Phase 2 N=68 Randomized Quadruple-blind Treatment

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

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT01300052 ↗

Enrolled (actual)

Serious AEs

2.9%

Results posted

Mar 2017

Primary outcome: Primary: Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84 — 17.4; 13.6 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AN2728 ointment, 2% (Drug); Ointment Vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84	17.4; 13.6	—
SECONDARY Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70	2.2; 0; 8.7; 4.5; 26.1; 18.2	—
SECONDARY Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84	-2.1; -1.4	—
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	23; 12; 0; 2	—
SECONDARY Number of Treatment-Emergent Adverse Events (TEAEs) by Severity	14; 11; 25; 5; 5; 5	—
SECONDARY Number of Participants With Local Tolerability Symptoms: Burning/Stinging	31; 18; 5; 1; 4; 0	—
SECONDARY Number of Participants With Local Tolerability Symptoms: Pruritus	23; 13; 8; 6; 5; 0	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01300052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.