Actinic KeratosesPhase 2NCT03606122
5-ALA Patch-PDT of Actinic Keratosis on the Upper Extremities
A Phase 2 study testing PD P 506 A in people with Actinic Keratoses, run by photonamic GmbH & Co. KG at 1 site in Germany.
Trial summary
This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with actinic keratosis on the upper extremities for the first time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- PD P 506 A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 12 Jul 2018to 16 Jul 2019
- Phase
- Phase 2
- 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 has been signed prior to or at Screening Visit
- Caucasian male and female patients
- Age ≥ 18 years
- Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on the upper extremities
- Selected AK study lesions have clearly defined margins and are mild to severe (grades I to III):
- Mild grade (I): Slight palpability, better felt than seen
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- Moderate grade (II): Moderately thick AK, easily felt
- Severe grade (III): Very thick and/or obvious AK
- 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 PDT (e.g. antineoplastic topical formulations as e.g. Metvix®, Ameluz®, Luxerm®, Solaraze®, Aldara®, Picato®, Actikerall®, 5-FU or vitamin A acid containing formulations)
- Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding PDT with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
- Pre-treatment with hypericin during the 2 weeks preceding PDT
- Treatment with systemic retinoids during the 3 months preceding PDT
- Treatment with cytostatics or radiation during the 3 months preceding PDT
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- Female patients of childbearing potential (A female is considered of childbearing potential unless she has had tubal ligation, hysterectomy or has been postmenopausal, i.e. with spontaneous amenorrhea for at least 12 months.)
- Patients with clinically relevant suppression of the immune system
- Diagnosis of Porphyria
- Known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematosus or pemphigus erythematosus
- Concomitant use of medicinal products with known phototoxic or photoallergic potential such as hypericin, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines
- Skin diseases that might interfere with response evaluation of study PDT
- Skin sun sensitivity type V or VI according to Fitzpatrick
- Known intolerance to one or more of the ingredients of the study medication
- 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
1 site in 1 country.
About this study
Official title: Evaluation of the Suitability of a 5-ALA Patch (PD P 506 A, Alacare®) in the Photodynamic Therapy (PDT) of Actinic Keratosis on the Upper Extremities
This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with actinic keratosis on the upper extremities for the first time.
Read the detailed description
Patients will receive a second PD P 506 A-PDT on all AK lesions 1-2 weeks after the first PDT.
- Conditions
- Actinic Keratoses
- Being tested
- PD P 506 A
- Keywords
- Actinic keratosis on the upper extremities
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD P 506 ADrug
Also called Alacare®
PD P 506 A is a dermal patch of 4 cm² in size loaded with 2 mg 5-ALA (as 5-ALA HCl) per cm²
| Study group | Role | What they receive |
|---|---|---|
| PD P 506 A-PDT | Experimental | The study medication will be applied to each study lesion for 4 hours. After removal of the study medication the study lesions will be illuminated with red light of defined wavelength (PDT). Second PDT of the lesions will be performed 6-14 days after the first PDT. Receives: Drug: PD P 506 A |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of the study is the evaluation of the clinical activity of PD P 506 A-PDT of AK on the upper extremities on lesion basis 12 weeks after treatment.
Percentage of lesions with Clinically Complete Clearance (CCR) 12 weeks after two study treatments.
Measured: 12 weeks after treatment.
Secondary outcomes (2)
Number and severity of treatment-related adverse events as assessed by NIA Adverse Event and Serious Adverse Event Guidelines.
The secondary aim of the study is the evaluation of safety and tolerability of PD P 506 A-PDT of AK on the upper extremities.
Measured: 12 weeks after treatment.
In addition, the percentage of lesions with at least partial clearance 12 weeks after last study treatment will be analysed as a secondary parameter
Percentage of lesions with at least partial clearance 12 weeks after two study treatments.
Measured: 12 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start12 Jul 2018
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- photonamic GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uwe Reinhold, Professor, Principal investigator, Dermatologisches Zentrum Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606122
- Sponsor's protocol ID
- AK 13
- Status last verified
- Dec 2018
- First submitted
- 11 Jul 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Suitability of a 5-ALA Patch (PD P 506 A, Alacare®) in the Photodynamic Therapy (PDT) of Actinic Keratosis on the Upper Extremities
- ClinicalTrials.gov ID
- NCT03606122
- Acronym / sponsor ID
- AK 13
- Conditions
- Actinic Keratoses
- Keywords
- Actinic keratosis on the upper extremities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- photonamic GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 30 Jul 2018 (actual)
- 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 evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with actinic keratosis on the upper extremities for the first time.
Detailed description
Patients will receive a second PD P 506 A-PDT on all AK lesions 1-2 weeks after the first PDT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD P 506 A-PDT | Experimental | Drug: PD P 506 AThe study medication will be applied to each study lesion for 4 hours. After removal of the study medication the study lesions will be illuminated with red light of defined wavelength (PDT). Second PDT of the lesions will be performed 6-14 days after the first PDT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent has been signed prior to or at Screening Visit
- Caucasian male and female patients
- Age ≥ 18 years
- Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on the upper extremities
- Selected AK study lesions have clearly defined margins and are mild to severe (grades I to III):
Key exclusion criteria (17 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 PDT (e.g. antineoplastic topical formulations as e.g. Metvix®, Ameluz®, Luxerm®, Solaraze®, Aldara®, Picato®, Actikerall®, 5-FU or vitamin A acid containing formulations)
- Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding PDT with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
- Pre-treatment with hypericin during the 2 weeks preceding PDT
- Treatment with systemic retinoids during the 3 months preceding PDT
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 |
|---|---|---|
| PD P 506 AAlso: Alacare®PD P 506 A is a dermal patch of 4 cm² in size loaded with 2 mg 5-ALA (as 5-ALA HCl) per cm² | Drug | PD P 506 A-PDT |
Primary outcome
The primary aim of the study is the evaluation of the clinical activity of PD P 506 A-PDT of AK on the upper extremities on lesion basis 12 weeks after treatment.
Time frame: 12 weeks after treatment.
Percentage of lesions with Clinically Complete Clearance (CCR) 12 weeks after two study treatments.
2 secondary outcomes
Number and severity of treatment-related adverse events as assessed by NIA Adverse Event and Serious Adverse Event Guidelines.
Time frame: 12 weeks after treatment.
In addition, the percentage of lesions with at least partial clearance 12 weeks after last study treatment will be analysed as a secondary parameter
Time frame: 12 weeks after treatment.
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 28 Aug 2019.
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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.
Uwe Reinhold, Professor principal investigator
Dermatologisches Zentrum Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD P 506 A in people with Actinic Keratoses, run by photonamic GmbH & Co. KG at 1 site 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 9 inclusion and 17 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary aim of the study is the evaluation of the clinical activity of PD P 506 A-PDT of AK on the upper extremities on lesion basis 12 weeks after treatment. (time frame: 12 weeks after treatment.). 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 28 Aug 2019.