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

Polymorphic Light Eruption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549588
• Other study ID #: 14-058 ex 03/04
• Status: Completed
• Phase: N/A
• First received: October 24, 2007
• Last updated: September 29, 2009
• Start date: February 2004
• Est. completion date: August 2006

Study information

• Verified date: September 2009
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2006
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dermatitis, Contact
• Exanthema
• Polymorphic Light Eruption

Intervention

Other:
• After-sun-lotion with DNA repair enzymes
2 mg/cm2 immediately after UV exposure
• SPF30 sunscreen
2 mg/cm2 2o min before UV exposure
• Placebo after-sun-lotion
2mg/cm2 immediately after UV exposure
• Intervention: none (only UV)
n.a.

Locations

Country	Name	City	State
Austria	Medical University of Graz, Department of Dermatology	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of symptoms of polymorphic light eruption		Prospective	No
Secondary	Pruritus		Prospective	No
Secondary	Skin infiltration		prospective	No
Secondary	Area affected		prospective	No
Secondary	Erythema		prospective	No
Secondary	Tanning		Prospective	No