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Photoprovocation Testing in Subjects With Cutaneous Lupus

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01516788
First received: January 12, 2012
Last updated: September 8, 2016
Last verified: September 2016
History of Changes
  Purpose
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 Intervention
Lupus Erythematosus
Photosensitivity Conditions
 Other: Phototesting

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Photoprovocation Testing in Subjects With Cutaneous Lupus

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours. [ Time Frame: 24 hours and 48 hours ] [ Designated as safety issue: No ]
Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phototesting Other: Phototesting
Single MED dose on Day 2

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01516788     History of Changes
Other Study ID Numbers: 814860 
Study First Received: January 12, 2012
Last Updated: September 8, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 29, 2016