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Trial record 77 of 537 for:    "Skin cancer"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00555633
Recruitment Status : Completed
First Posted : November 8, 2007
Last Update Posted : September 30, 2009
Information provided by:
Medical University of Graz

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.

Condition or disease
Skin Cancer Xeroderma Pigmentosum 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.

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Study Type : Observational
Actual Enrollment : 13 participants
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 Start Date : October 2004
Actual Study Completion Date : February 2006

Primary Outcome Measures :
  1. Number of skin cancers [ Time Frame: retrospective ]

Secondary Outcome Measures :
  1. Patients' skin score parameters (including smoothness, color spots, wrinkles, burning, irritation, teleangiectasia, infections, warts, and skin lesions or sores) [ Time Frame: retrospective ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00555633

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Medical University of Graz, Department of Dermatology
Graz, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
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Principal Investigator: Peter Wolf, MD Medical University of Graz, Austria

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Responsible Party: Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria Identifier: NCT00555633     History of Changes
Other Study ID Numbers: 16-015 ex 04/05
First Posted: November 8, 2007    Key Record Dates
Last Update Posted: September 30, 2009
Last Verified: September 2009

Keywords provided by Medical University of Graz:
DNA repair enzymes
skin cancer
Xeroderma pigmentosum
Basal cell nevus syndrome

Additional relevant MeSH terms:
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Skin Neoplasms
Basal Cell Nevus Syndrome
Xeroderma Pigmentosum
Pathologic Processes
Neoplasms by Site
Skin Diseases
Odontogenic Cysts
Jaw Cysts
Bone Cysts
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplastic Syndromes, Hereditary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Stomatognathic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Skin Abnormalities
Infant, Newborn, Diseases