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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01993446
Other study ID # DRM02-ROS02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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