame
Physician's Lesion Assessment dichotomized into "success" and "failure"
Time Frame: Week 6
Week 6
Severity of Target Lesion EASI scores
Time Frame: Week 6
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dermira, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRM02-ADM02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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