Photoprovocation Testing in Subjects With Cutaneous Lupus
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Pennsylvania.
Recruitment status was Recruiting
Information provided by (Responsible Party):
VICTORIA WERTH, University of Pennsylvania
First received: January 12, 2012
Last updated: July 20, 2012
Last verified: July 2012
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.
||Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
||Photoprovocation Testing in Subjects With Cutaneous Lupus
Primary Outcome Measures:
- The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2012 (Final data collection date for primary outcome measure)
Single MED dose on Day 2
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01516788
|University of Pennsylvania
|Philadelphia, Pennsylvania, United States, 19104 |
|Contact: Victoria Werth, MD 215-898-0168 firstname.lastname@example.org |
|Principal Investigator: Victoria Werth, MD |
University of Pennsylvania
No publications provided
ClinicalTrials.gov processed this record on September 18, 2014
||VICTORIA WERTH, Principal Investigator, University of Pennsylvania
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 12, 2012
||July 20, 2012
||United States: Institutional Review Board