Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

NCT03662685 | Terminated Phase 1 FDA Drug FDA Device

• 1 other identifier: Goeckerman Immunogenetics
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris; Psoriasis

Keywords

goeckerman; phototherapy; psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of differentially expressed immune cell populations

  Perform quantitative analysis of the immunologic and genetic changes in immune cell populations after treatment with traditional Goeckerman (NBUVB + coal tar), coal tar only, and NB-UVB only, at weeks 2, 4, and 12 compared to baseline week 0. The immunologic profiles will be compared between subjects receiving the traditional Goeckerman therapy (NB-UVB + coal tar), coal tar only, and NB-UVB therapy only.

  12 weeks

Secondary Outcomes (1)

• Number of differentially expressed genes and pathways

  12 weeks

Study Arms (3)

Goeckerman Therapy

ACTIVE COMPARATOR

Patients with psoriasis who will receive Goeckerman therapy 5 days per week for 6 weeks.

Other: Goeckerman Therapy

Phototherapy Only

ACTIVE COMPARATOR

Patients with psoriasis who will receive narrowband ultraviolet B (NB-UVB) phototherapy 3 days per week for 12 weeks.

Device: Phototherapy Only

Crude Coal Tar Only

ACTIVE COMPARATOR

Patients with psoriasis who will receive skin treatment with crude coal tar only 5 days per week for 6 weeks.

Drug: Crude Coal Tar Only

Interventions

Goeckerman Therapy OTHER

The Goeckerman regimen consists of exposure to narrowband ultraviolet B (NB-UVB) light phototherapy and application of crude coal tar to the skin 5 days per week. The treatment will occur the UCSF outpatient skin treatment center for approximately 4-5 hours, 5 days a week for 6 weeks (total of 30 sessions). The treatment is consistent with the standard of care Goeckerman treatment protocol at UCSF.

Also known as: Combination Treatment with Phototherapy and Crude Coal Tar, Goeckerman Regimen

Goeckerman Therapy

Crude Coal Tar Only DRUG

A topical medication consisting of crude coal tar will be applied to the psoriatic skin under plastic wrap occlusion for approximately up to 4-5 hours, 5 days a week for 6 weeks (total of 30 sessions), at the outpatient skin treatment center at UCSF.

Also known as: Coal tar

Crude Coal Tar Only

Phototherapy Only DEVICE

Light treatment with narrowband ultraviolet B (NB-UVB) phototherapy three days per week for 12 weeks at the UCSF Phototherapy Center per the standard UCSF phototherapy protocol, in which starting dose is based on the subject's Fitzpatrick skin type and gradually increased as tolerated. Each phototherapy treatment will last approximately from under 1 minute to less than 15 minutes.

Also known as: Ultraviolet B, Narrowband ultraviolet B, NB-UVB, UVB phototherapy, Phototherapy, Light treatment

Phototherapy Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Psoriasis Foundation: collaborator

Study Sites (1)

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, 94118, United States

Location

Related Publications (8)

• 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.

  PMID: 23892536 BACKGROUND

• 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.

  PMID: 6886105 BACKGROUND

• 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.

  PMID: 22329632 BACKGROUND

• 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.

  PMID: 23348739 BACKGROUND

• 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.

  PMID: 24441097 BACKGROUND

• 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.

  PMID: 27015450 BACKGROUND

• 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.

  PMID: 28814117 BACKGROUND

• 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.

  PMID: 27474032 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Phototherapy; Coal Tar

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Tars; Complex Mixtures

Study Officials

• Tina Bhutani, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: September 7, 2018
• Study Start: August 1, 2018
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)