Photoprovocation Testing in Subjects With Cutaneous Lupus

July 12, 2021 updated by: University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Phototesting
Other: Phototesting
Single MED dose on Day 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours.
Time Frame: 24 hours and 48 hours
24 hours and 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

July 2, 2018

Study Completion (ACTUAL)

July 2, 2018

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (ESTIMATE)

January 25, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 814860

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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