Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)

NCT01146444 | Completed DMC

• 1 other identifier: DL0814-SPRG0801/KHMR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous Lupus Erythematosus

Keywords

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

• Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE

  September 2011

Study Arms (2)

sunscreens with a low, medium, high SPF

EXPERIMENTAL

sunscreens with a low, medium, and high SPF. UVA and UVB irradiation

Other: UV A and B irradiation

vehicle

EXPERIMENTAL

Intra-individual application of vehicle in random order; UVA and UVB irradiation

Other: UV A and B irradiation

Interventions

UV A and B irradiation OTHER

UV irradiation

sunscreens with a low, medium, high SPF; vehicle

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spirig Pharma Ltd.: lead

Study Sites (1)

Klinik und Poliklinik für Hautkrankheiten, Universitätsklinikum Münster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Annegret Kuhn, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: June 17, 2010
• Study Start: November 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2012
• Last Updated: March 9, 2016

Record last verified: 2013-12

Locations

DE (1)