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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
IMIC
Mexico City, Distrito Federal, 06700 Mexico
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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

NCT00759161
Pfizer
Completed
Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected].com

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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