Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis - Full Text View

Purpose

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

Condition	Intervention	Phase
Psoriasis	Drug: AN2728 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Crisaborole

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle [ Time Frame: Day 42 ]
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 [ Time Frame: Day 42 ]
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.


Enrollment:	145
Study Start Date:	November 2009
Study Completion Date:	June 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1. AN2728 Ointment B 2%, administered twice daily	Drug: AN2728 Ointment B, 2% or 0.5% applied once or twice daily
Placebo Comparator: 2. AN2728 Ointment B Vehicle	Drug: Placebo Ointment B Vehicle applied once or twice daily
Active Comparator: 3. AN2728 Ointment B 2%, administered once daily	Drug: AN2728 Ointment B, 2% or 0.5% applied once or twice daily
Active Comparator: 4. AN2728 Ointment B 0.5%, administered twice daily	Drug: AN2728 Ointment B, 2% or 0.5% applied once or twice daily
Active Comparator: 5. AN2728 Ointment B 0.5%, administered once daily	Drug: AN2728 Ointment B, 2% or 0.5% applied once or twice daily

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029405

Locations


Mexico

Mexico City, D.f., Mexico

Zapopan, Jalisco, Mexico

Monterrey, Nuevo Leon, Mexico

Monterrey, Nuevo León, Mexico

Chihuahua, Mexico

San Luis Potosí, Mexico

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01029405 History of Changes
Other Study ID Numbers:	AN2728-PSR-203 C3291016 ( Other Identifier: Pfizer )
Study First Received:	December 7, 2009
Results First Received:	January 12, 2017
Last Updated:	January 12, 2017

Keywords provided by Pfizer:


Topical Plaque type psoriasis

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases

ClinicalTrials.gov processed this record on July 17, 2017

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