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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
Mexico City, D.f., 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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- Male or female >18 years of age at time of enrollment

- Clinical diagnosis of stable plaque type psoriasis

- Two target plaques of similar severity meeting the following criteria:

- 5 cm2 and ≤ 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 trunk. Plaques
located on the trunk must be separated by at least 10 cm 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 two target plaques

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Any dermatological conditions, disease state or physical condition that could
interfere with clinical evaluations or might expose the patient to an unacceptable
risk by study participation

- Any underlying disease(s) or other dermatological conditions that require the use of
exclusionary topical or systemic therapy (see below)

- Clinically significant, abnormal Screening laboratory results (unless approved by the
medical monitor)

- 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 (hysterectomy or bilateral oophorectomy)

- Washout periods for exclusionary therapies:

Oral retinoids: 8 weeks Non-retinoid systemic drugs that might alter the course of
psoriasis: 4 weeks Psoralens with UV-A (PUVA): 4 weeks Ultraviolet-B (UVB) therapy: 4 weeks
Topical drugs that might alter the course of psoriasis: 2 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 or device research study or within 30 days
prior to enrollment

- 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

- Use of AN2728 in a previous clinical trial

NCT01029405
Pfizer
Completed
Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

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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