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

Primary Purpose

Skin Cancer, Xeroderma Pigmentosum, Basal Cell Nevus Syndrome

Status
Completed
Phase
Locations
Austria
Study Type
Observational
Intervention
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Skin Cancer focused on measuring Photoprotection, Sunscreen, After-sun-lotion, DNA repair enzymes, liposomes, skin cancer, Xeroderma pigmentosum, Basal cell nevus syndrome

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Medical University of Graz, Department of Dermatology

Outcomes

Primary Outcome Measures

Number of skin cancers

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2007
Last Updated
September 29, 2009
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT00555633
Brief Title
Use of an SPF30 Sunscreen and an After-sun-lotion in Skin Cancer Risk Patients
Official Title
Regular Use of an SPF30 Sunscreen and an After-sun-lotion in Skin Cancer Risk Patients, Particularly in Xeroderma Pigmentosum and Basal Cell Nevus Syndrome
Study Type
Observational

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Enrollment
13 (Actual)
Primary Outcome Measure Information:
Title
Number of skin cancers
Time Frame
retrospective
Secondary Outcome Measure Information:
Title
Patients' skin score parameters (including smoothness, color spots, wrinkles, burning, irritation, teleangiectasia, infections, warts, and skin lesions or sores)
Time Frame
retrospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Intolerance of study preparation Allergy against study preparation Non-acceptable side effects
Study Population Description
Primary care clinic
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Wolf, MD
Organizational Affiliation
Medical University of Graz, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz, Department of Dermatology
City
Graz
ZIP/Postal Code
A-8036
Country
Austria

12. IPD Sharing Statement

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

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