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A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

DRM02

Vehicle

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinique Médicale Dr Isabelle Delorme
Innovaderm Research, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DRM02

Vehicle

Arm Description

DRM02 Topical Gel, 0.25%

DRM02 Topical Gel, Vehicle

Outcomes

Primary Outcome Measures

Change in Physician's Lesion Assessment

Secondary Outcome Measures

Physician's Lesion Assessment analyzed for treatment effect

Full Information

NCT ID

NCT01993420

First Posted

November 15, 2013

Last Updated

July 16, 2021

Sponsor

Dermira, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01993420

Brief Title

A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dermira, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DRM02

Arm Type

Experimental

Arm Description

DRM02 Topical Gel, 0.25%

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

DRM02 Topical Gel, Vehicle

Intervention Type

Drug

Intervention Name(s)

DRM02

Intervention Type

Other

Intervention Name(s)

Vehicle

Primary Outcome Measure Information:

Title

Change in Physician's Lesion Assessment

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

Physician's Lesion Assessment analyzed for treatment effect

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Time Frame

Week 6

Title

Severity of Target Lesion EASI scores

Time Frame

Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beth Zib

Organizational Affiliation

Dermira, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Clinique Médicale Dr Isabelle Delorme

City

Drummondville

State/Province

Quebec

ZIP/Postal Code

J2B5L4

Country

Canada

Facility Name

Innovaderm Research, Inc

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2K 4L5

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

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