PsoriasisNCT02165657
Excimer Laser, Serum Markers & Psoriasis
A study testing Excimer laser treatment in people with Psoriasis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The overall aims for this study are to determine whether UVB excimer laser treatment of psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer laser treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Excimer laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2017
- Phase
- Interventional
- 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
- Age 18 years and older
- Male or female with diagnosis of psoriasis
- Psoriasis involvement of 5-15% BSA
- Has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) for at least 4 weeks
- Has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks
- Fitzpatrick Skin Types I-VI
Who cannot join
- Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)
- Any suspicion that the psoriasis is of the photosensitive variant.
- Any medical condition that could be aggravated or may cause extreme discomfort during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center (Concord Site)
Concord, Ohio, 44077
About this study
Official title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients With Psoriasis
The overall aims for this study are to determine whether UVB excimer laser treatment of psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer laser treatment.
The investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm excimer laser will decrease the levels of serum inflammatory markers. The investigators hypothesize that treatment will decrease plaque erythema and will result in minimal hyperpigmentation.
Read the detailed description
Subjects will undergo Excimer treatment twice a week until they reach a PASI 75 improvement, or until they reach the maximum of 20 total treatments. A blood draw to assess serum inflammatory markers will be performed at the screening visit and final visit. Chromameter assessment, photographs, PASI and PGA (Physician Global Assessment) will be performed throughout the study to monitor psoriasis improvement, hyperpigmentation and erythema.
- Conditions
- Psoriasis
- Being tested
- Excimer laser treatment
- Keywords
- Excimer laser, UVB, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excimer laser treatmentDevice
Excimer laser irradiation twice a week for up to 20 treatments.
| Study group | Role | What they receive |
|---|---|---|
| Excimer laser | Experimental | Excimer laser treatment Receives: Device: Excimer laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum inflammatory markers
Change in CRP, MPO, S100 and Resistin levels from screening to final visit.
Measured: 23 visits (~12 weeks)
Secondary outcomes (4)
Objective measure of hyperpigmentation
Chromameter Assessment to measure hyperpigmentation. L* values are measured with a chromameter. A lower L* means more hyperpigmentation.
Measured: 23 visits (~12 weeks)
Objective measure of erythema
Chromameter Assessment to measure erythema. a* values are measured with a chromameter. A higher a* means more erythema.
Measured: 23 visits (~12 weeks)
Improvement in Psoriasis based on PASI assessment
PASI will be performed throughout the study to assess response to treatment.
Measured: 23 visits (~12 weeks)
Improvement in psoriasis based on PGA
PGA (Physician Global Assessment) will be performed throughout the study to assess response to treatment.
Measured: 23 visits (~12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Unable to recruit participants into trial
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.
- More trials run by University Hospitals Cleveland Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Photomedex
- Responsible party
- Principal investigator, Margaret Bobonich, NP, University Hospitals Cleveland Medical Center
- Investigators
- Margaret Bobonich, NP, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165657
- Sponsor's protocol ID
- 06-13-33
- Other IDs
- 06-13-33
- Status last verified
- Jul 2021
- First submitted
- 13 Jun 2014
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT02165657
- Acronym / sponsor ID
- 06-13-33
- Conditions
- Psoriasis
- Keywords
- Excimer laser, UVB, Psoriasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants into trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Photomedex
- Study start
- Sep 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Jun 2014 (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.
The overall aims for this study are to determine whether UVB excimer laser treatment of psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer laser treatment.
The investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm excimer laser will decrease the levels of serum inflammatory markers. The investigators hypothesize that treatment will decrease plaque erythema and will result in minimal hyperpigmentation.
Detailed description
Subjects will undergo Excimer treatment twice a week until they reach a PASI 75 improvement, or until they reach the maximum of 20 total treatments. A blood draw to assess serum inflammatory markers will be performed at the screening visit and final visit. Chromameter assessment, photographs, PASI and PGA (Physician Global Assessment) will be performed throughout the study to monitor psoriasis improvement, hyperpigmentation and erythema.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Excimer laser | Experimental | Device: Excimer laser treatmentExcimer laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and older
- Male or female with diagnosis of psoriasis
- Psoriasis involvement of 5-15% BSA
- Has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) for at least 4 weeks
- Has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks
Key exclusion criteria (3 listed)
- Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)
- Any suspicion that the psoriasis is of the photosensitive variant.
- Any medical condition that could be aggravated or may cause extreme discomfort during the study period.
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 |
|---|---|---|
| Excimer laser treatmentExcimer laser irradiation twice a week for up to 20 treatments. | Device | Excimer laser |
Primary outcome
Change in serum inflammatory markers
Time frame: 23 visits (~12 weeks)
Change in CRP, MPO, S100 and Resistin levels from screening to final visit.
4 secondary outcomes
Objective measure of hyperpigmentation
Time frame: 23 visits (~12 weeks)
Objective measure of erythema
Time frame: 23 visits (~12 weeks)
Improvement in Psoriasis based on PASI assessment
Time frame: 23 visits (~12 weeks)
Improvement in psoriasis based on PGA
Time frame: 23 visits (~12 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
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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.
Margaret Bobonich, NP principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excimer laser treatment in people with Psoriasis, run by University Hospitals Cleveland Medical Center 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 3 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: withdrawn, as of the sponsor's last update on 16 Jul 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in serum inflammatory markers (time frame: 23 visits (~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 16 Jul 2021.