Clinical trial NCT03662685: Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris
Official title: Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Psoriasis
Keywords: goeckerman
phototherapy
psoriasis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Psoriasis Foundation
First posted: 2018-09-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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

1. Male or female ≥ 18 years of age at enrollment.
2. Documentation of predominately moderate to severe plaque psoriasis for at least 6 months prior to enrollment.
3. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
4. Subject is considered a candidate for phototherapy or systemic therapy
5. Body Surface Area (BSA) ≥ 5%.
6. Physical exam within clinically acceptable limits.

Exclusion criteria

1. 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.
2. Subject has predominantly non-plaque form of psoriasis.
3. Subject has drug-induced psoriasis.
4. Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
5. Patient has absolute or relative contraindication to phototherapy, including photosensitizing disorders.
6. Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
7. Known HIV positive status.
8. Known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents.

Primary outcomes:
measure: Number of differentially expressed immune cell populations
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of differentially expressed genes and pathways
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Psoriasis and Skin Treatment Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Tina Bhutani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gupta R, Debbaneh M, Butler D, Huynh M, Levin E, Leon A, Koo J, Liao W. The Goeckerman regimen for the treatment of moderate to severe psoriasis. J Vis Exp. 2013 Jul 11;(77):e50509. doi: 10.3791/50509.
citation: Menter A, Cram DL. The Goeckerman regimen in two psoriasis day care centers. J Am Acad Dermatol. 1983 Jul;9(1):59-65. doi: 10.1016/s0190-9622(83)70107-6.
citation: Moscaliuc ML, Heller MM, Lee ES, Koo J. Goeckerman therapy: a very effective, yet often forgotten treatment for severe generalized psoriasis. J Dermatolog Treat. 2013 Feb;24(1):34-7. doi: 10.3109/09546634.2012.658014. Epub 2012 Mar 4.
citation: van den Bogaard EH, Bergboer JG, Vonk-Bergers M, van Vlijmen-Willems IM, Hato SV, van der Valk PG, Schroder JM, Joosten I, Zeeuwen PL, Schalkwijk J. Coal tar induces AHR-dependent skin barrier repair in atopic dermatitis. J Clin Invest. 2013 Feb;123(2):917-27. doi: 10.1172/JCI65642. Epub 2013 Jan 25.
citation: Li B, Tsoi LC, Swindell WR, Gudjonsson JE, Tejasvi T, Johnston A, Ding J, Stuart PE, Xing X, Kochkodan JJ, Voorhees JJ, Kang HM, Nair RP, Abecasis GR, Elder JT. Transcriptome analysis of psoriasis in a large case-control sample: RNA-seq provides insights into disease mechanisms. J Invest Dermatol. 2014 Jul;134(7):1828-1838. doi: 10.1038/jid.2014.28. Epub 2014 Jan 17.
citation: Gupta R, Ahn R, Lai K, Mullins E, Debbaneh M, Dimon M, Arron S, Liao W. Landscape of Long Noncoding RNAs in Psoriatic and Healthy Skin. J Invest Dermatol. 2016 Mar;136(3):603-609. doi: 10.1016/j.jid.2015.12.009. Epub 2015 Dec 18.
citation: Sekhon S, Jeon C, Nakamura M, Afifi L, Yan D, Wu JJ, Liao W, Bhutani T. Review of the mechanism of action of coal tar in psoriasis. J Dermatolog Treat. 2018 May;29(3):230-232. doi: 10.1080/09546634.2017.1369494. Epub 2017 Sep 19.
citation: Zhu TH, Nakamura M, Farahnik B, Abrouk M, Singh RK, Lee KM, Hulse S, Koo J, Bhutani T, Liao W. The Patient's Guide to Psoriasis Treatment. Part 4: Goeckerman Therapy. Dermatol Ther (Heidelb). 2016 Sep;6(3):333-9. doi: 10.1007/s13555-016-0132-7. Epub 2016 Jul 29.