Photoprovocation Testing in Subjects With Cutaneous Lupus | NCT01516788

Studies
Photoprovocation Testing in Subjects With Cutaneous Lupus

NCT01516788

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Jul 13, 2021Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Lupus Erythematosus
Photosensitivity Conditions

Interventions

Phototesting

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jul 2, 2018Actual

Completion Date

Jul 2, 2018Actual

First Submitted Date

Jan 12, 2012

First Submission Date that Met QC Criteria

Jan 19, 2012

First Posted Date

Jan 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2021

Last Update Posted Date

Jul 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phototesting	Experimental		Other: Phototesting

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phototesting	Other	Single MED dose on Day 2	Phototesting

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States