Photoprovocation Testing in Subjects With Cutaneous Lupus

Lupus Erythematosus Clinical Trial

Official title:

Photoprovocation Testing in Subjects With Cutaneous Lupus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516788
• Other study ID #: 814860
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: July 2, 2018

Study information

• Verified date: July 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus
• Photosensitivity Conditions

Intervention

Other:
• Phototesting
Single MED dose on Day 2

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours.		24 hours and 48 hours