A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

NCT01993420 | Completed Phase 2

• 1 other identifier: DRM02-ADM02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change in Physician's Lesion Assessment

  Week 6

Secondary Outcomes (1)

• Physician's Lesion Assessment analyzed for treatment effect

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

Other Outcomes (2)

• Physician's Lesion Assessment dichotomized into "success" and "failure"

  Week 6

• Severity of Target Lesion EASI scores

  Week 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dermira, Inc.: lead

Study Sites (2)

Clinique Médicale Dr Isabelle Delorme

Drummondville, Quebec, J2B5L4, Canada

Location

Innovaderm Research, Inc

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System 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 (2)