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Sponsored by: |
Medical University of Graz |
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Information provided by: | Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT00555633 |
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.
Condition |
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Skin Cancer Xeroderma Pigmentosum Basal Cell Nevus Syndrome |
Study Type: | Observational |
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 |
Enrollment: | 13 |
Study Start Date: | October 2004 |
Study Completion Date: | February 2006 |
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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Primary care clinic
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Medical University of Graz, Department of Dermatology | |
Graz, Austria, A-8036 |
Principal Investigator: | Peter Wolf, MD | Medical University of Graz, Austria |
Responsible Party: | Medical University of Graz, Austria ( Peter Wolf, MD, Principal Investigator ) |
Study ID Numbers: | 16-015 ex 04/05 |
Study First Received: | November 7, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00555633 |
Health Authority: | Austria: Federal Ministry for Health and Women |
Photoprotection Sunscreen After-sun-lotion DNA repair enzymes |
liposomes skin cancer Xeroderma pigmentosum Basal cell nevus syndrome |
Keratosis Photosensitivity Disorders Precancerous Conditions Bone Diseases Ichthyosis Melanoma Nevoid basal cell carcinoma syndrome Basal Cell Nevus Syndrome Musculoskeletal Diseases Nevus, Pigmented Bone Cysts Bone Diseases, Developmental Abnormalities, Multiple Infant, Newborn, Diseases Congenital Abnormalities |
Skin Diseases, Genetic Xeroderma Pigmentosum Metabolic Diseases Skin Diseases Pigmentation Disorders Keratosis follicularis spinulosa decalvans Skin Abnormalities Carcinoma, Basal Cell Lamellar ichthyosis Cysts Skin Neoplasms Carcinoma Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Nevus |
Neoplasms Odontogenic Cysts Pathologic Processes Disease Neoplasms by Site Neoplasms by Histologic Type |
Syndrome DNA Repair-Deficiency Disorders Jaw Diseases Neoplasms, Basal Cell Nevi and Melanomas Jaw Cysts |