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Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis (AN2728PSR203)

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

AN2728

Placebo

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Topical, Plaque type psoriasis

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

1. AN2728 Ointment B

2. AN2728 Ointment B Vehicle

3. AN2728 Ointment B

4. AN2728 Ointment B

5. AN2728 Ointment B

Arm Description

2%, administered twice daily

2%, administered once daily

0.5%, administered twice daily

0.5%, administered once daily

Outcomes

Primary Outcome Measures

Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle

OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.

Secondary Outcome Measures

Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle

OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported.

Full Information

NCT ID

NCT01029405

First Posted

December 7, 2009

Last Updated

January 12, 2017

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01029405

Brief Title

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

Acronym

AN2728PSR203

Official Title

A Double-Blind,Randomized, 12 Week, Bilateral Study of the Safety and Efficacy of AN2728 Ointment B, 2% and 0.5%, Versus Ointment B Vehicle in the Treatment of Patients With Plaque Type Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Psoriasis

Keywords

Topical, Plaque type psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

145 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1. AN2728 Ointment B

Arm Type

Active Comparator

Arm Description

2%, administered twice daily

Arm Title

2. AN2728 Ointment B Vehicle

Arm Type

Placebo Comparator

Arm Title

3. AN2728 Ointment B

Arm Type

Active Comparator

Arm Description

2%, administered once daily

Arm Title

4. AN2728 Ointment B

Arm Type

Active Comparator

Arm Description

0.5%, administered twice daily

Arm Title

5. AN2728 Ointment B

Arm Type

Active Comparator

Arm Description

0.5%, administered once daily

Intervention Type

Drug

Intervention Name(s)

AN2728

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Ointment B Vehicle applied once or twice daily

Primary Outcome Measure Information:

Title

Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle

Description

Time Frame

Day 42

Secondary Outcome Measure Information:

Title

Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle

Description

OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported.

Time Frame

Day 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

City

Mexico City

State/Province

D.f.

Country

Mexico

City

Zapopan

State/Province

Jalisco

Country

Mexico

City

Monterrey

State/Province

Nuevo Leon

Country

Mexico

City

Monterrey

State/Province

Nuevo León

Country

Mexico

City

Chihuahua

Country

Mexico

City

San Luis Potosí

Country

Mexico

12. IPD Sharing Statement

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

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