Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)

Cutaneous Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146444
• Other study ID #: DL0814-SPRG0801/KHMR
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: March 8, 2016
• Start date: November 2009
• Est. completion date: November 2012

Study information

• Verified date: December 2013
• Source: Spirig Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cutaneous Lupus Erythematosus
• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

Intervention

Other:
• UV A and B irradiation
UV irradiation

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Hautkrankheiten, Universitätsklinikum Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Spirig Pharma Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE		September 2011	No