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

NCT00755196 | Completed Phase 2 Results

• 2 other identifiers: AN2728-PSR-202C3291015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque type psoriasis

Conditions

Psoriasis

Keywords

Plaque Type Psoriasis; Topical

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84

  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 indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.

  Day 84

Secondary Outcomes (1)

• Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91

  Day 7, 14, 28, 42, 56, 70, 91

Study Arms (2)

1

ACTIVE COMPARATOR

AN2728 Ointment, 5%

Drug: AN2728

2

PLACEBO COMPARATOR

AN2728 Ointment vehicle

Drug: Ointment vehicle

Interventions

AN2728 DRUG

AN2728 Ointment, 5%, twice daily for 12 weeks

Also known as: AN2728 Ointment, 5%

1

Ointment vehicle DRUG

Ointment vehicle, twice daily for 12 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \>18 years of age at time of enrollment
• The clinical diagnosis of stable plaque psoriasis
• Two target plaques of similar severity
• ≥ 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
• Bilaterally located (right/left) plaques on the arms or distinct plaques located on the trunk. Plaques located on the trunk must be separated by at least 10 cm and will be designated by the Investigator as either left/right or front/back or upper/lower
• 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 individual plaques
• Normal or not clinically significant screening laboratory results
• 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

You may not qualify if:

• 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
• 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 or surgically sterile (oophorectomy).
• Washout periods of:
• Topical drugs that might alter the course of psoriasis: 2 weeks
• Oral retinoids: 8 weeks
• Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks
• PUVA: 4 weeks
• UVB therapy: 4 weeks
• Use of emollients/moisturizers on area(s) to be treated: 2 days 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

IMIC

Mexico City, Mexico City, 06700, Mexico

Location

MeSH Terms

Conditions

Psoriasis

Interventions

crisaborole; Ointments

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer,Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Locations

ME (1)