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Completed

NCT Number: NCT00549588

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz, Department of Dermatology

Graz, A-8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

After-sun-lotion with DNA repair enzymes

Other

2 mg/cm2 immediately after UV exposure

Other names: Proprietary after-sun lotion (Ateia Inc.)

SPF30 sunscreen

Other

2 mg/cm2 2o min before UV exposure

Other names: SPF30 sunscreen (Ateia Inc.)

Placebo after-sun-lotion

Other

2mg/cm2 immediately after UV exposure

Other names: Proprietary after sun lotion vehicle (Ateia Inc.)

Intervention: none (only UV)

Other

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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

The Efficacy of a Sunscreen With SPF30 and a After-sun-lotion in the Prevention of Polymorphic Light Eruption

Important dates

Study start
2004
Primary completion
2004
Study completion
2006
First posted
Oct 26, 2007
Registry last updated
Sep 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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