NCT01776983

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

5.2 years

First QC Date

January 24, 2013

Last Update Submit

June 15, 2015

Conditions

Photosensitivity Disorders

Outcome Measures

Primary Outcomes (1)

  • 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

    One Time measurement at the one and only time point of inclusion and measurement

Interventions

Photosensitivity under the influence of immunocompDEVICE

Siascopy measurement of reflected light

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

individuals between 18 and 90 years of age

You may qualify if:

  • Renal transplant recipients transplanted more than seven years ago and immunocompetent probands of the same age.

You may not qualify if:

  • Refusal of informed consent, physical or psychological inability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Department of Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 25307045RESULT

MeSH Terms

Conditions

Photosensitivity Disorders

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Günther Hofbauer, MD

    University Hospital Zurich, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 28, 2013

Study Start

September 1, 2008

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

CH(1)