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Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Double-Blind, Randomized Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment Vehicle in the Treatment of Patients With Plaque Type Psoriasis

NCT00759161•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis.

Detailed Description

This is a multi-center, randomized, double-blind bilateral design. Patients will apply the test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female \>18 years of age at time of enrollment.
•2. The clinical diagnosis of stable plaque psoriasis.
•3. Two target plaques of similar severity
•1. ≥ 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.
•2. Bilaterally located (right/left) plaques on the arms or plaques located on the upper and lower trunk. Plaques located on the trunk were to be separated by at least 10 cm and designated by the Investigator as either left/right or front/back.
•3. Target plaque severity score of 2-4 (mild to moderate).
•4. Normal or not clinically significant screening laboratory results.
•5. Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits.
•6. Subjects who had the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol related procedures.

Exclusion Criteria

•1. 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
•2. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below)
•3. Known sensitivity to any of the components of the study medication
•4. Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis
•5. Concomitant use of topical or systemic therapies that might alter the course of psoriasis
•6. Females of child bearing potential. Females must be post-menopausal (based on FSH levels) or surgically sterile (oophorectomy)
•7. Washout periods of:
•1. Topical drugs that might alter the course of psoriasis: 2 weeks
•2. Oral retinoids: 8 weeks
•3. Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks
+7 more criteria

Locations (1)

IMIC

Mexico City, Mexico City, Mexico

Key Dates

Start Date

November 1, 2007

Primary Completion Date

March 1, 2008

Completion Date

March 1, 2008

Last Updated

March 6, 2017

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

AN2728

DRUG

AN2728 Ointment Vehicle

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments