A Safety and Efficacy Study of DRM02 in Subjects With Rosacea

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993446
• Other study ID #: DRM02-ROS02
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• DRM02

Other:
• Vehicle

Locations

Country	Name	City	State
Canada	Clinique Médicale Dr Isabelle Delorme	Drummondville	Quebec
Canada	Innovaderm Research, Inc	Montreal	Quebec
Canada	Windsor Clinical Research, Inc.	Windsor	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dermira, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rosacea Signs and Symptoms (RSS)		From baseline to weeks 0, 1, 2, 3, 4 and 6
Primary	Change in inflammatory lesion count		Week 6
Secondary	Investigator's Global Evaluation (IGE)		From baseline to weeks 0, 1, 2, 3, 4 and 6
Secondary	IGE dichotomized into "success" and "failure"		Week 6
Secondary	Percent change in inflammatory lesions		Week 6