Photoprovocation Testing in Subjects With Cutaneous Lupus

This study is currently recruiting participants.

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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 ]


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)
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:

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.

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

ClinicalTrials.gov processed this record on June 28, 2017

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