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

NCT01993433 | Completed Phase 2

• 1 other identifier: DRM02-PSO02
• Study Type: interventional
• Target: 23
• 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 plaque psoriasis when applied twice daily for 6 weeks.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change in Physician's Lesion Assessment

  Week 6

Secondary Outcomes (2)

• Physician's Lesion Assessment

  From baseline to weeks 0, 1, 2, 3, 4 and 6

• PLA dichotomized into "success" and "failure"

  Week 6

Other Outcomes (1)

• Severity of Target Lesion PASI 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.
• 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.

You may not qualify if:

• 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.

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

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue 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)