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Photoprovocation Testing in Subjects With Cutaneous Lupus

This study is currently recruiting participants.
Verified July 2012 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
VICTORIA WERTH, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01516788
First received: January 12, 2012
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Lupus Erythematosus
Photosensitivity Conditions
 Other: Phototesting

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Photoprovocation Testing in Subjects With Cutaneous Lupus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phototesting Other: Phototesting
Single MED dose on Day 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516788

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Victoria Werth, MD     215-898-0168     werth@mail.med.upenn.edu    
Principal Investigator: Victoria Werth, MD            
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: VICTORIA WERTH, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01516788     History of Changes
Other Study ID Numbers: 814860
Study First Received: January 12, 2012
Last Updated: July 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dermatitis, Contact
Dermatitis, Phototoxic
Epilepsy, Reflex
Lupus Erythematosus, Systemic
Dermatitis, Irritant
Dermatitis
Skin Diseases
Photosensitivity Disorders
 Skin Diseases, Eczematous
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013