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Cutaneous Lupus ErythematosusNCT01146444

Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)

A study testing UV A and B irradiation in people with Cutaneous Lupus Erythematosus, run by Spirig Pharma Ltd. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Cutaneous Lupus Erythematosus
What is being tested?
UV A and B irradiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGermany
Study dates
Nov 2009to Nov 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinik und Poliklinik für Hautkrankheiten, Universitätsklinikum Münster

    Münster, 48149

Other trials in Germany

About this study

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

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.

Read the 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.
Being tested
UV A and B irradiation
Keywords
Sunscreening Agents
Medical subject headings
Lupus Erythematosus, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UV A and B irradiationOther

    UV irradiation

Study groups in NCT01146444
Study groupRoleWhat they receive
sunscreens with a low, medium, high SPFExperimentalsunscreens with a low, medium, and high SPF. UVA and UVB irradiation
Receives: Other: UV A and B irradiation
vehicleExperimentalIntra-individual application of vehicle in random order; UVA and UVB irradiation
Receives: Other: UV A and B irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: September 2011

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionSep 2011
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01146444
Sponsor's protocol ID
DL0814-SPRG0801/KHMR
Status last verified
Dec 2013
First submitted
24 May 2010
Last updated
9 Mar 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing UV A and B irradiation in people with Cutaneous Lupus Erythematosus, run by Spirig Pharma Ltd. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevention of skin lesions following standardized photoprovokation with UVA/UVB light in patients with CLE (time frame: September 2011). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01146444.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.

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