Actinic KeratosesPhase 4NCT03963102
Duration of Ameluz Application in Acral Actinic Keratoses Response
A Phase 4 study testing Ameluz in people with Actinic Keratoses and Photodamaged Skin, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
Trial summary
A phase IV study of a single topical application of ALA for 3 hours or 4 hours to AK on acral sites (hands, feet, arms and legs), and subsequent measurement of clinical efficacy with corresponding PpIX fluorescence imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses, Photodamaged Skin
- What is being tested?
- Ameluz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2019to 31 Mar 2024
- Phase
- Phase 4
- 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
- Patient has given written informed consent.
- Males and females > 18 years.
- AK lesions on arms, hands, legs or feet that are practical to treat with PDT.
Who cannot join
- Lesions with a clinical diagnosis of Bowen's disease, superficial, morphoeic or nodular basal cell carcinoma, squamous cell carcinoma, or melanoma as they are not the types of lesions required for investigation.
- Any disease which is caused or exacerbated by light, including systemic lupus erythematosus, porphyria, actinic reticuloid or xeroderma pigmentosum. Part of the clinical study will be the use of light-imaging system so any condition, which is sensitive to such instruments, will be excluded.
- Males or females of childbearing potential, who are not practicing adequate contraceptive precaution. Female patients should practice strict birth control (oestrogen-containing oral contraceptives or an IUD) throughout the trial. Only post-menopausal women (12 months or more with no menses) and women who have had a hysterectomy are exempt from the requirements to use birth control. Male patients should also use adequate contraception for the duration of the trial.
- Pregnant or lactating females
- Treatment in the previous 45 days with any cryotherapy, topical treatments for AK, experimental compound, an iron chelating agent, radiotherapy, chemotherapy or with any light activated therapy or any other medication, which may render the patient light sensitive (e.g. PUVA).
- Photodynamic therapy treatment in the previous 90 days.
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- Co-existing ophthalmic disease likely to require slit lamp examination within 30 days of PDT treatment.
- Known allergies to porphyrins, peanut, soya or excipients.
- Patients not able to comply with study requirements.
- Patients on immunosuppression medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Investigate the Effect of Different Durations of Ameluz Application on Response to Treatment of Acral Actinic Keratoses
A phase IV study of a single topical application of ALA for 3 hours or 4 hours to AK on acral sites (hands, feet, arms and legs), and subsequent measurement of clinical efficacy with corresponding PpIX fluorescence imaging.
Read the detailed description
Photodynamic therapy (PDT) is a relatively new treatment for skin cancer and sun-damaged skin, which may turn cancerous or pre-cancerous. PDT treatment consists of applying a gel containing aminolevulinic acid hydrochloride (licensed for clinical use as Ameluz®) to the abnormal area. Inside the diseased cells this gel is changed over a few hours into a light-sensitive chemical (photosensitiser) that reacts with light. The photosensitiser is inactive by itself. A red light is then shone on to the lesion; this reacts with the photosensitiser and destroys the abnormal cells. Only the treated area will be affected and inflamed. The area will be cured in most cases after the inflammation clears.
Actinic keratosis (AK) is a type of pre-cancerous lesion caused by sun damage. If left, they can progress to become skin cancer. These can be treated in different ways, with different topical creams, liquid nitrogen or PDT. Some lesions may have reoccurred after topical creams, patients also have unacceptable amount of inflammation or the lesion involve too large an area. Liquid nitrogen is as good as PDT in treating AKs, however have been reported to leave a less good cosmetic result.
PDT is a licensed treatment for AK. However, PDT has been shown to be less effective for AKs on certain areas such as hands and feet. Further understanding of the build-up of the photosensitiser may enable better cure rates at these body parts, enabling more patients to benefit from PDT.
The proposed theory is that a longer application of the Ameluz gel will increase the amount of photosensitiser, which accumulates in the treated areas, and thus increase the amount of damage to cells, and mean that more patients have a successful treatment.
The aim of this study is to investigate whether applying the Ameluz gel for 4 hours (trial group) rather than 3 hours (control group) will improve treatment success rates in AK lesions on hands, feet, arms and legs. The information gained from this study may result in better treatment design of PDT for AK.
To do this the investigators plan to apply Ameluz® gel to AK lesions for either the standard 3 hours or the currently unlicensed 4 hours. The investigators will then measure the amount of that has changed into the photosensitiser, using a special digital camera. This camera device is not invasive and does not have any side effects. Some patients may have multiple AK lesions on multiple sites; the investigator aim to treat all these in the same manner due to practicality, and will record data for these lesions as well.
