NCT01516788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2018

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

6.6 years

First QC Date

January 12, 2012

Last Update Submit

July 12, 2021

Conditions

Lupus ErythematosusPhotosensitivity Conditions

Outcome Measures

Primary Outcomes (1)

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

    24 hours and 48 hours

Study Arms (1)

Phototesting

EXPERIMENTAL
Other: Phototesting

Interventions

PhototestingOTHER

Single MED dose on Day 2

Phototesting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 25, 2012

Study Start

December 1, 2011

Primary Completion

July 2, 2018

Study Completion

July 2, 2018

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations

US(1)