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OpenTrials
Completed

NCT Number: NCT01516788

Photoprovocation Testing in Subjects With Cutaneous Lupus

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.

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Key information

Conditions

Lupus Erythematosus Photosensitivity Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phototesting

Other

Single MED dose on Day 2

Primary outcomes

  1. The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours.

    Time frame: 24 hours and 48 hours

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2012
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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