The investigator will record if patients report any associated pain during light delivery, as well as the temperature of the lesion during treatment. Some patients opt to have an external cooling system or water spray during the light treatment, but in order to standardise treatment during the trial this will not be used. The investigator will however give patients the option of taking paracetamol themselves prior to the treatment. A dermatology doctor will then review the patients at three months following treatment to see if their AK has been cured, and receive further treatment if needed.
The pathway is the same as standard PDT treatment and does not involve an extra visit.
- Conditions
- Actinic Keratoses, Photodamaged Skin
- Being tested
- Ameluz
- Keywords
- photodynamic therapy
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmeluzDrug
Leaving on the gel for 4 hours rather than the standard 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| Control Group 3 hours | Active comparator | Application of Ameluz for 3 hours. Receives: Drug: Ameluz |
| Trial Group 4 hours | Experimental | Application of Ameluz for 4 hours. Receives: Drug: Ameluz |
What is being measured
The primary outcome is the main question the study is designed to answer.
The odds of full clearance of individual lesions in the intervention and control groups will be compared (reported as an odds ratio with 95%CLs).
Clinical outcome at 3 months of the treated AK lesions on acral sites
Measured: 3 months
Secondary outcomes (5)
Clearance of lesions on other body sites
The odds of full clearance of any non-acral individual lesions in the intervention and control groups will be compared (reported as an odds ratio with 95%CLs). Lesions will be either cleared or not cleared.
Measured: 3 months
Pain Score
The mean of pain levels as measure by the Visual Analogue Scale with standard deviation will be provided between treatment arms.
Measured: 1 week
Photobleaching
Photobleaching will be calculated as the difference in fluorescence score before and after light treatment (change score). This is measured using the Dyaderm Fluroscence imaging system.
Measured: After data collection is completed, during analysis phase, expected at 12 months.
PpIX accumulation fluorescence
PpIX accumulation over time (3 measurements for each lesion) will be presented graphically, grouped by participant and lesion type (acral and non-acral). The accumulation score is the PpIX fluroscence measured before light treatment.
The fluorescence before light treatment will be compared between intervention and control groups with a random effects model. The analysis will be adjusted for baseline fluorescence, grade of lesion, and location of lesion. A change score analysis will be carried out for comparison.
Measured: After data collection is completed, during analysis phase, expected at 12 months.
PpIX dissipation fluorescence
PpIX dissipation over time (3 measurements for each lesion) will be presented graphically, grouped by participant and lesion type (acral and non-acral). The dissipation score is the PpIX fluroscence measured after light treatment.
The fluorescence after light treatment will be compared between intervention and control groups with a random effects model. The analysis will be adjusted for baseline fluorescence, grade of lesion, and location of lesion. A change score analysis will be carried out for comparison.
Measured: After data collection is completed, during analysis phase, expected at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start30 Oct 2019
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Why it stopped: Lack of appropriate personnel. Dr Xie abroad on other research, current PI Dr John Frewen not at main centre, no other available PI identified. Study suspended.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control study, prospective, assessor blinded.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963102
- Sponsor's protocol ID
- PDT AK v1
- Status last verified
- Jul 2024
- First submitted
- 19 Mar 2019
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Please contact study coordinators to see if non-patient identifiable information can be release.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effect of Different Durations of Ameluz Application on Response to Treatment of Acral Actinic Keratoses
- ClinicalTrials.gov ID
- NCT03963102
- Acronym / sponsor ID
- PDT AK v1
- Conditions
- Actinic Keratoses, Photodamaged Skin
- Keywords
- photodynamic therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of appropriate personnel. Dr Xie abroad on other research, current PI Dr John Frewen not at main centre, no other available PI identified. Study suspended.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 24 May 2019 (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.
A phase IV study of a single topical application of ALA for 3 hours or 4 hours to AK on acral sites (hands, feet, arms and legs), and subsequent measurement of clinical efficacy with corresponding PpIX fluorescence imaging.
Detailed description
Photodynamic therapy (PDT) is a relatively new treatment for skin cancer and sun-damaged skin, which may turn cancerous or pre-cancerous. PDT treatment consists of applying a gel containing aminolevulinic acid hydrochloride (licensed for clinical use as Ameluz®) to the abnormal area. Inside the diseased cells this gel is changed over a few hours into a light-sensitive chemical (photosensitiser) that reacts with light. The photosensitiser is inactive by itself. A red light is then shone on to the lesion; this reacts with the photosensitiser and destroys the abnormal cells. Only the treated area will be affected and inflamed. The area will be cured in most cases after the inflammation clears.
Actinic keratosis (AK) is a type of pre-cancerous lesion caused by sun damage. If left, they can progress to become skin cancer. These can be treated in different ways, with different topical creams, liquid nitrogen or PDT. Some lesions may have reoccurred after topical creams, patients also have unacceptable amount of inflammation or the lesion involve too large an area. Liquid nitrogen is as good as PDT in treating AKs, however have been reported to leave a less good cosmetic result.
