Psoriasis VulgarisPhase 1NCT00220025
Narrowband UVB Light Therapy to Patients With Dark Skin Types Who Have 10% of Their Body Involved With Psoriasis Vulgaris.
A Phase 1 study testing Phototherapy in people with Psoriasis Vulgaris, run by Mary Sullivan-Whalen at 1 site in United States.
Trial summary
This study offers narrowband UVB light therapy to patients with both light and dark skin types who have 10% of their body involved with psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to May 2009
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have stable psoriasis vulgaris, which covers at least 10% of their bodies, for at least six months. Patients can not have not been treated with narrowband UVB in the past, although other light therapies are acceptable (i.e. broadband UVB and PUVA). Patients are not allowed to receive other therapies for their psoriasis, internal and topical, while they are participating in the study. Patients may continue using non-medicated moisturizer.
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller University Hospital
New York, New York, 10021
About this study
Official title: A Study To Determine the Efficacy of Whole Body Narrowband UVB Phototherapy in People With Darker Skin Types
This study offers narrowband UVB light therapy to patients with both light and dark skin types who have 10% of their body involved with psoriasis vulgaris.
Read the detailed description
Two groups of patients, having 10% of their body surface area involved with psoriasis vulgaris, will receive narrowband phototherapy. One group will have skin type I-IV, or light skin and the second group will have dark skin, or type V-VI.
All patients will receive phototherapy, with narrowband UVB, three times a week for six weeks, or a total of 18 treatments. 6mm punch skin biopsies will be done prior to starting therapy and at the completion of the study. Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) of both groups will be compared.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Phototherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyDevice
The patient begins total body NBUVB that day at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until clearance of disease or maximum efficacy.
| Study group | Role | What they receive |
|---|---|---|
| NBUVB | Experimental | Not described Receives: Device: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and histological improvement of psoriasis
Measured: beginning and end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 1999
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Sullivan-Whalen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary Sullivan-Whalen, Rockefeller University
- Investigators
- James G. Krueger, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220025
- Sponsor's protocol ID
- JKR-0338
- Status last verified
- Oct 2012
- First submitted
- 20 Sep 2005
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnson-Huang LM, Suarez-Farinas M, Sullivan-Whalen M, Gilleaudeau P, Krueger JG, Lowes MA. Effective narrow-band UVB radiation therapy suppresses the IL-23/IL-17 axis in normalized psoriasis plaques. J Invest Dermatol. 2010 Nov;130(11):2654-63. doi: 10.1038/jid.2010.166. Epub 2010 Jun 17.
PubMed 20555351
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Determine the Efficacy of Whole Body Narrowband UVB Phototherapy in People With Darker Skin Types
- ClinicalTrials.gov ID
- NCT00220025
- Acronym / sponsor ID
- JKR-0338
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mary Sullivan-WhalenUniversity, hospital or other
- Study start
- Jun 1999
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- 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 offers narrowband UVB light therapy to patients with both light and dark skin types who have 10% of their body involved with psoriasis vulgaris.
Detailed description
Two groups of patients, having 10% of their body surface area involved with psoriasis vulgaris, will receive narrowband phototherapy. One group will have skin type I-IV, or light skin and the second group will have dark skin, or type V-VI.
All patients will receive phototherapy, with narrowband UVB, three times a week for six weeks, or a total of 18 treatments. 6mm punch skin biopsies will be done prior to starting therapy and at the completion of the study. Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) of both groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBUVB | Experimental | Device: Phototherapy |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have stable psoriasis vulgaris, which covers at least 10% of their bodies, for at least six months. Patients can not have not been treated with narrowband UVB in the past, although other light therapies are acceptable (i.e. broadband UVB and PUVA). Patients are not allowed to receive other therapies for their psoriasis, internal and topical, while they are participating in the study. Patients may continue using non-medicated moisturizer.
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| PhototherapyThe patient begins total body NBUVB that day at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until clearance of disease or maximum efficacy. | Device | NBUVB |
Primary outcome
Clinical and histological improvement of psoriasis
Time frame: beginning and end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Derived from this study: PubMed 20555351Johnson-Huang LM, Suarez-Farinas M, Sullivan-Whalen M, Gilleaudeau P, Krueger JG, Lowes MA. Effective narrow-band UVB radiation therapy suppresses the IL-23/IL-17 axis in normalized psoriasis plaques. J Invest Dermatol. 2010 Nov;130(11):2654-63. doi: 10.1038/jid.2010.166. Epub 2010 Jun 17.
Related trials for Psoriasis Vulgaris
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris
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.
James G. Krueger, MD principal investigator
Rockefeller University
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 Phototherapy in people with Psoriasis Vulgaris, run by Mary Sullivan-Whalen 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 25 Oct 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical and histological improvement of psoriasis (time frame: beginning and end of treatment). 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 NCT00220025, which also lists 1 linked publication.
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 25 Oct 2012.