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Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

Primary Purpose

Psoriasis Vulgaris, Psoriasis

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Goeckerman Therapy

Crude Coal Tar Only

Phototherapy Only

About this trial

This is an interventional basic science trial for Psoriasis Vulgaris focused on measuring goeckerman, phototherapy, psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UCSF Psoriasis and Skin Treatment CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Goeckerman Therapy

Phototherapy Only

Crude Coal Tar Only

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of differentially expressed genes and pathways

Quantify the number of differentially expressed genes in each cell population by RNA-sequencing at weeks 0, 2, 4, 12 after receiving traditional Goeckerman therapy (NB-UVB + coal tar), coal tar only, and NB-UVB therapy only.

Full Information

NCT ID

NCT03662685

First Posted

October 5, 2017

Last Updated

April 3, 2023

Sponsor

University of California, San Francisco

Collaborators

National Psoriasis Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03662685

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

National Psoriasis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis Vulgaris, Psoriasis

Keywords

goeckerman, phototherapy, psoriasis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Goeckerman Therapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Phototherapy Only

Arm Type

Active Comparator

Arm Description

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

Arm Title

Crude Coal Tar Only

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Goeckerman Therapy

Other Intervention Name(s)

Combination Treatment with Phototherapy and Crude Coal Tar, Goeckerman Regimen

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Crude Coal Tar Only

Other Intervention Name(s)

Coal tar

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Phototherapy Only

Other Intervention Name(s)

Ultraviolet B, Narrowband ultraviolet B, NB-UVB, UVB phototherapy, Phototherapy, Light treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of differentially expressed immune cell populations

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Number of differentially expressed genes and pathways

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Quinn Thibodeaux, MD

Phone

415-944-7618

psoriasis@ucsf.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kristen Beck, MD

Phone

415-944-7618

psoriasis@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tina Bhutani, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF Psoriasis and Skin Treatment Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94118

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Quinn Thibodeaux, MD

Phone

415-944-7618

psoriasis@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Kristen Beck, MD

Phone

415-944-7618

psoriasis@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23892536

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.

Results Reference

background

PubMed Identifier

6886105

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.

Results Reference

background

PubMed Identifier

22329632

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.

Results Reference

background

PubMed Identifier

23348739

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.

Results Reference

background

PubMed Identifier

24441097

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.

Results Reference

background

PubMed Identifier

27015450

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.

Results Reference

background

PubMed Identifier

28814117

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. Erratum In: J Dermatolog Treat. 2018 May;29(3):x.

Results Reference

background

PubMed Identifier

27474032

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.

Results Reference

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Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

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