Photoprovocation Testing in Subjects With Cutaneous Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01516788
Recruitment Status : Recruiting
First Posted : January 25, 2012
Last Update Posted : September 12, 2016
Information provided by (Responsible Party):
University of Pennsylvania

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 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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:

  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.

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 identifier (NCT number): NCT01516788

United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Victoria Werth, MD    215-898-0168   
Principal Investigator: Victoria Werth, MD         
Sponsors and Collaborators
University of Pennsylvania

Responsible Party: University of Pennsylvania 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