NCT00555633

Brief Summary

Study aim: To determine the effect of an intensified daily photoprotection over 24 months with an SPF30 sunscreen and an after sun-lotion both containing liposomal DNA repair enzymes in a population of patients at high-risk for skin cancer, including xeroderma pigmentosum (XP) and basal cell nevus syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2007

Completed
Last Updated

September 30, 2009

Status Verified

September 1, 2009

First QC Date

November 7, 2007

Last Update Submit

September 29, 2009

Conditions

Skin CancerXeroderma PigmentosumBasal Cell Nevus Syndrome

Keywords

PhotoprotectionSunscreenAfter-sun-lotionDNA repair enzymesliposomesskin cancerXeroderma pigmentosumBasal cell nevus syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of skin cancers

    retrospective

Secondary Outcomes (1)

  • Patients' skin score parameters (including smoothness, color spots, wrinkles, burning, irritation, teleangiectasia, infections, warts, and skin lesions or sores)

    retrospective

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • Xeroderma pigmentosum
  • Basal cell nevus syndrome
  • Other patient with a history of multiple skin cancers (three or more lesions, including actinic keratosis, squamous cell carcinoma, basal cell carcinoma, and/or malignant melanoma)

You may not qualify if:

  • Intolerance of study preparation
  • Allergy against study preparation
  • Non-acceptable side effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz, Department of Dermatology

Graz, A-8036, Austria

Location

MeSH Terms

Conditions

Skin NeoplasmsXeroderma PigmentosumBasal Cell Nevus Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesPrecancerous ConditionsSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornPhotosensitivity DisordersPigmentation DisordersDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOdontogenic CystsJaw CystsBone CystsCystsCarcinoma, Basal CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Basal CellNeoplastic Syndromes, HereditaryBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesJaw DiseasesStomatognathic DiseasesAbnormalities, Multiple

Study Officials

  • Peter Wolf, MD

    Medical University of Graz, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 8, 2007

Study Start

October 1, 2004

Study Completion

February 1, 2006

Last Updated

September 30, 2009

Record last verified: 2009-09

Locations

AU(1)