Actinic KeratosisNCT01571336
Photodynamic Therapy of Actinic Keratoses With Alacare®
An observational study of Actinic Keratosis, run by photonamic GmbH & Co. KG at 8 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- How many people
- 388 participants
- Where
- 8 sitesGermany
- Study dates
- Apr 2012to Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Medizinisches Zentrum Bonn Friedensplatz
Bonn, 53111
Hautarztpraxis Prof. Kurzen
Freising, 85354
Hautärztliche Gemeinschaftspraxis Dr. med. Peter Dworzak Dr. med. Peter Radny
Friedrichshafen, 88045
Gemeinschaftspraxis Dres.Ina Röhrig-Petering und Holger Petering
Hildesheim, 31134
Dermatologische Gemeinschaftspraxis Prof. Dr. J. Gille & Dr. K. Spieth-Gille
Königstein im Taunus, 61462
ZENTderma
Mönchengladbach, 41061
Facharzt für Haut- und Geschlechtskrankheiten
Radolfzell, 78315
Praxis Prof. Dr. Thomas Dirschka
Wuppertal, 42275
About this study
Official title: Non-interventional Observational Study on Photodynamic Therapy of Actinic Keratoses With Alacare®
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
- Actinic Keratosis
- Medical subject headings
- Keratosis, Actinic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of SCCs in areas treated with Alacare®-PDT
Measured: Two years after Alacare®-PDT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- photonamic GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Radny, MD, Study chair, Dermatological group practice, Charlottenstraße 12, D-88045 Friedrichshafen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571336
- Sponsor's protocol ID
- NIS 01
- Status last verified
- Sep 2016
- First submitted
- 3 Apr 2012
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Observational Study on Photodynamic Therapy of Actinic Keratoses With Alacare®
- ClinicalTrials.gov ID
- NCT01571336
- Acronym / sponsor ID
- NIS 01
- Conditions
- Actinic Keratosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- photonamic GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Apr 2012 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
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 SCCs in areas treated with Alacare®-PDT
Time frame: Two years after Alacare®-PDT
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 27 Sep 2016.
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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 Radny, MD study chair
Dermatological group practice, Charlottenstraße 12, D-88045 Friedrichshafen, Germany
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratosis, run by photonamic GmbH & Co. KG at 8 sites in Germany.
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 2 inclusion and 0 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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 SCCs in areas treated with Alacare®-PDT (time frame: Two years after Alacare®-PDT). 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 27 Sep 2016.