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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

AN2728

Ointment vehicle

About this trial

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

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
The clinical diagnosis of stable plaque psoriasis
Two target plaques of similar severity
- ≥ 5 cm2 but ≤ 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 distinct plaques located on the trunk. Plaques located on the trunk must be separated by at least 10 cm and will be designated by the Investigator as either left/right or front/back or upper/lower
- 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 individual plaques
Normal or not clinically significant screening laboratory results
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 that could interfere with clinical evaluations or any disease state or physical condition which 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).
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 or surgically sterile (oophorectomy).
Washout periods of:
- Topical drugs that might alter the course of psoriasis: 2 weeks
- Oral retinoids: 8 weeks
- Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks
- PUVA: 4 weeks
- UVB therapy: 4 weeks
- Use of emollients/moisturizers on area(s) to be treated: 2 days to baseline visit
AIDS or AIDS related illness
Concurrent participation in another drug research study or within 30 days of enrollment
Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil)
Use of a beta-blocking medication (i.e. propranolol) if the dose has not been stabilized for at least 3 months

Sites / Locations

IMIC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

AN2728 Ointment, 5%

AN2728 Ointment vehicle

Outcomes

Primary Outcome Measures

Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84

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 indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.

Secondary Outcome Measures

Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91

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 indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 28, 42, 56, 70 and 91 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.

Full Information

NCT ID

NCT00755196

First Posted

September 17, 2008

Last Updated

January 12, 2017

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00755196

Brief Title

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

Official Title

A Double-Blind, Randomized, 12 Week, Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment 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

September 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (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, 5%, compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque type psoriasis

Detailed Description

This is a single center, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test articles, AN2728 Ointment, 5%, and Ointment 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

Plaque Type Psoriasis, Topical

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

AN2728 Ointment, 5%

Arm Title

Arm Type

Placebo Comparator

Arm Description

AN2728 Ointment vehicle

Intervention Type

Drug

Intervention Name(s)

AN2728

Other Intervention Name(s)

AN2728 Ointment, 5%

Intervention Description

AN2728 Ointment, 5%, twice daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Ointment vehicle

Intervention Description

Ointment vehicle, twice daily for 12 weeks

Primary Outcome Measure Information:

Title

Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84

Description

Time Frame

Day 84

Secondary Outcome Measure Information:

Title

Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91

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 score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 28, 42, 56, 70 and 91 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.

Time Frame

Day 7, 14, 28, 42, 56, 70, 91

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 The clinical diagnosis of stable plaque psoriasis Two target plaques of similar severity ≥ 5 cm2 but ≤ 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 distinct plaques located on the trunk. Plaques located on the trunk must be separated by at least 10 cm and will be designated by the Investigator as either left/right or front/back or upper/lower 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 individual plaques Normal or not clinically significant screening laboratory results 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 that could interfere with clinical evaluations or any disease state or physical condition which 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). 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 or surgically sterile (oophorectomy). Washout periods of: Topical drugs that might alter the course of psoriasis: 2 weeks Oral retinoids: 8 weeks Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks PUVA: 4 weeks UVB therapy: 4 weeks Use of emollients/moisturizers on area(s) to be treated: 2 days to baseline visit AIDS or AIDS related illness Concurrent participation in another drug research study or within 30 days of enrollment Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil) Use of a beta-blocking medication (i.e. propranolol) if the dose has not been stabilized for at least 3 months

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:

Facility Name

IMIC

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06700

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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