Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)

March 8, 2016 updated by: Spirig Pharma Ltd.

Investigation of the Efficacy of Different Sunscreens in Patients With Photosensitive Cutaneous Lupus Erythematosus

Part I: to investigate the efficacy of different sunscreens in the prevention of skin lesions following standardized photoprovocation with Ultraviolet A/Ultraviolet B (UVA/UVB) light in patients with CLE.

Part II: to evaluate the influence of different sunscreens on the expression of biomarkers in the skin of patients with CLE and of Healthy Controls following UV irradiation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Part I

Part I-interventions will be:

  • Experimental intervention: Application of broad-spectrum sunscreens with a low, medium, and high Sun Protection Factor (SPF) in random order to uninvolved skin areas prior to standardized photoprovocation.
  • Control intervention: Intra-individual application of vehicle in random order; standardized photoprovocation of vehicle treated and untreated areas.

Part II

Part II-interventions will be:

  • Experimental intervention: Application of a broad-spectrum sunscreen with a high SPF to uninvolved skin areas prior to UV irradiation.
  • Control intervention: UV irradiation of untreated areas.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Münster, Germany, 48149
        • Klinik und Poliklinik für Hautkrankheiten, Universitätsklinikum Münster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.
  • Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.
  • Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).
  • Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.
  • Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.
  • Signed informed consent form after the nature of the study has been fully explained.

Exclusion Criteria:

  • Pregnancy or lactation and women with positive pregnancy test.
  • Known hypersensitivity or allergic contact reactions to components of the study agents.
  • Treatment with photosensitizing drugs.
  • Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.
  • History of another photodermatosis, except polymorph light eruption (PLE).
  • Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.
  • Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.
  • Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient
  • Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.
  • Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.
  • Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:
  • Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion;
  • Renal disorder: proteinuria greater than 0.5 g/d or greater than 3+, or cellular casts;
  • Neurologic disorder: seizures or psychosis without other cause.
  • Patients with a documented HIV and/or hepatitis B or C infection.
  • Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sunscreens with a low, medium, high SPF
sunscreens with a low, medium, and high SPF. UVA and UVB irradiation
Other: UV A and B irradiation
UV irradiation
Experimental: vehicle
Intra-individual application of vehicle in random order; UVA and UVB irradiation
Other: UV A and B irradiation
UV irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE
Time Frame: September 2011
September 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spirig Pharma Ltd.

Investigators

  • Principal Investigator: Annegret Kuhn, MD, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DL0814-SPRG0801/KHMR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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