Sunscreen and After-sun-lotion Protection in Polymorphic Light Eruption
The Efficacy of a Sunscreen With SPF30 and a After-sun-lotion in the Prevention of Polymorphic Light Eruption
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 24, 2007
CompletedFirst Posted
Study publicly available on registry
October 26, 2007
CompletedSeptember 30, 2009
September 1, 2009
4 months
October 24, 2007
September 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of symptoms of polymorphic light eruption
Prospective
Secondary Outcomes (5)
Pruritus
Prospective
Skin infiltration
prospective
Area affected
prospective
Erythema
prospective
Tanning
Prospective
Interventions
2 mg/cm2 immediately after UV exposure
2mg/cm2 immediately after UV exposure
Eligibility Criteria
You may qualify if:
- Diagnosis of PLE either by typical history and/or typical histology of lesions and/or positive phototesting results
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz, Department of Dermatology
Graz, A-8036, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Wolf, MD
Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 24, 2007
First Posted
October 26, 2007
Study Start
February 1, 2004
Primary Completion
June 1, 2004
Study Completion
August 1, 2006
Last Updated
September 30, 2009
Record last verified: 2009-09