Psoriasis VulgarisPhase 1NCT03662685
Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris
A Phase 1 study testing Goeckerman Therapy, Crude Coal Tar Only and Phototherapy Only in people with Psoriasis Vulgaris and Psoriasis, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris, Psoriasis
- What is being tested?
- Goeckerman Therapy, Crude Coal Tar Only and Phototherapy Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, 94118
About this study
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.
Read the 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.
- Conditions
- Psoriasis Vulgaris, Psoriasis
- Being tested
- Goeckerman Therapy, Crude Coal Tar Only, Phototherapy Only
- Keywords
- goeckerman, phototherapy, psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goeckerman TherapyOther
Also called Combination Treatment with Phototherapy and Crude Coal Tar, Goeckerman Regimen
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.
Crude Coal Tar OnlyDrug
Also called Coal tar
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.
Phototherapy OnlyDevice
Also called Ultraviolet B, Narrowband ultraviolet B, NB-UVB, UVB phototherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Goeckerman Therapy | Active comparator | Patients with psoriasis who will receive Goeckerman therapy 5 days per week for 6 weeks. Receives: 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. Receives: 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. Receives: Drug: Crude Coal Tar Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Aug 2018
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: Closing of the Goeckerman program at UCSF and loss of funding, PI left UCSF
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Psoriasis Foundation
- Responsible party
- Sponsor
- Investigators
- Tina Bhutani, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662685
- Sponsor's protocol ID
- Goeckerman Immunogenetics
- Status last verified
- Jul 2025
- First submitted
- 5 Oct 2017
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23892536Menter 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.
PubMed 6886105Moscaliuc 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.
PubMed 22329632van 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.
PubMed 23348739Li 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.
PubMed 24441097Gupta 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.
PubMed 27015450Sekhon 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.
PubMed 28814117Zhu 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.
PubMed 27474032
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenetic Profiling of Goeckerman Therapy in the Treatment of Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT03662685
- Acronym / sponsor ID
- Goeckerman Immunogenetics
- Conditions
- Psoriasis Vulgaris, Psoriasis
- Keywords
- goeckerman, phototherapy, psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closing of the Goeckerman program at UCSF and loss of funding, PI left UCSF
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Psoriasis Foundation
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Goeckerman Therapy | Active comparator | Other: Goeckerman TherapyPatients with psoriasis who will receive Goeckerman therapy 5 days per week for 6 weeks. |
| Phototherapy Only | Active comparator | Device: Phototherapy OnlyPatients with psoriasis who will receive narrowband ultraviolet B (NB-UVB) phototherapy 3 days per week for 12 weeks. |
| Crude Coal Tar Only | Active comparator | Drug: Crude Coal Tar OnlyPatients with psoriasis who will receive skin treatment with crude coal tar only 5 days per week for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goeckerman TherapyAlso: Combination Treatment with Phototherapy and Crude Coal Tar, Goeckerman RegimenThe 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 | Goeckerman Therapy |
| Crude Coal Tar OnlyAlso: Coal tarA 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. | Drug | Crude Coal Tar Only |
| Phototherapy OnlyAlso: Ultraviolet B, Narrowband ultraviolet B, NB-UVB, UVB phototherapyLight 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. | Device | Phototherapy Only |
Primary outcome
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.
1 secondary outcome
Number of differentially expressed genes and pathways
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Closing of the Goeckerman program at UCSF and loss of funding, PI left UCSF). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 23892536Gupta 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.
- Background: PubMed 6886105Menter 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.
- Background: PubMed 22329632Moscaliuc 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.
- Background: PubMed 23348739van 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.
- Background: PubMed 24441097Li 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.
- Background: PubMed 27015450Gupta 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.
- Background: PubMed 28814117Sekhon 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.
- Background: PubMed 27474032Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Bhutani, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Goeckerman Therapy, Crude Coal Tar Only and Phototherapy Only in people with Psoriasis Vulgaris and Psoriasis, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Closing of the Goeckerman program at UCSF and loss of funding, PI left UCSF). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of differentially expressed immune cell populations (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03662685, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.