Lupus ErythematosusNCT01516788
Photoprovocation Testing in Subjects With Cutaneous Lupus
A study testing Phototesting in people with Lupus Erythematosus and Photosensitivity Conditions, run by University of Pennsylvania at 1 site in United States.
Trial summary
Photosensitivity is well documented among lupus patients and is one of the diagnostic criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in lupus and has a wide range of clinical presentations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Photosensitivity Conditions
- What is being tested?
- Phototesting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to 2 Jul 2018
- 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
- Participants who have a diagnosis of CLE based on either the Gilliam classification of DLE and SCLE, or SLE based on the American College of Rheumatology criteria.
Who cannot join
- Participants who do not meet criteria for either CLE or SLE.
- Participants with a diagnosis of Erythropoietic Protoporphyria and Solar Urticaria, or another photodermatoses other than Polymorphous light eruption.
- Participants who are not yet 18 years old or who are not capable of giving written informed consent prior to enrolling in the study.
- Participants who have undergone any recent phototesting, or phototherapy exposure, or those who are suspected of having a drug-induced photosensitivity.
- Female participants who are pregnant or breastfeeding will be excluded from the study. This will be determined by patient self-reporting.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Photosensitivity is well documented among lupus patients and is one of the diagnostic criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in lupus and has a wide range of clinical presentations. However, photosensitivity is a poorly defined in lupus and its pathogenesis is not well understood. The purpose of this study is to characterize the early clinical and histopathological changes in lupus skin that occur as a response to ultraviolet light.
- Conditions
- Lupus Erythematosus, Photosensitivity Conditions
- Being tested
- Phototesting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototestingOther
Single MED dose on Day 2
| Study group | Role | What they receive |
|---|---|---|
| Phototesting | Experimental | Not described Receives: Other: Phototesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours.
Measured: 24 hours and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startDec 2011
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516788
- Sponsor's protocol ID
- 814860
- Status last verified
- Jul 2021
- First submitted
- 12 Jan 2012
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoprovocation Testing in Subjects With Cutaneous Lupus
- ClinicalTrials.gov ID
- NCT01516788
- Acronym / sponsor ID
- 814860
- Conditions
- Lupus Erythematosus, Photosensitivity Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 25 Jan 2012 (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.
Photosensitivity is well documented among lupus patients and is one of the diagnostic criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in lupus and has a wide range of clinical presentations. However, photosensitivity is a poorly defined in lupus and its pathogenesis is not well understood. The purpose of this study is to characterize the early clinical and histopathological changes in lupus skin that occur as a response to ultraviolet light.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phototesting | Experimental | Other: Phototesting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who have a diagnosis of CLE based on either the Gilliam classification of DLE and SCLE, or SLE based on the American College of Rheumatology criteria.
Key exclusion criteria (5 listed)
- Participants who do not meet criteria for either CLE or SLE.
- Participants with a diagnosis of Erythropoietic Protoporphyria and Solar Urticaria, or another photodermatoses other than Polymorphous light eruption.
- Participants who are not yet 18 years old or who are not capable of giving written informed consent prior to enrolling in the study.
- Participants who have undergone any recent phototesting, or phototherapy exposure, or those who are suspected of having a drug-induced photosensitivity.
- Female participants who are pregnant or breastfeeding will be excluded from the study. This will be determined by patient self-reporting.
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 |
|---|---|---|
| PhototestingSingle MED dose on Day 2 | Other | Phototesting |
Primary outcome
The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours.
Time frame: 24 hours and 48 hours
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 13 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototesting in people with Lupus Erythematosus and Photosensitivity Conditions, run by University of Pennsylvania 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 1 inclusion and 5 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 13 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 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?
The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours. (time frame: 24 hours and 48 hours). 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 13 Jul 2021.