Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)

Spirig Pharma

Status

Completed

Conditions

Cutaneous Lupus Erythematosus

Treatments

Other: UV A and B irradiation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01146444

DL0814-SPRG0801/KHMR

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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