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CompletedNCT00555633Updated Sep 30, 2009

Use of an SPF30 Sunscreen and an After-sun-lotion in Skin Cancer Risk Patients

An observational study in Skin Cancer, Xeroderma Pigmentosum and Basal Cell Nevus Syndrome, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2009-09-30.

Sponsored by Medical University of Graz · Observational

Study type
Observational
Enrollment
13
Ages
19 Years and older
Sex
All
01

Study 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.

Read the detailed description

An SPF 30 sunscreen and a proprietary after sun lotion both containing a combination of plankton extract and micrococcus lysate (kindly provided by ATEIA AG, Vaduz, Liechtenstein) was used in a pilot study of intensified photoprotection in patients with multiple skin cancers. Thirteen patients (8 women and 5 men), between 37 and 81 years old, who had had a history of multiple skin cancers were enrolled in the study. Five of the patients had xeroderma pigmentosum (XP) (complementation group: A, 2; C,1; and non-classified 2); one patient XP variant, 3 patients basal cell nevus syndrome, and four patients no skin cancer syndrome. Patients were instructed to apply their sunscreen regularly before sun exposure and 4.5 ml of the after sun lotion to their face and arms daily, as close to mid-day as possible for a period of up to 24 months. The patients were examined in 3-month intervals and the new appearance of actinic keratoses and skin cancers was recorded. New lesions were removed at these visits and the pathology was confirmed by histological examination, except in the cases of (multiple) actinic keratoses, whenever patients agreed. The number of skin tumors during the 24 months of the study was compared to the number in the preceding 24 month-period before study entry. The data were obtained from patient charts and/or electronic files. There was a statistical trend for less BCCs during the study period compared to the prestudy period. In addition, the patients received at each of the 3-month visits a questionnaire and were asked to rate the status of their skin on face and arms during the last 3 months for various parameters on a scale from -2 (maximum worsening) to +2 (maximum improvement). The patients' ratings revealed a statistically significant improvement for several parameters: smoothness, color spots, wrinkles, burning, irritation, teleangiectasia, infections, warts, and skin lesions or sores, starting as early than at the first 3-month visit with a maximum effect seen at 12 months. No adverse effects were noted during the study.

02

Conditions studied

  • Skin Cancer
  • Xeroderma Pigmentosum
  • Basal Cell Nevus Syndrome

Keywords

  • Photoprotection
  • Sunscreen
  • After-sun-lotion
  • DNA repair enzymes
  • liposomes
  • skin cancer
  • Xeroderma pigmentosum
  • Basal cell nevus syndrome
03

In context

Skin Neoplasms

591 studies on the registry are indexed under Skin Neoplasms; 115 are open to participants now.

This study's enrollment of 13 is below the median of 182 across 136 observational studies indexed under Skin Neoplasms.

Browse Skin Neoplasms studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 470 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Intolerance of study preparation
  • Allergy against study preparation
  • Non-acceptable side effects
05

Study design

Enrollment
13 participants (actual)
06

What researchers measure

Primary outcomes

  1. Number of skin cancers

    Time frame: retrospective

Secondary outcomes

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

    Time frame: retrospective

07

Study locations

1 site
  • Medical University of Graz, Department of Dermatology
    Graz, A-8036, Austria
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00555633
First posted
Nov 8, 2007
Start date
Oct 2004
Completion
Feb 2006
Last update
Sep 30, 2009

Study contacts

Peter Wolf, MD
principal investigator · Medical University of Graz

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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