CompletedNCT01571336Updated Sep 27, 2016

Photodynamic Therapy of Actinic Keratoses With Alacare®

An observational study in Actinic Keratosis, sponsored by photonamic GmbH & Co. KG. Completed at 8 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-27.

Sponsored by photonamic GmbH & Co. KG · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 388
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Actinic Keratosis

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In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 388 is above the median of 179 across 35 observational studies indexed under Keratosis, Actinic.

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Lead sponsor

photonamic GmbH & Co. KG is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Community sample

Eligibility criteria

Inclusion Criteria:

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

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 388 participants (actual)

What researchers measure

Primary outcomes

Number of SCCs in areas treated with Alacare®-PDT
Time frame: Two years after Alacare®-PDT

Study locations

8 sites

Medizinisches Zentrum Bonn Friedensplatz
Bonn, 53111, Germany
Hautarztpraxis Prof. Kurzen
Freising, 85354, Germany
Hautärztliche Gemeinschaftspraxis Dr. med. Peter Dworzak Dr. med. Peter Radny
Friedrichshafen, 88045, Germany
Gemeinschaftspraxis Dres.Ina Röhrig-Petering und Holger Petering
Hildesheim, 31134, Germany
Dermatologische Gemeinschaftspraxis Prof. Dr. J. Gille & Dr. K. Spieth-Gille
Königstein im Taunus, 61462, Germany
ZENTderma
Mönchengladbach, 41061, Germany
Facharzt für Haut- und Geschlechtskrankheiten
Radolfzell, 78315, Germany
Praxis Prof. Dr. Thomas Dirschka
Wuppertal, 42275, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01571336
Lead sponsor: photonamic GmbH & Co. KG
Responsible party: Sponsor
First posted: Apr 5, 2012
Start date: Apr 2012
Primary completion: May 2016
Completion: Sep 2016
Last update: Sep 27, 2016

Study contacts

Peter Radny, MD

study chair · Dermatological group practice, Charlottenstraße 12, D-88045 Friedrichshafen, Germany

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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