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Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)

This study has been completed.
Information provided by (Responsible Party):
Spirig Pharma Ltd. Identifier:
First received: May 24, 2010
Last updated: March 8, 2016
Last verified: December 2013

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: UV A and B irradiation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

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 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

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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01146444

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

Responsible Party: Spirig Pharma Ltd. Identifier: NCT01146444     History of Changes
Other Study ID Numbers: DL0814-SPRG0801/KHMR
Study First Received: May 24, 2010
Last Updated: March 8, 2016

Keywords provided by Spirig Pharma Ltd.:
Sunscreening Agents

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents processed this record on May 25, 2017