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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
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus Photosensitivity Conditions Other: Phototesting Not Applicable

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Phototesting Other: Phototesting
Single MED dose on Day 2


Outcome Measures
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Primary Outcome Measures :
  1. The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours. [ Time Frame: 24 hours and 48 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  1. Participants who do not meet criteria for either CLE or SLE.
  2. Participants with a diagnosis of Erythropoietic Protoporphyria and Solar Urticaria, or another photodermatoses other than Polymorphous light eruption.
  3. Participants who are not yet 18 years old or who are not capable of giving written informed consent prior to enrolling in the study.
  4. Participants who have undergone any recent phototesting, or phototherapy exposure, or those who are suspected of having a drug-induced photosensitivity.
  5. Female participants who are pregnant or breastfeeding will be excluded from the study. This will be determined by patient self-reporting.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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         
Sponsors and Collaborators
University of Pennsylvania
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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