PDT is a licensed treatment for AK. However, PDT has been shown to be less effective for AKs on certain areas such as hands and feet. Further understanding of the build-up of the photosensitiser may enable better cure rates at these body parts, enabling more patients to benefit from PDT.
The proposed theory is that a longer application of the Ameluz gel will increase the amount of photosensitiser, which accumulates in the treated areas, and thus increase the amount of damage to cells, and mean that more patients have a successful treatment.
The aim of this study is to investigate whether applying the Ameluz gel for 4 hours (trial group) rather than 3 hours (control group) will improve treatment success rates in AK lesions on hands, feet, arms and legs. The information gained from this study may result in better treatment design of PDT for AK.
To do this the investigators plan to apply Ameluz® gel to AK lesions for either the standard 3 hours or the currently unlicensed 4 hours. The investigators will then measure the amount of that has changed into the photosensitiser, using a special digital camera. This camera device is not invasive and does not have any side effects. Some patients may have multiple AK lesions on multiple sites; the investigator aim to treat all these in the same manner due to practicality, and will record data for these lesions as well.
The investigator will record if patients report any associated pain during light delivery, as well as the temperature of the lesion during treatment. Some patients opt to have an external cooling system or water spray during the light treatment, but in order to standardise treatment during the trial this will not be used. The investigator will however give patients the option of taking paracetamol themselves prior to the treatment. A dermatology doctor will then review the patients at three months following treatment to see if their AK has been cured, and receive further treatment if needed.
The pathway is the same as standard PDT treatment and does not involve an extra visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised control study, prospective, assessor blinded.
| Arm | Type | Receives |
|---|---|---|
| Control Group 3 hours | Active comparator | Drug: AmeluzApplication of Ameluz for 3 hours. |
| Trial Group 4 hours | Experimental | Drug: AmeluzApplication of Ameluz for 4 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has given written informed consent.
- Males and females > 18 years.
- AK lesions on arms, hands, legs or feet that are practical to treat with PDT.
Key exclusion criteria (10 listed)
- Lesions with a clinical diagnosis of Bowen's disease, superficial, morphoeic or nodular basal cell carcinoma, squamous cell carcinoma, or melanoma as they are not the types of lesions required for investigation.
- Any disease which is caused or exacerbated by light, including systemic lupus erythematosus, porphyria, actinic reticuloid or xeroderma pigmentosum. Part of the clinical study will be the use of light-imaging system so any condition, which is sensitive to such instruments, will be excluded.
- Males or females of childbearing potential, who are not practicing adequate contraceptive precaution. Female patients should practice strict birth control (oestrogen-containing oral contraceptives or an IUD) throughout the trial. Only post-menopausal women (12 months or more with no menses) and women who have had a hysterectomy are exempt from the requirements to use birth control. Male patients should also use adequate contraception for the duration of the trial.
- Pregnant or lactating females
- Treatment in the previous 45 days with any cryotherapy, topical treatments for AK, experimental compound, an iron chelating agent, radiotherapy, chemotherapy or with any light activated therapy or any other medication, which may render the patient light sensitive (e.g. PUVA).
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 |
|---|---|---|
| AmeluzLeaving on the gel for 4 hours rather than the standard 3 hours. | Drug | Control Group 3 hours, Trial Group 4 hours |
Primary outcome
The odds of full clearance of individual lesions in the intervention and control groups will be compared (reported as an odds ratio with 95%CLs).
Time frame: 3 months
Clinical outcome at 3 months of the treated AK lesions on acral sites
5 secondary outcomes
Clearance of lesions on other body sites
Time frame: 3 months
Pain Score
Time frame: 1 week
Photobleaching
Time frame: After data collection is completed, during analysis phase, expected at 12 months.
PpIX accumulation fluorescence
Time frame: After data collection is completed, during analysis phase, expected at 12 months.
PpIX dissipation fluorescence
Time frame: After data collection is completed, during analysis phase, expected at 12 months.
Results and safety
The study was stopped early (reason given: Lack of appropriate personnel. Dr Xie abroad on other research, current PI Dr John Frewen not at main centre, no other available PI identified. Study suspended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No. Please contact study coordinators to see if non-patient identifiable information can be release.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ameluz in people with Actinic Keratoses and Photodamaged Skin, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Jul 2024. 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Lack of appropriate personnel. Dr Xie abroad on other research, current PI Dr John Frewen not at main centre, no other available PI identified. Study suspended.). Results are not available in the source record.
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 odds of full clearance of individual lesions in the intervention and control groups will be compared (reported as an odds ratio with 95%CLs). (time frame: 3 months). 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 26 Jul 2024.