A Safety and Efficacy Study of DRM02 in Subjects With Plaque Psoriasis

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

The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of plaque psoriasis when applied twice daily for 6 weeks.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Vehicle; Drug: DRM02

Detailed Description

This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with plaque psoriasis 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 Severity of Psoriasis Area Severity Index (PASI) from only the two plaques identified at the baseline visit.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Drummondville, Quebec, Canada, J2B5L4
      • Clinique Médicale Dr Isabelle Delorme
    • Montreal, Quebec, Canada, H2K 4L5
      • Innovaderm Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female 18 to 70 years of age.
• Plaque-type psoriasis with two lesions of similar size and have an identical score of at least 6 but no more than 8 on the sum of the individual components of the Severity of Psoriasis Area Severity Index (PASI) at the Target Lesion scale.
• Male or non-pregnant, non-lactating females.
• Signed informed consent.

Exclusion Criteria:

• Subjects who have extensive, and/or 'inverse', and/or exfoliative psoriasis.
• Subjects who have taken any systemic treatment for psoriasis within the 4 weeks prior to baseline.
• Prior or concomitant use of topical treatments for psoriasis to within 10 cm of the target lesion within the 4 weeks prior to baseline.
• Use of Enbrel within the 4 weeks prior to baseline.
• Psoralen & ultraviolet A therapy (PUVA) or the use of ultraviolet B (UVB) therapy and/or excessive or prolonged exposure to ultraviolet light within the 4 weeks prior to baseline.
• Use of Humira or Remicade within the 3 months prior to baseline.
• Use of Stelara within the 6 months prior to baseline.
• Subjects who have taken oral retinoids for psoriasis within the 6 months prior to baseline.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DRM02; DRM02 Topical Gel, 0.25%	Drug: DRM02
PLACEBO_COMPARATOR: Vehicle; DRM02 Topical Gel, Vehicle	Other: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Physician's Lesion Assessment	Week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Physician's Lesion Assessment	From baseline to weeks 0, 1, 2, 3, 4 and 6
PLA dichotomized into "success" and "failure"	Week 6

Other Outcome Measures

Outcome Measure	Time Frame
Severity of Target Lesion PASI scores	Week 6

Collaborators and Investigators

• Sponsor: Dermira, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (ESTIMATE): November 25, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: DRM02-PSO02