Actinic KeratosisPDTNCT02878382
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
A study testing Conventional MAL-PDT and Calcipotriol assisted MAL-PDT in people with Actinic Keratosis, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL), is converted to the endogenous photosensitizer protoporphyrinIX (PpIX). Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Conventional MAL-PDT and Calcipotriol assisted MAL-PDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2016to Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male gender
- at least six AKs per field
Who cannot join
- history of photosensitivity related disorders
- active infectious disease,
- immunosuppression
- laser or any cosmetic treatment in the previous 6 months
- other topical agents in the treatment area such as retinoids, 5-fluorouracil,imiquimod or diclofenac sodium in the previous 3 months
- allergy to MAL or excipients of the cream
- poor patient compliance.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Universidade de Sao Paulo
São Paulo, São Paulo, 04543120
Hospital Das Clinicas Universidade Sao Paulo
São Paulo, São Paulo
About this study
Official title: Efficacy of Calcipotriol Assisted MAL-PDT Versus Conventional MAL-PDT for Actinic Keratosis: a Randomized and Controlled Study
In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL), is converted to the endogenous photosensitizer protoporphyrinIX (PpIX).
Reduced response rates are observed in thicker skin lesions, which may be due to insufficient PpIX accumulation within the target tissue.
Read more
To enhance PpIX production,several physical and chemical pretreatments have been suggested. One of the chemical substances proposed to stimulate PpIX production is vitamin D because of its ability of being a keratinocyte pro-differentiating hormone.
Based on in vitro and in animal model studies, we propose to study the potential impact of patient vitamin D pre-treatment in AK response to MAL-PDT.
Read the detailed description
A randomized, controlled Split -scalp study with Calcipotriol Assisted MAL-PDT versus conventional MAL-PDT for actinic keratosis (AK) is proposed.
Twenty patients ( male gender only) with symmetrically distributed multiple AK lesions on the scalp will be included. Patients must have at least five AKs per field to be eligible.
After simple randomization, one half of the scalp will be treated with Calcipotriol ointment 50 mcg/g (Daivonex, Leo Pharma, Denmark) for 15 consecutive days.
After this period, the entire scalp will be submitted to topical PDT with Methylaminolevulinate 16% (Metvix, Galderma France) under occlusion for 90 minutes and then, illuminated with a light source consisting of a Light Emitting Diode device (LED) at 635 nm ( Aktilite - Photocure, Norway). The total light dose will be 37J/cm2.
Immediately before and after illumination with LED, measurements of the fluorescence intensity will be taken in 3 isolated spots in both sides of the scalp with a spectroscopy deviceUSB 2000+ ( Ocean Optics ® - Dunedin, Fl, USA).
AK lesions will be counted and mapped by a dermatologist not involved in the study before and after 3 months.
All patients will be advised to apply sunscreens 50 + 3x/day for the following 7 days after the procedure.
A 0-10 Visual Analogue Scale (VAS) will be used to measure the pain intensity during the illumination.
Records will be taken after 90 days and compared between sides: side effects, AK lesion response and pain level intensity. Also, a long term follow up will be provided at 6 and 12 months after.
- Conditions
- Actinic Keratosis
- Being tested
- Conventional MAL-PDT, Calcipotriol assisted MAL-PDT
- Keywords
- PDT, skin cancer, calcipotriol
- Medical subject headings
- Keratosis, Actinic, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional MAL-PDTOther
Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose
Calcipotriol assisted MAL-PDTOther
Calcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose
| Study group | Role | What they receive |
|---|---|---|
| Conventional MAL-PDT | Other | Conventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs. Receives: Other: Conventional MAL-PDT |
| Calcipotriol assisted MAL-PDT | Other | Calcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT Receives: Other: Calcipotriol assisted MAL-PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes From Baseline in Actinic Keratosis - Lesion Base Count.
To compare the efficacy of topical PDT alone versus Calcipotriol assisted PDT for AKs on the scalp.
The values in the data table represent the mean (+sd) number of lesions on each side at 3, 6 and 12 months post intervention.
Lesion counts include lesions that have not been cleared and also newly emerged lesions ( if new lesions emerge on the treated field) At baseline: number of AKs was 290 on the CAL-PDT side and 284 on the conventional side.
Measured: Change from baseline, 90 days, 180 days and 12 months after the PDT
Percentage of Actinic Keratosis (AK) Lesions Cleared
AK clearance after PDT and comparison between the sides The values in the data table represent the percentage of AK clearance on each side at 3, 6 and 12 months post intervention.
At baseline: 290 on the CAL-PDT side and 284 on the conventional side.
Measured: Change from baseline, 90 days, 6 months and 12 months after PDT
Secondary outcomes (2)
Pain Scores Immediately Post Illumination
Measurement of pain during LED illumination and comparison between the sides with a visual analogue scale (VAS), considering 0 as absence of pain and 10 as the most severe pain.
At baseline, before the illumination, there is an absence of pain, which means Score 0 (zero) for all participants before the procedure.
Pain is reffered during and after the illumination and measured with the VAS scale, reported by each patient.
Measured: immediately after intervention
Change From Baseline in Fluorescence Intensity of PPIX
Measurement of PPIX fluorescence on both sides of the scalp before and immediately after LED illumination PpIX fluorescence was measured in three different spot areas on the scalp before and immediately after PDT on each side.
The measurements were taken noninvasively in the areas where PpIX fluorescence was more intense, with a handheld fluorescence photometer (USB 2000+ spectroscopy device; Ocean Optics, Dunedin, FL, U.S.A.). The photometer illuminates a circular skin area with a diameter of 1 cm with blue light (400-420 nm), matching the Soret band of PpIX at 405-420 nm. By measuring excitation wavelengths at 600- 700 nm, the corresponding red PpIX fluorescence intensity at 633 nm is detected. Measurements were taken in arbitrary units. The mean PpIX fluorescence value for each side was calculated before and after the treatment.
