Photosensitivity DisordersNCT01776983
Skin Aging in Renal Transplant Patients
An observational study of Photosensitivity Disorders, run by University of Zurich at 1 site in Switzerland.
Trial summary
Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients. Trial in the field of transplantation / xenotransplantation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Photosensitivity Disorders
- What is being tested?
- Photosensitivity under the influence of immunocomp
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2008to Jan 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: individuals between 18 and 90 years of age
Who may be able to join
- Renal transplant recipients transplanted more than seven years ago and immunocompetent probands of the same age.
Who cannot join
- Refusal of informed consent, physical or psychological inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Department of Dermatology
Zurich, Canton of Zurich, 8091
About this study
Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients.
- Trial in the field of transplantation / xenotransplantation
Read the detailed description
Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients.
- Conditions
- Photosensitivity Disorders
- Being tested
- Photosensitivity under the influence of immunocomp
- Medical subject headings
- Photosensitivity Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photosensitivity under the influence of immunocompDevice
Siascopy measurement of reflected light
What is being measured
The primary outcome is the main question the study is designed to answer.
skin aging defined by melanin, collagen and hemoglobin content
there is only one time point for measurement, there is no "time frame", just one single measurement per patient at the one and only visit
Measured: One Time measurement at the one and only time point of inclusion and measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startSep 2008
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Photosensitivity DisordersStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational model
- Cohort
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Günther Hofbauer, MD, Principal investigator, University Hospital Zurich, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776983
- Sponsor's protocol ID
- 2008SIA01
- Status last verified
- Jun 2015
- First submitted
- 24 Jan 2013
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stimpfle DW, Serra AL, Wuthrich RP, French LE, Braun RP, Hofbauer GF. Spectophotometric intracutaneous analysis: an investigation on photodamaged skin of immunocompromised patients. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1141-7. doi: 10.1111/jdv.12771. Epub 2014 Oct 13.
PubMed 25307045
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Aging in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT01776983
- Acronym / sponsor ID
- 2008SIA01
- Conditions
- Photosensitivity Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Jan 2013 (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.
Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients.
- Trial in the field of transplantation / xenotransplantation
Detailed description
Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients.
Study design
- Observational model
- Cohort
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- individuals between 18 and 90 years of age
Key inclusion criteria (1 listed)
- Renal transplant recipients transplanted more than seven years ago and immunocompetent probands of the same age.
Key exclusion criteria (1 listed)
- Refusal of informed consent, physical or psychological inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photosensitivity under the influence of immunocompSiascopy measurement of reflected light | Device | – |
Primary outcome
skin aging defined by melanin, collagen and hemoglobin content
Time frame: One Time measurement at the one and only time point of inclusion and measurement
there is only one time point for measurement, there is no "time frame", just one single measurement per patient at the one and only visit
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 16 Jun 2015.
- Results publication: PubMed 25307045Stimpfle DW, Serra AL, Wuthrich RP, French LE, Braun RP, Hofbauer GF. Spectophotometric intracutaneous analysis: an investigation on photodamaged skin of immunocompromised patients. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1141-7. doi: 10.1111/jdv.12771. Epub 2014 Oct 13.
Related trials for Photosensitivity Disorders
RecruitingObservational study
Skin Type Determination Using Image Artificial Intelligence
Skin Ageing, Skin
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Not yet recruiting
Randomized Trial of a Sun Safety Intervention for Young Adults
Sunburn
Active, not recruitingPhase 3
Undergraduate Skin Cancer Prevention Trial
Skin Cancer
RecruitingObservational study
Natural History Study for DNA Repair Disorders
DNA Repair Disorder, Cockayne Syndrome
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.
Günther Hofbauer, MD principal investigator
University Hospital Zurich, Department of Dermatology
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 Photosensitivity Disorders, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 1 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 16 Jun 2015. 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 Switzerland. 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?
skin aging defined by melanin, collagen and hemoglobin content (time frame: One Time measurement at the one and only time point of inclusion and measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01776983, which also lists 1 linked publication.
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 16 Jun 2015.