A Safety and Efficacy Study of DRM02 in Subjects With Rosacea

NCT ID: NCT01993446

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-03-31

Brief Summary

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.

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.

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

DRM02

DRM02 Topical Gel, 0.25%

Group Type: EXPERIMENTAL

DRM02

Intervention Type: DRUG

Vehicle

DRM02 Topical Gel, Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: OTHER

Interventions

DRM02

Intervention Type: DRUG

Vehicle

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dermira, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beth Zib

Role: STUDY_DIRECTOR

Dermira, Inc.

Locations

Windsor Clinical Research, Inc.

Windsor, Ontario, Canada

Clinique Médicale Dr Isabelle Delorme

Drummondville, Quebec, Canada

Innovaderm Research, Inc

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

DRM02-ROS02

Identifier Type: -

Identifier Source: org_study_id