AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-26

Study Completion Date

2011-06-06

Brief Summary

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The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AN2728 ointment, 2%

Group Type EXPERIMENTAL

AN2728 ointment, 2%

Intervention Type DRUG

AN2728 ointment, 2%, applied twice daily for 12 weeks

Ointment Vehicle

Group Type PLACEBO_COMPARATOR

Ointment Vehicle

Intervention Type DRUG

Ointment Vehicle, applied twice daily for 12 weeks

Interventions

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AN2728 ointment, 2%

AN2728 ointment, 2%, applied twice daily for 12 weeks

Intervention Type DRUG

Ointment Vehicle

Ointment Vehicle, applied twice daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of total body surface area (BSA) excluding face, scalp, and genitals
* Willingness and ability to apply study medication as directed, comply with study instructions, and commit to attending all study visits
* Women of childbearing potential must agree to use contraception for the entire study period

Exclusion Criteria

* Any dermatological conditions that could interfere with clinical evaluations
* Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
* Significant confounding conditions as assessed by study doctor
* Participated in any other trial of an investigational drug within 30 days or participation in a research study concurrent with this study
* 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
* Pregnancy or lactation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No