Actinic KeratosisPhase 3NCT00308867
PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK
A Phase 3 study testing Photodynamic Therapy and Cryosurgery in people with Actinic Keratosis, run by photonamic GmbH & Co. KG at 26 sites in Germany.
Trial summary
The aim of this study is to investigate how the efficacy and tolerability of PD P 506 A-PDT relate to the commonly used cryosurgery in the treatment of mild to moderate AK lesions located on the head. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Photodynamic Therapy and Cryosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 349 participants
- Where
- 26 sitesGermany
- Study dates
- Mar 2006to Nov 2007
- Phase
- Phase 3
- 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
Who may be able to join
- Written informed consent
- Caucasians
- Age > 18 years
- Diagnosis of actinic keratosis (AK) with at least four locally separated lesions located on head and/or face (hairless areas)
- Selected AK study lesions have clearly defined margins and are mild to moderate (grades I or II)
- The distance between the study lesion borders is > 1.0 cm
- Maximum diameter of each study lesion is 1.8 cm
- Skin sun sensitivity type I to IV according to Fitzpatrick
Who cannot join
- PDT Non-responder
- Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding study treatment
- Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding study treatment with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
- Pre-treatment with hypericin during the 2 weeks preceding study therapy
- Treatment with systemic retinoids during the 3 months preceding study therapy
- Treatment with cytostatics or radiation during the 3 months preceding study therapy
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- Female patients of childbearing potential
- Patients with clinically relevant suppression of the immune system
- Diagnosis of Porphyria
- Skin diseases that might interfere with response evaluation of study treatment
- Skin sun sensitivity type V or VI according to Fitzpatrick
- Known intolerance to one or more of the ingredients of the study medication
- Known adverse reactions to cryosurgery (including cold urticaria and cold intolerance)
- Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
- Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
- Suspected lack of compliance
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Germany26 sites
Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber
Augsburg, 86179
Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin
Berlin, 10117
Praxis Dr. Simon
Berlin, 10827
Gemeinschaftspraxis Dres. Steinert
Biberach, 88400
Elbekliniken Dermatologisches Zentrum
Buxtehude, 21614
Gemeinschaftspraxis Dr. Dominicus, Dr. Bockhorst
Dülmen, 48249
Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin
Frankfurt a.M., 60590
Gemeinschaftspraxis Prof. Melnik, H. Hariry
Gütersloh, 33330
Gemeinschaftspraxis PD Dr. Petering, Dr. Röhrig-Petering
Hildesheim, 31134
Gemeinschaftspraxis Dr. Denzer-Fürst, Dr. Kietzmann
Kiel, 24103
Gemeinschaftspraxis Dr. Schirren, Dr. Lischner, Dr. Podszuweit
Kiel, 24103
Tagesklinik für Allergie- u. Hautkrankheiten
Kiel, 24148
Praxis Dr. Habermann
Koblenz, 56068
Praxis Dr. Fritz
Landau, 76829
Gemeinschaftspraxis PD Dr. Plötz, Prof. Dr. Abeck
München, 81545
Praxis Dr. Tanner
Nördlingen, 86720
Praxis Dr. Nickel
Pfungstadt, 64319
Praxis Dr. Itschert
Pinneberg, 25421
Praxis Dr. Rozsondai
Radolfzell, 78315
Praxis Dr. Gehse
Rastatt, 76437
Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie
Regensburg, 93053
Praxis Dr. Karl
Soest, 59494
Praxis Dr. Datz
Tübingen, 72072
Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch
Vechta, 49377
Praxis Dr. Imberger
Westerland, 25980
Praxis PD Dr. Dirschka
Wuppertal, 42275
About this study
Official title: Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis
The aim of this study is to investigate how the efficacy and tolerability of PD P 506 A-PDT relate to the commonly used cryosurgery in the treatment of mild to moderate AK lesions located on the head. To be able to quantify the effect the patient will be allocated to one of three treatments: PD P 506 A-PDT, cryosurgery or placebo-PDT.
