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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00549588
First received: October 24, 2007
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Polymorphic Light Eruption
Other: After-sun-lotion with DNA repair enzymes
Other: SPF30 sunscreen
Other: Placebo after-sun-lotion
Other: Intervention: none (only UV)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of a Sunscreen With SPF30 and a After-sun-lotion in the Prevention of Polymorphic Light Eruption

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Occurrence of symptoms of polymorphic light eruption [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pruritus [ Time Frame: Prospective ] [ Designated as safety issue: No ]
  • Skin infiltration [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Area affected [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Erythema [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Tanning [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: February 2004
Study Completion Date: August 2006
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: After-sun-lotion with DNA repair enzymes
    2 mg/cm2 immediately after UV exposure
    Other Name: Proprietary after-sun lotion (Ateia Inc.)
    Other: SPF30 sunscreen
    2 mg/cm2 2o min before UV exposure
    Other Name: SPF30 sunscreen (Ateia Inc.)
    Other: Placebo after-sun-lotion
    2mg/cm2 immediately after UV exposure
    Other Name: Proprietary after sun lotion vehicle (Ateia Inc.)
    Other: Intervention: none (only UV)
    n.a.
    Other Name: n.a.
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549588

Locations
Austria
Medical University of Graz, Department of Dermatology
Graz, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Peter Wolf, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria
ClinicalTrials.gov Identifier: NCT00549588     History of Changes
Other Study ID Numbers: 14-058 ex 03/04
Study First Received: October 24, 2007
Last Updated: September 29, 2009
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Graz:
Polymorphic light eruption
UV radiation
photoprotection
sunscreen
DNA repair enzymes
after-sun-lotion

Additional relevant MeSH terms:
Exanthema
Dermatitis, Contact
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014