CompletedNot Applicable

Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)

Germany20 participantsStarted 2009-11

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: September 2011

Trial details

NCT IDNCT01146444

SponsorSpirig Pharma Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-09

View on ClinicalTrials.gov More Cutaneous Lupus Erythematosus trials