Photoprovocation Testing in Subjects With Cutaneous Lupus
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ClinicalTrials.gov Identifier: NCT01516788 |
Recruitment Status
:
Recruiting
First Posted
: January 25, 2012
Last Update Posted
: September 12, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lupus Erythematosus Photosensitivity Conditions | Other: Phototesting | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Photoprovocation Testing in Subjects With Cutaneous Lupus |
Study Start Date : | December 2011 |
Estimated Primary Completion Date : | July 2018 |
Estimated Study Completion Date : | July 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Phototesting |
Other: Phototesting
Single MED dose on Day 2
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- The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours. [ Time Frame: 24 hours and 48 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516788
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Victoria Werth, MD 215-898-0168 werth@mail.med.upenn.edu | |
Principal Investigator: Victoria Werth, MD |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01516788 History of Changes |
Other Study ID Numbers: |
814860 |
First Posted: | January 25, 2012 Key Record Dates |
Last Update Posted: | September 12, 2016 |
Last Verified: | September 2016 |