A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

Sponsor
Dermira, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01993420
Collaborator
(none)
21
2
2
5
10.5
2.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Atopic Dermatitis
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: DRM02

DRM02 Topical Gel, 0.25%

Drug: DRM02

Placebo Comparator: Vehicle

DRM02 Topical Gel, Vehicle

Other: Vehicle

Outcome Measures

Primary Outcome Measures

  1. Change in Physician's Lesion Assessment [Week 6]

Secondary Outcome Measures

  1. Physician's Lesion Assessment analyzed for treatment effect [From baseline to weeks 1, 2, 3, 4 and 6]

Other Outcome Measures

  1. Physician's Lesion Assessment dichotomized into "success" and "failure" [Week 6]

  2. Severity of Target Lesion EASI scores [Week 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique Médicale Dr Isabelle Delorme Drummondville Quebec Canada J2B5L4
2 Innovaderm Research, Inc Montreal Quebec Canada H2K 4L5

Sponsors and Collaborators

  • Dermira, Inc.

Investigators

  • Study Director: Beth Zib, Dermira, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dermira, Inc.
ClinicalTrials.gov Identifier:
NCT01993420
Other Study ID Numbers:
  • DRM02-ADM02
First Posted:
Nov 25, 2013
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021