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CompletedNCT00470912Updated May 8, 2007

Sunscreen RV 2457C in Photoinduced CLE

A Phase 3 interventional study of sunscreen RV 2547C in Cutaneous Lupus Erythematosus, Skin Lesion and Experimental Photoinduction, sponsored by Heinrich-Heine University, Duesseldorf. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-05-08.

Sponsored by Heinrich-Heine University, Duesseldorf · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Lupus erythematosus (LE) is characterized by a large clinical spectrum, and sunligt is a well established factor in the induction and exacerbation of this disease. In all subsets of LE, skin lesions occur preferentially in sun-exposed areas.

Previous studies have demonstrated that the lesions in LE patients reproduced in controlled experimental conditions. The initial reports suggested that the action spectrum for the LE was in the UVB range (290 to 320 nm), but more recent studies have demonstrated that UVA (320 to 400 nm) can contribute to the induction of LE skin lesions.

Antimalarial agents and topical steroids are the main treatments of chronic LE. The second line therapies include retinoids, sulfones, immunosuppressor agents, systemic corticosteroid and thalidomide. Moreover, patients are advised to avoid sun, to wear sunprotective clothing and to apply sunscreen.

The aim of this study was to assess the efficacy of a sunscreen milk with high protection factor against UV-B and UV-A, used exclusively, in the photoinduced LE.

02

Conditions studied

  • Cutaneous Lupus Erythematosus
  • Skin Lesion
  • Experimental Photoinduction
  • Protective Sunscreen

Keywords

  • cutaneous lupus erythemaosus
  • photoprotection
  • photoprovocation
  • Sunscreen RV 2547C
03

In context

Lupus Erythematosus, Cutaneous

66 studies on the registry are indexed under Lupus Erythematosus, Cutaneous; 17 are open to participants now.

This study's enrollment of 25 is below the median of 31 across 56 interventional studies indexed under Lupus Erythematosus, Cutaneous.

Browse Lupus Erythematosus, Cutaneous studies →

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female subjects
  • Patient aged of 18 years or more
  • Documented medical history of chronic cutaneous lupus erythematosus (lupus erythematosus tumidus, discoid lupus erythematosus, subacute lupus erythematosus) without any sign of systematic involvement
  • patients who have a history of positive provocative phototestimg using a standardized protocol during a previous photobiologic exploration
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • Pregnant women, nursing mothers
  • subjects with lupus erythematosus with systematic involvement
  • subjects with a medical history of another photodermatosis
  • subjects with sun erythema, residual pigmentation, dermatological lesion, abnormal skin pigmentation which might interfere with a study evaluation on test sides
  • subjects who had sun solar simulator exposure on their backs within 12 weeks prior to enter to the study
  • subjects with a known intolarance to one of the formula compounds
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
25 participants (actual)

Interventions

  • Drugsunscreen RV 2547C
06

Study locations

1 site
  • Heinrich Heine University of Duesseldorf, Depatment of Dermatoly
    Duesseldorf, NRW 40225, Germany
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00470912
Lead sponsor
Heinrich-Heine University, Duesseldorf
First posted
May 8, 2007
Start date
May 2001
Completion
Feb 2002
Last update
May 8, 2007

Study contacts

Annegret Kuhn, MD
principal investigator · Heinrich-Heine University of Duesseldorf, Department of Dermatolgy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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