PsoriasisNCT03392337
An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients
A study testing Narrowband UVB phototherapy in people with Psoriasis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
Trial summary
A single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Narrowband UVB phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 adults ≥ 18 years of age.
- Diagnosis of chronic plaque-type psoriasis for at least 6 months
- Moderate to Severe plaque psoriasis as defined by BSA ≥10 PASI ≥12 IGA ≥3
- Able to give written informed consent prior to performance of any study related procedures
- Subject is able to attend Narrowband UVB phototherapy sessions three times a week and all other protocol specified visits
- Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.
Who cannot join
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
- History of photosensitivity
- Subject has used ustekinumab and/or anti-IL-17 biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
- Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
- Patient used topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
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- Initiated within 3 months, planned initiation of, or changes to, concomitant medications that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors ) during the trial
- Active infections requiring antibiotics in the 2 weeks prior to Baseline
- Patient received UVB phototherapy within 4 weeks of Baseline.
- Patient received PUVA phototherapy within 4 weeks of Baseline.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Elise Nelson
East Windsor, New Jersey, 08520
Jerry Bagel, 609-443-4500, dreamacres1@aol.com
Elise Nelson, 6094434500
About this study
A single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response.
Read the detailed description
30 subjects will be treated with increasing doses of Narrowband Ultraviolet phototherapy three times weekly for 12 weeks. Patients will then be evaluated every 6 weeks through week 36 to determine maintenance of response.
- Conditions
- Psoriasis
- Being tested
- Narrowband UVB phototherapy
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrowband UVB phototherapyDevice
Ultraviolet B phototherapy
| Study group | Role | What they receive |
|---|---|---|
| Open Label Narrowband UVB phototherapy | Experimental | Open Label Narrowband UVB phototherapy for 12 weeks. Receives: Device: Narrowband UVB phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis area severity index score
PASI 75
Measured: 12 weeks
Secondary outcomes (3)
Physicians Global Assessment
PGA improvement
Measured: 12 weeks
Body Surface Area
BSA improvement
Measured: 12 weeks
Physician's Global Assessments multiplied by Body surface area
PGA x BSA
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 posted5 Jan 2018
- Study start7 Nov 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psoriasis Treatment Center of Central New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392337
- Sponsor's protocol ID
- PTC02
- Status last verified
- Jan 2019
- First submitted
- 29 Dec 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients
- ClinicalTrials.gov ID
- NCT03392337
- Acronym / sponsor ID
- PTC02
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 5 Jan 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.
A single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response.
Detailed description
30 subjects will be treated with increasing doses of Narrowband Ultraviolet phototherapy three times weekly for 12 weeks. Patients will then be evaluated every 6 weeks through week 36 to determine maintenance of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| Open Label Narrowband UVB phototherapy | Experimental | Device: Narrowband UVB phototherapyOpen Label Narrowband UVB phototherapy for 12 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 adults ≥ 18 years of age.
- Diagnosis of chronic plaque-type psoriasis for at least 6 months
- Moderate to Severe plaque psoriasis as defined by BSA ≥10 PASI ≥12 IGA ≥3
- Able to give written informed consent prior to performance of any study related procedures
- Subject is able to attend Narrowband UVB phototherapy sessions three times a week and all other protocol specified visits
Key exclusion criteria (10 listed)
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
- History of photosensitivity
- Subject has used ustekinumab and/or anti-IL-17 biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
- Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
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 |
|---|---|---|
| Narrowband UVB phototherapyUltraviolet B phototherapy | Device | Open Label Narrowband UVB phototherapy |
Primary outcome
Psoriasis area severity index score
Time frame: 12 weeks
PASI 75
3 secondary outcomes
Physicians Global Assessment
Time frame: 12 weeks
Body Surface Area
Time frame: 12 weeks
Physician's Global Assessments multiplied by Body surface area
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrowband UVB phototherapy in people with Psoriasis, run by Psoriasis Treatment Center of Central New Jersey 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 10 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: looking for participants now, as of the sponsor's last update on 30 Jan 2019. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerry Bagel, MD (6094434500, dreamacres1@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis area severity index score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2019.