NCT00549588

Completed

Sunscreen and After-sun-lotion Protection in Polymorphic Lig...

Medical University of Graz Source

Compare

Other study identifiers

Sponsor study identifier

14-058 ex 03/04

Study Type

interventional

Actual enrollment (reported)

14

Locations

1 country

Sites

1

Timeline

Study Start

February 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2004

Actual (reported)

Study Completion

August 2006

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 14 participants
Study completion date: August 2006
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2004
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2004
Actual (reported)
Study Completion
August 2006
Actual (reported)
First Submitted
October 24, 2007
Actual (reported)
First Posted
October 26, 2007
Actual (reported)

Last Updated: September 30, 2009
Status Verified: September 2009
Last Update Submitted: September 29, 2009

Conditions

Polymorphic Light Eruption

Keywords

Polymorphic light eruptionUV radiationphotoprotectionsunscreenDNA repair enzymesafter-sun-lotion

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

After-sun-lotion with DNA repair enzymesOther

2 mg/cm2 immediately after UV exposure

Also known as: Proprietary after-sun lotion (Ateia Inc.)

SPF30 sunscreenOther

2 mg/cm2 2o min before UV exposure

Also known as: SPF30 sunscreen (Ateia Inc.)

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

Medical University of Graz
Otherlead

Study Sites (1)

Medical University of Graz, Department of Dermatology

Graz, A-8036, Austria

MeSH Terms

Interventions

DNA Repair Enzymes

Intervention Hierarchy (Ancestors)

EnzymesEnzymes and Coenzymes

Study Officials

Peter Wolf, MD
Medical University of Graz
PRINCIPAL INVESTIGATOR

Enrollment

14 participants (actual enrollment reported by the registry).

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 2004

Date type not reported

This date has not been verified as actual or estimated.

NCT04704713

Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

Phase 3Completed

NCT03340155

Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases

Not ApplicableUnknown

NCT00555178

Regulatory T Cells (Tregs) in Polymorphic Light Eruption

Completed

Placebo after-sun-lotionOther

2mg/cm2 immediately after UV exposure

Also known as: Proprietary after sun lotion vehicle (Ateia Inc.)

Intervention: none (only UV)Other

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Primary Completion

June 2004

Actual (reported)

Study Completion

August 2006

Actual (reported)

Last Updated

September 30, 2009

Record last verified: 2009-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00549588
Data provider: ClinicalTrials.gov
Source updated: 2009-09-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:57 UTC

Locations

AT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations