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CompletedNCT00549588Updated Sep 30, 2009

Sunscreen and After-sun-lotion Protection in Polymorphic Light Eruption

An interventional study of After-sun-lotion with DNA repair enzymes and SPF30 sunscreen in Polymorphic Light Eruption, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2009-09-30.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Polymorphic light eruption (PLE) is a common photodermatosis characterized by the appearance of itching, erythema, papules or vesicles on sun-exposed skin. Though etiology is unclear it is hypothesized that it is an abnormal immune response to autologous antigens generated by ultraviolet radiation (UVR). This randomized, double blinded left-right body side experimental comparison study was designed to assess the preventive effect of a sunscreen and topical DNA repair enzyme-containing after-sun lotion in PLE.

Read the detailed description

A SPF 30 sunscreen (containing chemical and physical UV filters), an after-sun lotion containing liposomal encapsulated micrococcus luteus lysate with endonuclease activity and photolyase (active AS), and an after-sun placebo formulation (containing no DNA repair enzymes) (placebo AS) has been used in this study. Fourteen PLE patients were enrolled. On day 1, the individual minimal erythema dose (MED) was assessed on patients' buttock skin by exposure to a test ladder of solar-simulated UVR (xenon arc source, Oriel Corp. Darmstadt, Germany). From day 2 to 5, 0.75 individual MED exposures (increased by 0 to 25% per exposure, depending on the erythema response to a preceding dose) were given to a total of four 5-by-5 cm skin test fields on symmetrically located, individual PLE predilection sites on the trunk or extremities. The test fields were treated in randomized and double-blinded fashion either with SPF30 sunscreen 20 min before UVR exposure, active AS or placebo AS (all creams at a concentration of 2mg/cm2) immediately after UVR exposure, or left untreated. Sixty minutes after UVR exposure all test areas were treated with visible light (400 to 450nm, 5J/cm2) to activate the light dependent photolyase DNA repair mechanism. The photo test procedure led to the appearance of PLE symptoms in unprotected test fields of 12/14 (86%) patients, active AS-treated test fields of 6/14 (43%) patients (p\<0.05), placebo AS-treated test fields of 10/14 (71%) patients (p, ns), and no (0%) sunscreen-protected test fields of any patient (p\<0.0001 vs. unprotected test fields, Fisher exact test). These results provide evidence that i) DNA damage is a trigger of PLE, ii) increasing DNA repair can prevent induction of PLE symptoms, and iii) the use of sun care preparations containing DNA repair enzymes may be clinically useful for PLE patients.

02

Conditions studied

  • Polymorphic Light Eruption

Keywords

  • Polymorphic light eruption
  • UV radiation
  • photoprotection
  • sunscreen
  • DNA repair enzymes
  • after-sun-lotion
03

In context

Exanthema

79 studies on the registry are indexed under Exanthema; 12 are open to participants now.

This study's enrollment of 14 is below the median of 42 across 58 interventional studies indexed under Exanthema.

Browse Exanthema studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 101 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of PLE either by typical history and/or typical histology of lesions and/or positive phototesting results

Exclusion criteria

Exclusion Criteria:

  • Presence of or history of malignant skin tumors
  • Dysplastic melanocytic nevus syndrome
  • Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
  • Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
  • Psychiatric disorders
  • Systemic treatment with steroids and/or other immunosuppressive drugs
  • Pregnancy or lactation
  • Antinuclear antibodies
  • UV exposure in test fields within 8 weeks before study start
  • General poor health status
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
14 participants (actual)

Interventions

  • OtherAfter-sun-lotion with DNA repair enzymes

    2 mg/cm2 immediately after UV exposure

    Also known as: Proprietary after-sun lotion (Ateia Inc.)

  • OtherSPF30 sunscreen

    2 mg/cm2 2o min before UV exposure

    Also known as: SPF30 sunscreen (Ateia Inc.)

  • OtherPlacebo after-sun-lotion

    2mg/cm2 immediately after UV exposure

    Also known as: Proprietary after sun lotion vehicle (Ateia Inc.)

  • OtherIntervention: none (only UV)
06

What researchers measure

Primary outcomes

  1. Occurrence of symptoms of polymorphic light eruption

    Time frame: Prospective

Secondary outcomes

  1. Pruritus

    Time frame: Prospective

  2. Skin infiltration

    Time frame: prospective

  3. Area affected

    Time frame: prospective

  4. Erythema

    Time frame: prospective

  5. Tanning

    Time frame: Prospective

07

Study locations

1 site
  • Medical University of Graz, Department of Dermatology
    Graz, A-8036, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00549588
Lead sponsor
Medical University of Graz
First posted
Oct 26, 2007
Start date
Feb 2004
Primary completion
Jun 2004
Completion
Aug 2006
Last update
Sep 30, 2009

Study contacts

Peter Wolf, MD
principal investigator · Medical University of Graz

Oversight

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

Not currently enrolling

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