Measured: Baseline and 10 minutes after illumination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Antonio Torezan, University of Sao Paulo
- Investigators
- Luis A Torezan, MD, Principal investigator, Hospital das Clinicas FMUSP Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878382
- Sponsor's protocol ID
- 08/2016
- Acronym
- PDT
- Status last verified
- Jul 2020
- First submitted
- 10 Aug 2016
- Last updated
- 4 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Calcipotriol Assisted MAL-PDT Versus Conventional MAL-PDT for Actinic Keratosis: a Randomized and Controlled Study
- ClinicalTrials.gov ID
- NCT02878382
- Acronym / sponsor ID
- PDT / 08/2016
- Conditions
- Actinic Keratosis
- Keywords
- PDT, skin cancer, calcipotriol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Posted 4 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL), is converted to the endogenous photosensitizer protoporphyrinIX (PpIX).
Reduced response rates are observed in thicker skin lesions, which may be due to insufficient PpIX accumulation within the target tissue.
To enhance PpIX production,several physical and chemical pretreatments have been suggested. One of the chemical substances proposed to stimulate PpIX production is vitamin D because of its ability of being a keratinocyte pro-differentiating hormone.
Based on in vitro and in animal model studies, we propose to study the potential impact of patient vitamin D pre-treatment in AK response to MAL-PDT.
Detailed description
A randomized, controlled Split -scalp study with Calcipotriol Assisted MAL-PDT versus conventional MAL-PDT for actinic keratosis (AK) is proposed.
Twenty patients ( male gender only) with symmetrically distributed multiple AK lesions on the scalp will be included. Patients must have at least five AKs per field to be eligible.
After simple randomization, one half of the scalp will be treated with Calcipotriol ointment 50 mcg/g (Daivonex, Leo Pharma, Denmark) for 15 consecutive days.
After this period, the entire scalp will be submitted to topical PDT with Methylaminolevulinate 16% (Metvix, Galderma France) under occlusion for 90 minutes and then, illuminated with a light source consisting of a Light Emitting Diode device (LED) at 635 nm ( Aktilite - Photocure, Norway). The total light dose will be 37J/cm2.
Immediately before and after illumination with LED, measurements of the fluorescence intensity will be taken in 3 isolated spots in both sides of the scalp with a spectroscopy deviceUSB 2000+ ( Ocean Optics ® - Dunedin, Fl, USA).
AK lesions will be counted and mapped by a dermatologist not involved in the study before and after 3 months.
All patients will be advised to apply sunscreens 50 + 3x/day for the following 7 days after the procedure.
A 0-10 Visual Analogue Scale (VAS) will be used to measure the pain intensity during the illumination.
Records will be taken after 90 days and compared between sides: side effects, AK lesion response and pain level intensity. Also, a long term follow up will be provided at 6 and 12 months after.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional MAL-PDT | Other | Other: Conventional MAL-PDTConventional topical PDT with Methylaminolevulinate 16% in one half of the scalp with multiple AKs. |
| Calcipotriol assisted MAL-PDT | Other | Other: Calcipotriol assisted MAL-PDTCalcipotriol ointment 50 mcg/g applied once a day for 15 consecutive days in one half of the scalp, before Conventional topical PDT |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male gender
- at least six AKs per field
Key exclusion criteria (7 listed)
- history of photosensitivity related disorders
- active infectious disease,
- immunosuppression
- laser or any cosmetic treatment in the previous 6 months
- other topical agents in the treatment area such as retinoids, 5-fluorouracil,imiquimod or diclofenac sodium in the previous 3 months
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 |
|---|---|---|
| Conventional MAL-PDTCurettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose | Other | Conventional MAL-PDT |
| Calcipotriol assisted MAL-PDTCalcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose | Other | Calcipotriol assisted MAL-PDT |
Primary outcome
Changes From Baseline in Actinic Keratosis - Lesion Base Count.
Time frame: Change from baseline, 90 days, 180 days and 12 months after the PDT
To compare the efficacy of topical PDT alone versus Calcipotriol assisted PDT for AKs on the scalp. The values in the data table represent the mean (+sd) number of lesions on each side at 3, 6 and 12 months post intervention. Lesion counts include lesions that have not been cleared and also newly emerged lesions ( if new lesions emerge on the treated field) At baseline: number of AKs was 290 on the CAL-PDT side and 284 on the conventional side.
Percentage of Actinic Keratosis (AK) Lesions Cleared
Time frame: Change from baseline, 90 days, 6 months and 12 months after PDT
AK clearance after PDT and comparison between the sides The values in the data table represent the percentage of AK clearance on each side at 3, 6 and 12 months post intervention. At baseline: 290 on the CAL-PDT side and 284 on the conventional side.
2 secondary outcomes
Pain Scores Immediately Post Illumination
Time frame: immediately after intervention
Change From Baseline in Fluorescence Intensity of PPIX
Time frame: Baseline and 10 minutes after illumination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Luis A Torezan, MD principal investigator
Hospital das Clinicas FMUSP Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional MAL-PDT and Calcipotriol assisted MAL-PDT in people with Actinic Keratosis, run by University of Sao Paulo at 2 sites in Brazil.
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 7 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 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Yes. Results are posted in the registry (first posted 4 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes From Baseline in Actinic Keratosis - Lesion Base Count. (time frame: Change from baseline, 90 days, 180 days and 12 months after the PDT). The study lists 2 primary outcomes in all. 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 4 Aug 2020.