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

Primary Purpose

Polymorphic Light Eruption

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
After-sun-lotion with DNA repair enzymes
SPF30 sunscreen
Placebo after-sun-lotion
Intervention: none (only UV)
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polymorphic Light Eruption focused on measuring Polymorphic light eruption, UV radiation, photoprotection, sunscreen, DNA repair enzymes, after-sun-lotion

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz, Department of Dermatology

Outcomes

Primary Outcome Measures

Occurrence of symptoms of polymorphic light eruption

Secondary Outcome Measures

Pruritus
Skin infiltration
Area affected
Erythema
Tanning

Full Information

First Posted
October 24, 2007
Last Updated
September 29, 2009
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT00549588
Brief Title
Sunscreen and After-sun-lotion Protection in Polymorphic Light Eruption
Official Title
The Efficacy of a Sunscreen With SPF30 and a After-sun-lotion in the Prevention of Polymorphic Light Eruption
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymorphic Light Eruption
Keywords
Polymorphic light eruption, UV radiation, photoprotection, sunscreen, DNA repair enzymes, after-sun-lotion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
After-sun-lotion with DNA repair enzymes
Other Intervention Name(s)
Proprietary after-sun lotion (Ateia Inc.)
Intervention Description
2 mg/cm2 immediately after UV exposure
Intervention Type
Other
Intervention Name(s)
SPF30 sunscreen
Other Intervention Name(s)
SPF30 sunscreen (Ateia Inc.)
Intervention Description
2 mg/cm2 2o min before UV exposure
Intervention Type
Other
Intervention Name(s)
Placebo after-sun-lotion
Other Intervention Name(s)
Proprietary after sun lotion vehicle (Ateia Inc.)
Intervention Description
2mg/cm2 immediately after UV exposure
Intervention Type
Other
Intervention Name(s)
Intervention: none (only UV)
Primary Outcome Measure Information:
Title
Occurrence of symptoms of polymorphic light eruption
Time Frame
Prospective
Secondary Outcome Measure Information:
Title
Pruritus
Time Frame
Prospective
Title
Skin infiltration
Time Frame
prospective
Title
Area affected
Time Frame
prospective
Title
Erythema
Time Frame
prospective
Title
Tanning
Time Frame
Prospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Wolf, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz, Department of Dermatology
City
Graz
ZIP/Postal Code
A-8036
Country
Austria

12. IPD Sharing Statement

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

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