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Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT03662685
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
National Psoriasis Foundation
Information provided by (Responsible Party):
Tina Bhutani, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Psoriasis Other: Goeckerman Therapy Drug: Crude Coal Tar Only Device: Phototherapy Only Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : November 7, 2019
Estimated Study Completion Date : November 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Coal Tar

Arm Intervention/treatment
Active Comparator: Goeckerman Therapy
Patients with psoriasis who will receive Goeckerman therapy 5 days per week for 6 weeks.
Other: Goeckerman Therapy
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.
Other Names:
  • Combination Treatment with Phototherapy and Crude Coal Tar
  • Goeckerman Regimen

Active Comparator: Phototherapy Only
Patients with psoriasis who will receive narrowband ultraviolet B (NB-UVB) phototherapy 3 days per week for 12 weeks.
Device: Phototherapy Only
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.
Other Names:
  • Ultraviolet B
  • Narrowband ultraviolet B
  • NB-UVB
  • UVB phototherapy
  • Phototherapy
  • Light treatment

Active Comparator: Crude Coal Tar Only
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
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.
Other Name: Coal tar




Primary Outcome Measures :
  1. Number of differentially expressed immune cell populations [ Time Frame: 12 weeks ]
    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 :
  1. Number of differentially expressed genes and pathways [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662685


Contacts
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Contact: Quinn Thibodeaux, MD 415-944-7618 psoriasis@ucsf.edu
Contact: Kristen Beck, MD 415-944-7618 psoriasis@ucsf.edu

Locations
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United States, California
UCSF Psoriasis and Skin Treatment Center Recruiting
San Francisco, California, United States, 94118
Contact: Quinn Thibodeaux, MD    415-944-7618    psoriasis@ucsf.edu   
Contact: Kristen Beck, MD    415-944-7618    psoriasis@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Psoriasis Foundation
Investigators
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Principal Investigator: Tina Bhutani, MD University of California, San Francisco

Publications:

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Responsible Party: Tina Bhutani, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03662685     History of Changes
Other Study ID Numbers: Goeckerman Immunogenetics
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tina Bhutani, University of California, San Francisco:
goeckerman
phototherapy
psoriasis

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Coal Tar
Keratolytic Agents
Dermatologic Agents