Skin CancerNCT00555633
Use of an SPF30 Sunscreen and an After-sun-lotion in Skin Cancer Risk Patients
An observational study of Skin Cancer and Xeroderma Pigmentosum, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Skin Cancer, Xeroderma Pigmentosum, Basal Cell Nevus Syndrome
- How many people
- 13 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2004to Feb 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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)
Who cannot join
- Intolerance of study preparation
- Allergy against study preparation
- Non-acceptable side effects
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department of Dermatology
Graz, A-8036
About this study
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 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.
Read the 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.
- Keywords
- Photoprotection, Sunscreen, After-sun-lotion, DNA repair enzymes, liposomes, skin cancer, Xeroderma pigmentosum, Basal cell nevus syndrome
- Medical subject headings
- Skin Neoplasms, Xeroderma Pigmentosum, Basal Cell Nevus Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of skin cancers
Measured: retrospective
Secondary outcomes (1)
Patients' skin score parameters (including smoothness, color spots, wrinkles, burning, irritation, teleangiectasia, infections, warts, and skin lesions or sores)
Measured: retrospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startOct 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Peter Wolf, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555633
- Sponsor's protocol ID
- 16-015 ex 04/05
- Status last verified
- Sep 2009
- First submitted
- 7 Nov 2007
- Last updated
- 30 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00555633
- Acronym / sponsor ID
- 16-015 ex 04/05
- Keywords
- Photoprotection, Sunscreen, After-sun-lotion, DNA repair enzymes, liposomes, skin cancer, Xeroderma pigmentosum, Basal cell nevus syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 8 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Intolerance of study preparation
- Allergy against study preparation
- Non-acceptable side effects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of skin cancers
Time frame: retrospective
1 secondary outcome
Patients' skin score parameters (including smoothness, color spots, wrinkles, burning, irritation, teleangiectasia, infections, warts, and skin lesions or sores)
Time frame: retrospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Wolf, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer and Xeroderma Pigmentosum, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of skin cancers (time frame: retrospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2009.