Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis

NCT ID: NCT01029405

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment B, 2.0% and 0.5%, compared to Ointment Vehicle B, applied once or twice daily for 12 weeks, in the treatment of plaque type psoriasis

Detailed Description

This is a multicenter, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test article AN2728 Ointment B (0.5% or 2%), and Ointment B Vehicle twice daily for 12 weeks. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1. AN2728 Ointment B

2%, administered twice daily

Group Type: ACTIVE_COMPARATOR

AN2728

Intervention Type: DRUG

Ointment B, 2% or 0.5% applied once or twice daily

2. AN2728 Ointment B Vehicle

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Ointment B Vehicle applied once or twice daily

3. AN2728 Ointment B

2%, administered once daily

Group Type: ACTIVE_COMPARATOR

AN2728

Intervention Type: DRUG

Ointment B, 2% or 0.5% applied once or twice daily

4. AN2728 Ointment B

0.5%, administered twice daily

Group Type: ACTIVE_COMPARATOR

AN2728

Intervention Type: DRUG

Ointment B, 2% or 0.5% applied once or twice daily

5. AN2728 Ointment B

0.5%, administered once daily

Group Type: ACTIVE_COMPARATOR

AN2728

Intervention Type: DRUG

Ointment B, 2% or 0.5% applied once or twice daily

Interventions

AN2728

Ointment B, 2% or 0.5% applied once or twice daily

Intervention Type: DRUG

Placebo

Ointment B Vehicle applied once or twice daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female >18 years of age at time of enrollment
• Clinical diagnosis of stable plaque type psoriasis
• Two target plaques of similar severity meeting the following criteria:

• 5 cm2 and ≤ 100 cm2, computed by multiplying the greatest diameter of the plaque by the diameter of the plaque perpendicular to the greatest diameter Bilaterally located (right/left) plaques on the arms or plaques located on the trunk. Plaques located on the trunk must be separated by at least 10 cm Overall target plaque severity score (OTPSS) of 2-4 (mild to moderate) with no more than a 1 point difference in the scores of the two target plaques
• Willing and able to apply study drug as directed, comply with study instructions and commit to all follow-up visits
• Ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol related procedures

Exclusion Criteria

• Any dermatological conditions, disease state or physical condition that could interfere with clinical evaluations or might expose the patient to an unacceptable risk by study participation
• Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below)
• Clinically significant, abnormal Screening laboratory results (unless approved by the medical monitor)
• Known sensitivity to any of the components of the study medication
• Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis
• Concomitant use of topical or systemic therapies that might alter the course of psoriasis
• Females of child bearing potential. Females must be post-menopausal (based on FSH levels) or surgically sterile (hysterectomy or bilateral oophorectomy)
• Washout periods for exclusionary therapies:

Oral retinoids: 8 weeks Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks Psoralens with UV-A (PUVA): 4 weeks Ultraviolet-B (UVB) therapy: 4 weeks Topical drugs that might alter the course of psoriasis: 2 weeks Use of emollients/moisturizers on area(s) to be treated: 2 days prior to Baseline visit

• AIDS or AIDS-related illness
• Concurrent participation in another drug or device research study or within 30 days prior to enrollment
• Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil)
• Use of a beta-blocking medication (e.g., Propranolol) if the dose has not been stabilized for at least 3 months
• Use of AN2728 in a previous clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Chihuahua City, Chihuahua, Mexico

Mexico City, D.f., Mexico

Zapopan, Jalisco, Mexico

Monterrey, Nuevo León, Mexico

San Luis Potosí City, San Luis Potosí, Mexico

Countries

Mexico

Other Identifiers

C3291016

Identifier Type: OTHER

Identifier Source: secondary_id

AN2728-PSR-203

Identifier Type: -

Identifier Source: org_study_id