Read the detailed description
Actinic keratosis (AK) is a pre-cancerous skin abnormality usually caused by sun exposure. Actinic keratoses occur most commonly in fair skin, especially in the elderly. They mainly occur in sun-exposed skin areas like head and hands. It is standard of care to remove AK when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (PDT). In Europe, cryosurgery is the method primarily used and will therefore serve as comparator therapy for PD P 506 A-PDT. A placebo control will be necessary to validate the test system. While the comparison of PD P 506 A-PDT and cryosurgery is an open comparison, placebo-PDT and PD P 506 A-PDT will be allocated in a double-blind manner.
- Conditions
- Actinic Keratosis
- Being tested
- Photodynamic Therapy, Cryosurgery
- Keywords
- PDT, AK, Cryosurgery
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic TherapyProcedure or surgery
CryosurgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment.
Measured: 12 weeks
Secondary outcomes (4)
CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment
Measured: 12 months
CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment
Measured: 12 months
Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy (PDT or cryosurgery)
Measured: 12 months
Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of no recurrence of the lesion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2007
- Study completionNov 2007
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- photonamic GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rolf-Marcus Szeimies, Professor MD, Principal investigator, Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308867
- Sponsor's protocol ID
- AK 04
- Other IDs
- EudraCT No. 2005-003556-36
- Status last verified
- Apr 2008
- First submitted
- 29 Mar 2006
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis
- ClinicalTrials.gov ID
- NCT00308867
- Acronym / sponsor ID
- AK 04
- Conditions
- Actinic Keratosis
- Keywords
- PDT, AK, Cryosurgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- photonamic GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 30 Mar 2006 (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.
The aim of this study is to investigate how the efficacy and tolerability of PD P 506 A-PDT relate to the commonly used cryosurgery in the treatment of mild to moderate AK lesions located on the head. To be able to quantify the effect the patient will be allocated to one of three treatments: PD P 506 A-PDT, cryosurgery or placebo-PDT.
Detailed description
Actinic keratosis (AK) is a pre-cancerous skin abnormality usually caused by sun exposure. Actinic keratoses occur most commonly in fair skin, especially in the elderly. They mainly occur in sun-exposed skin areas like head and hands. It is standard of care to remove AK when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (PDT). In Europe, cryosurgery is the method primarily used and will therefore serve as comparator therapy for PD P 506 A-PDT. A placebo control will be necessary to validate the test system. While the comparison of PD P 506 A-PDT and cryosurgery is an open comparison, placebo-PDT and PD P 506 A-PDT will be allocated in a double-blind manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- Caucasians
- Age > 18 years
- Diagnosis of actinic keratosis (AK) with at least four locally separated lesions located on head and/or face (hairless areas)
- Selected AK study lesions have clearly defined margins and are mild to moderate (grades I or II)
Key exclusion criteria (16 listed)
- PDT Non-responder
- Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding study treatment
- Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding study treatment with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
- Pre-treatment with hypericin during the 2 weeks preceding study therapy
- Treatment with systemic retinoids during the 3 months preceding study therapy
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 |
|---|---|---|
| Photodynamic Therapy | Procedure or surgery | – |
| Cryosurgery | Procedure or surgery | – |
Primary outcome
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment.
Time frame: 12 weeks
4 secondary outcomes
CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment
Time frame: 12 months
CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment
Time frame: 12 months
Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy (PDT or cryosurgery)
Time frame: 12 months
Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of no recurrence of the lesion
Time frame: 12 months
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 11 Apr 2008.
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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.
Rolf-Marcus Szeimies, Professor MD principal investigator
Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Photodynamic Therapy and Cryosurgery in people with Actinic Keratosis, run by photonamic GmbH & Co. KG at 26 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 8 inclusion and 16 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 11 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment. (time frame: 12 weeks). 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 11 Apr 2008.