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

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: AN2728 Drug: AN2728 Ointment Vehicle	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:

Overall Target Plaque Severity Assessment (OTPSS) at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change of Overall Target Plaque Severity Score and erythema, scaling and plaque elevation assessments from baseline [ Time Frame: Days 7, 14, 21, 28 and 35 ] [ Designated as safety issue: No ]
Overall Target Plaque Severity Assessment (OTPSS) at Days 7, 14, 21 and 35 [ Time Frame: Days 7, 14, 21 and 35 ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	November 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 AN2728 Ointment, 5%	Drug: AN2728 AN2728 Ointment, 5%, twice daily for 4 weeks Other Name: AN2728 Ointment, 5%
Placebo Comparator: 2 AN2728 Ointment Vehicle	Drug: AN2728 Ointment Vehicle AN2728 Ointment Vehicle, twice daily for 4 weeks. Other Name: AN2728 Ointment Vehicle

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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).
Normal or not clinically significant screening laboratory results.
Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits.
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:

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 (based on FSH levels) or surgically sterile (oophorectomy)
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
4. PUVA: 4 weeks
5. UVB therapy: 4 weeks
6. 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759161

Locations

Mexico
IMIC
Mexico City, Distrito Federal, Mexico, 06700

Sponsors and Collaborators

Anacor Pharmaceuticals, Inc.

Investigators

Study Director:

Karl Beutner, MD, PhD

Anacor Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Karl Beutner, MD, PhD, Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00759161 History of Changes
Other Study ID Numbers:	AN2728-PSR-201
Study First Received:	September 23, 2008
Last Updated:	February 9, 2011
Health Authority:	United States: Food and Drug Administration Mexico: Ministry of Health

Keywords provided by Anacor Pharmaceuticals, Inc.:

Plaque Type Psoriasis
Topical

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013