A Safety and Efficacy Study of DRM02 in Subjects With Rosacea

NCT01993446 | Completed Phase 2

• 1 other identifier: DRM02-ROS02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Change in inflammatory lesion count

  Week 6

Secondary Outcomes (3)

• 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 Outcomes (1)

• Rosacea Signs and Symptoms (RSS)

  From baseline to weeks 0, 1, 2, 3, 4 and 6

Study Arms (2)

DRM02

EXPERIMENTAL

DRM02 Topical Gel, 0.25%

Drug: DRM02

Vehicle

PLACEBO COMPARATOR

DRM02 Topical Gel, Vehicle

Other: Vehicle

Interventions

DRM02 DRUG

DRM02

Vehicle OTHER

Vehicle

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dermira, Inc.: lead

Study Sites (3)

Windsor Clinical Research, Inc.

Windsor, Ontario, N8W 5W7, Canada

Location

Clinique Médicale Dr Isabelle Delorme

Drummondville, Quebec, J2B5L4, Canada

Location

Innovaderm Research, Inc

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Beth Zib

  Dermira, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

CA (3)