Clinical trial NCT00759161: Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Plaque Type Psoriasis
Topical
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: Inclusion Criteria:

1. Male or female \>18 years of age at time of enrollment.
2. The clinical diagnosis of stable plaque psoriasis.
3. 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).
4. Normal or not clinically significant screening laboratory results.
5. Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits.
6. 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:

1. 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
2. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below)
3. Known sensitivity to any of the components of the study medication
4. Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis
5. Concomitant use of topical or systemic therapies that might alter the course of psoriasis
6. Females of child bearing potential. Females must be post-menopausal (based on FSH levels) or surgically sterile (oophorectomy)
7. 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
8. AIDS or AIDS related illness
9. Concurrent participation in another drug research study or within 30 days of enrollment
10. Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil)
11. Use of a beta-blocking medication (i.e. propranolol) if the dose has not been stabilized for at least 3 months

Primary outcomes:
measure: Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
timeFrame: Baseline (Day 1), Day 7,14, 21, 28, 35
measure: Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
timeFrame: Baseline (Day 1), Day 7,14, 21, 28, 35
measure: Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
timeFrame: Baseline (Day 1), Day 7,14, 21, 28, 35
measure: Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
timeFrame: Baseline (Day 1), Day 7,14, 21, 28, 35
measure: Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35
timeFrame: Day 7,14, 21, 35
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: IMIC
state: Distrito Federal
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: