A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993420
• Other study ID #: DRM02-ADM02
• 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 atopic dermatitis when applied twice daily for 6 weeks.

Description:

This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with atopic dermatitis 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 the Physician's Lesion Assessment (PLA) and the Eczema Area and Severity Index (EASI) from only the two lesions identified at the baseline visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• 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 stable atopic dermatitis (AD) and with two lesions of similar size and have an identical score of at least 5 but no more than 9 on the sum of the individual components of the Eczema Area and Severity Index (EASI) at the Target Lesion scale.

• Male or non-pregnant, non-lactating females.

• Signed informed consent.

Exclusion Criteria:

• Subjects who have unstable atopic dermatitis (AD).

• Significant infection at the target lesion site.

• Prior or concomitant use of systemic therapies for AD within the past 4 weeks. - Prior or concomitant use of topical treatments for AD, to within 10 cm of the target lesion within the past 4 weeks.

• Prior or concomitant use of oral retinoids for AD within the last 6 months.

• Use of biologics for AD within the past 3 months, or 5 half-lives (whichever is longer).

• Subjects who have poor skin condition within 5 cm of the target lesion.

• Subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease; 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

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• DRM02

Other:
• Vehicle

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dermira, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physician's Lesion Assessment dichotomized into "success" and "failure"		Week 6
Other	Severity of Target Lesion EASI scores		Week 6
Primary	Change in Physician's Lesion Assessment		Week 6
Secondary	Physician's Lesion Assessment analyzed for treatment effect		From baseline to weeks 1, 2, 3, 4 and 6