Trial record 4 of 7 for:    "xeroderma pigmentosum"

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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00555633
First received: November 7, 2007
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Number of skin cancers [ Time Frame: retrospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients' skin score parameters (including smoothness, color spots, wrinkles, burning, irritation, teleangiectasia, infections, warts, and skin lesions or sores) [ Time Frame: retrospective ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: October 2004
Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555633

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

No publications provided

Responsible Party: Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria
ClinicalTrials.gov Identifier: NCT00555633     History of Changes
Other Study ID Numbers: 16-015 ex 04/05
Study First Received: November 7, 2007
Last Updated: September 29, 2009
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Graz:
Photoprotection
Sunscreen
After-sun-lotion
DNA repair enzymes
liposomes
skin cancer
Xeroderma pigmentosum
Basal cell nevus syndrome

Additional relevant MeSH terms:
Xeroderma Pigmentosum
Basal Cell Nevus Syndrome
Skin Neoplasms
Nevus
Nevus, Pigmented
Ichthyosis
Odontogenic Cysts
Jaw Cysts
Bone Cysts
Cysts
Neoplasms
Carcinoma, Basal Cell
Carcinoma
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
Neoplasms by Site
Skin Diseases
Nevi and Melanomas
Skin Abnormalities
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 24, 2014