Photoprovocation Testing in Subjects With Cutaneous Lupus

NCT ID: NCT01516788

Last Updated: 2021-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2018-07-02

Brief Summary

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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.

Detailed Description

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Conditions

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Lupus Erythematosus Photosensitivity Conditions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Phototesting

Group Type EXPERIMENTAL

Phototesting

Intervention Type OTHER

Single MED dose on Day 2

Interventions

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Phototesting

Single MED dose on Day 2

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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814860

Identifier Type: -

Identifier Source: org_study_id

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