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

Last updated on March 14, 2019

Study Location
Mexico City, D.f., Mexico
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Females and Males
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

- 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

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


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


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[email protected]

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