Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spirig Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01146444
First received: May 24, 2010
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Cutaneous Lupus Erythematosus
Other: Daylong products

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Investigation of the Efficacy of Different Sunscreens in Patients With Photosensitive Cutaneous Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Spirig Pharma Ltd.:

Primary Outcome Measures:
  • Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE [ Time Frame: September 2011 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: November 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunscreens Other: Daylong products
topical: 2 mg/cm2
Other Name: Sunscreens with low, medium and high SFP

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146444

Locations
Germany
Klinik und Poliklinik für Hautkrankheiten, Universitätsklinikum Münster
Münster, Germany, 48149
Sponsors and Collaborators
Spirig Pharma Ltd.
Investigators
Principal Investigator: Annegret Kuhn, MD Professor
  More Information

No publications provided

Responsible Party: Spirig Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01146444     History of Changes
Other Study ID Numbers: DL0814-SPRG0801/KHMR
Study First Received: May 24, 2010
Last Updated: December 4, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Spirig Pharma Ltd.:
Sunscreening Agents

Additional relevant MeSH terms:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014