Psoriasis Clinical Trial
A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis
Summary
The aim of the proposed study is to evaluate the efficacy and safety of Enstilar Foam (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis.
Full Description
Eligible subjects will be provided twice daily. Enstilar Foam (calcipotriene and betamethasone dipropionate). Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The patient will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.
Eligibility Criteria
Inclusion Criteria:
Must have a diagnosis of nail psoriasis in fingernail or toenails
History of plaque psoriasis or psoriatic arthritis
Target nail will be KOH negative for dermatophyte fungus
Must give written informed consent prior to study procedures being conducted, also give consent to the release and use of protected health information (PHI)
Between the ages of 18 and 85 years old
Candidate for topical therapy in the opinion of the investigator
Exclusion Criteria:
Males and Females unable to practice effective contraception throughout the study
Unable to comply with the protocol
Nursing mothers, pregnant women, and women planning to become pregnant while in this study
Patients with erythrodermic or pustular psoriasis
Sustained treatment to target fingernail within 6 months prior to screening
History of trauma or surgery to target fingernail
History of disease known to affect nails such as lichen planus, onychomycosis
History of systemic psoriasis therapy for less than 6 months
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There is 1 Location for this study
Birmingham Alabama, 35233, United States
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