A Safety and Efficacy Study of DRM02 in Subjects With Rosacea

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

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

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Other: Vehicle; Drug: DRM02

Detailed Description

This is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with rosacea 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 inflammatory lesion counts, the Investigator's Global Evaluation (IGE) and the Rosacea Signs and Symptoms (RSS) scale.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Windsor, Ontario, Canada, N8W 5W7
      • Windsor Clinical Research, Inc.
  • Quebec
    • Drummondville, Quebec, Canada, J2B5L4
      • Clinique Médicale Dr Isabelle Delorme
    • Montreal, Quebec, Canada, H2K 4L5
      • Innovaderm Research, Inc

Participation Criteria

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 rosacea with a score of 2 or 3 on the Investigator's Global Evaluation (IGE) of Rosacea scale and at least 15 and not more than 40 papules.
• Subjects willing to minimize external factors that might trigger rosacea flare-ups.
• Male or non-pregnant, non-lactating females.
• Signed informed consent.

Exclusion Criteria:

• Severe self-reported facial sensitivity.
• Severe sun sensitivity.
• Ocular-only, phymatous rosacea or steroid rosacea.
• Use of topical rosacea treatments in the 4 weeks prior to baseline.
• Use of systemic corticosteroids within the 4 weeks prior to baseline.
• Use of systemic antibiotics in the 4 weeks prior to baseline.
• Use of systemic retinoids for in the 6 months prior to baseline.
• Use of topical retinoids in the 3 months prior to baseline.
• Use of light- or laser-based rosacea treatments in the past 2 months prior to baseline.
• Cosmetic procedures within the 2 months prior to baseline.
• Use of topical anti-aging medications in the 2 weeks prior to baseline.
• Subjects who have poor skin condition within 5 cm of the treatment area.
• Subjects who are current drug or alcohol abusers; have a history of immunodeficiency 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

How is the study designed?

Design Details

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

Number of Arms

2

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 inflammatory lesion count	Week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Investigator's Global Evaluation (IGE)	From baseline to weeks 0, 1, 2, 3, 4 and 6
IGE dichotomized into "success" and "failure"	Week 6
Percent change in inflammatory lesions	Week 6

Other Outcome Measures

Outcome Measure	Time Frame
Rosacea Signs and Symptoms (RSS)	From baseline to weeks 0, 1, 2, 3, 4 and 6

Collaborators and Investigators

• Sponsor: Dermira, Inc.

Study record dates

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: Skin Diseases; Rosacea
• Other Study ID Numbers: DRM02-ROS02