NCT01571336

Brief Summary

This study aims to collect data on the frequency of SCCs in the Alacare®-treated area during an interval of two years after Alacare®-PDT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
388

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

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

April 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

4.1 years

First QC Date

April 3, 2012

Last Update Submit

September 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of SCCs in areas treated with Alacare®-PDT

    Two years after Alacare®-PDT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample

You may qualify if:

  • Written informed consent
  • Patients with 3 to 6 mild AK lesions on the hairless areas of the head and face which were treated with Alacare®-PDT according to the SPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Medizinisches Zentrum Bonn Friedensplatz

Bonn, 53111, Germany

Location

Hautarztpraxis Prof. Kurzen

Freising, 85354, Germany

Location

Hautärztliche Gemeinschaftspraxis Dr. med. Peter Dworzak Dr. med. Peter Radny

Friedrichshafen, 88045, Germany

Location

Gemeinschaftspraxis Dres.Ina Röhrig-Petering und Holger Petering

Hildesheim, 31134, Germany

Location

Dermatologische Gemeinschaftspraxis Prof. Dr. J. Gille & Dr. K. Spieth-Gille

Königstein im Taunus, 61462, Germany

Location

ZENTderma

Mönchengladbach, 41061, Germany

Location

Facharzt für Haut- und Geschlechtskrankheiten

Radolfzell, 78315, Germany

Location

Praxis Prof. Dr. Thomas Dirschka

Wuppertal, 42275, Germany

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Peter Radny, MD

    Dermatological group practice, Charlottenstraße 12, D-88045 Friedrichshafen, Germany

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 5, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations