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

NCT00759161 | Completed Phase 2 Results

• 2 other identifiers: AN2728-PSR-201C3291014
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Keywords

Plaque Type Psoriasis; Topical

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28

  OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating 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 28 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 28

Secondary Outcomes (5)

• Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35

  Baseline (Day 1), Day 7,14, 21, 28, 35

• Change From Baseline in Erythema at Day 7,14, 21, 28 and 35

  Baseline (Day 1), Day 7,14, 21, 28, 35

• Change From Baseline in Scaling at Day 7,14, 21, 28 and 35

  Baseline (Day 1), Day 7,14, 21, 28, 35

• Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35

  Baseline (Day 1), Day 7,14, 21, 28, 35

• Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35

  Day 7,14, 21, 35

Study Arms (2)

1

ACTIVE COMPARATOR

AN2728 Ointment, 5%

Drug: AN2728

2

PLACEBO COMPARATOR

AN2728 Ointment Vehicle

Drug: AN2728 Ointment Vehicle

Interventions

AN2728 DRUG

AN2728 Ointment, 5%, twice daily for 4 weeks

Also known as: AN2728 Ointment, 5%

1

AN2728 Ointment Vehicle DRUG

AN2728 Ointment Vehicle, twice daily for 4 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 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.
• 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.

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 (based on FSH levels) 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 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

IMIC

Mexico City, Mexico City, 06700, Mexico

Location

MeSH Terms

Conditions

Psoriasis

Interventions

crisaborole

Condition Hierarchy (Ancestors)

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

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 23, 2008
• First Posted: September 25, 2008
• Study Start: November 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Locations

ME (1)