Psoriasis Clinical Trial
Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris
Summary
This study examines the effect of Goeckerman therapy (a combination of phototherapy and topical crude coal tar), crude coal tar alone, and phototherapy alone on the immunologic and genetic environment within psoriatic skin lesions.
Full Description
This is a three-arm, open-label study to examine the effect of Goeckerman therapy. Goeckerman therapy is known for its high efficacy and favorable safety profile in the treatment of psoriasis. It consists of a combination of phototherapy and topical crude coal tar). This study will examine how Goeckerman therapy, crude coal tar alone, and phototherapy alone affect the mmunologic and genetic environment within psoriatic skin lesions. Fifteen subjects with moderate to severe psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to further elucidate the mechanism of action by which Goeckerman treatment improves psoriatic skin lesions.
Eligibility Criteria
Inclusion criteria
Male or female ≥ 18 years of age at enrollment.
Documentation of predominately moderate to severe plaque psoriasis for at least 6 months prior to enrollment.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Subject is considered a candidate for phototherapy or systemic therapy
Body Surface Area (BSA) ≥ 5%.
Physical exam within clinically acceptable limits.
Exclusion criteria
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Subject has predominantly non-plaque form of psoriasis.
Subject has drug-induced psoriasis.
Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
Patient has absolute or relative contraindication to phototherapy, including photosensitizing disorders.
Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
Known HIV positive status.
Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.
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