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

Skin Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555633
• Other study ID #: 16-015 ex 04/05
• Status: Completed
• Phase: N/A
• First received: November 7, 2007
• Last updated: September 29, 2009
• Start date: October 2004
• Est. completion date: February 2006

Study information

• Verified date: September 2009
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Basal Cell Nevus Syndrome
• Skin Cancer
• Skin Neoplasms
• Xeroderma Pigmentosum

Locations

Country	Name	City	State
Austria	Medical University of Graz, Department of Dermatology	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of skin cancers		retrospective	No
Secondary	Patients' skin score parameters (including smoothness, color spots, wrinkles, burning, irritation, teleangiectasia, infections, warts, and skin lesions or sores)		retrospective	No