Actinic KeratosisNCT03013647
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization
A study testing Methyl Aminolevulinate in people with Actinic Keratosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and will be treated with Daylight Photodynamic therapy. Before and after skin biopsies will be performed, for histological and immunohistochemical analysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Methyl Aminolevulinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2016to Jul 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -multiple (at least five) actinic keratosis on the face, grades I and II
Who cannot join
- phototypes IV, V and VI
- patients treated for actinic keratosis up to 6 months before
- history of allergy to methyl aminolevulinate
- history of photoallergy
- pregnancy
Trial locations and contacts
1 site in 1 country.
Luis Torezan, md contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas
São Paulo, São Paulo
Beni Grinblat, md, 551138827070, bgrinblat@gmail.com
Luis torezan, md, torezanluis@uol.com.br
About this study
Official title: Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis
Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and will be treated with Daylight Photodynamic therapy.
Before and after skin biopsies will be performed, for histological and immunohistochemical analysis.
Read the detailed description
Twenty patients with multiple thin actinic keratosis (AK) on the face will be included in the study. They will be informed of the procedure in detail and sign a consent form.
Digital photographs will be done in a standardized way. Prior to treatment, all patients will undergo 2 skin biopsies under local anesthesia and with a 2 mm punch biopsy. One biopsy will be done over an AK lesion and the other in an area with no apparent AK (field cancerization).
The patients will be treated with Daylight Photodynamic Therapy, following these steps:
- mild curettage of the AK lesions
- application of a chemical sunscreen with sun protection factor (SPF) 30
- application of methyl Aminolevulinate cream (Metvix R, Galderma Laboratories)
- exposition to daylight, for 120 minutes
- cleaning of the face
Three months after treatment, two new skin biopsies will be collected, 1cm away from the initial biopsies. On the same date, new photographs will be made following the same standards as pre-treatment photographs.
- Conditions
- Actinic Keratosis
- Being tested
- Methyl Aminolevulinate
- Keywords
- actinic keratosis, field cancerization, photodynamic therapy, daylight 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.
Methyl AminolevulinateDrug
Also called Metvix
Patients will be treated with Daylight Photodynamic therapy, following these steps:
- mild curettage of the AK lesions
- application of a chemical sunscreen SPF 30
- application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories)
- exposition to daylight, for 120 minutes
- cleaning of the face
| Study group | Role | What they receive |
|---|---|---|
| Actinic Keratosis | Other | Twenty patients with multiple thin AK on the face will be treated with Daylight Photodynamic Therapy with methyl aminolevulinate Skin biopsies before and after treatment will be performed in an AK lesion and in a field cancerization area. Receives: Drug: Methyl Aminolevulinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Counting of Actinic keratosis
Measured: 3 months after treatment
Secondary outcomes (2)
Histological changes
Histopathologic analysis in skin biopsies
Measured: 3 months after treatment
immunochemistry changes
immunochemistry analysis in skin biopsies
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionApr 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BENI MOREINAS GRINBLAT, University of Sao Paulo General Hospital
- Investigators
- Cyro Festa, md, Study chair, Hospital das Clinicas da USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013647
- Sponsor's protocol ID
- 1.788.362
- Status last verified
- Jan 2017
- First submitted
- 28 Nov 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Fargnoli MC, Piccioni A, Neri L, Tambone S, Pellegrini C, Peris K. Long-term efficacy and safety of daylight photodynamic therapy with methyl amninolevulinate for actinic keratosis of the face and scalp. Eur J Dermatol. 2017 Feb 1;27(1):89-91. doi: 10.1684/ejd.2016.2882. No abstract available.
PubMed 27748261Grinblat B, Galimberti G, Pantoja G, Sanclemente G, Lopez M, Alcala D, Torezan L, Kerob D, Pascual T, Chouela E. Feasibility of daylight-mediated photodynamic therapy for actinic keratosis throughout the year in Central and South America: a meteorological study. Int J Dermatol. 2016 Sep;55(9):e488-93. doi: 10.1111/ijd.13256. Epub 2016 Apr 7.
PubMed 27061814Philipp-Dormston WG, Sanclemente G, Torezan L, Tretti Clementoni M, Le Pillouer-Prost A, Cartier H, Szeimies RM, Bjerring P. Daylight photodynamic therapy with MAL cream for large-scale photodamaged skin based on the concept of 'actinic field damage': recommendations of an international expert group. J Eur Acad Dermatol Venereol. 2016 Jan;30(1):8-15. doi: 10.1111/jdv.13327. Epub 2015 Nov 9.
PubMed 26552049Grinblat B, Galimberti G, Chouela E, Sanclemente G, Lopez M, Alcala D, Torezan L, Pantoja G. Daylight-mediated photodynamic therapy for actinic damage in Latin America: consensus recommendations. Photodermatol Photoimmunol Photomed. 2016 Mar;32(2):81-7. doi: 10.1111/phpp.12221. Epub 2015 Dec 9.
PubMed 26541910
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis
- ClinicalTrials.gov ID
- NCT03013647
- Acronym / sponsor ID
- 1.788.362
- Conditions
- Actinic Keratosis
- Keywords
- actinic keratosis, field cancerization, photodynamic therapy, daylight photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 6 Jan 2017 (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.
Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and will be treated with Daylight Photodynamic therapy.
Before and after skin biopsies will be performed, for histological and immunohistochemical analysis.
Detailed description
Twenty patients with multiple thin actinic keratosis (AK) on the face will be included in the study. They will be informed of the procedure in detail and sign a consent form.
Digital photographs will be done in a standardized way. Prior to treatment, all patients will undergo 2 skin biopsies under local anesthesia and with a 2 mm punch biopsy. One biopsy will be done over an AK lesion and the other in an area with no apparent AK (field cancerization).
The patients will be treated with Daylight Photodynamic Therapy, following these steps:
- mild curettage of the AK lesions
- application of a chemical sunscreen with sun protection factor (SPF) 30
- application of methyl Aminolevulinate cream (Metvix R, Galderma Laboratories)
- exposition to daylight, for 120 minutes
- cleaning of the face
Three months after treatment, two new skin biopsies will be collected, 1cm away from the initial biopsies. On the same date, new photographs will be made following the same standards as pre-treatment photographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actinic Keratosis | Other | Drug: Methyl AminolevulinateTwenty patients with multiple thin AK on the face will be treated with Daylight Photodynamic Therapy with methyl aminolevulinate Skin biopsies before and after treatment will be performed in an AK lesion and in a field cancerization area. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -multiple (at least five) actinic keratosis on the face, grades I and II
Key exclusion criteria (5 listed)
- phototypes IV, V and VI
- patients treated for actinic keratosis up to 6 months before
- history of allergy to methyl aminolevulinate
- history of photoallergy
- pregnancy
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 |
|---|---|---|
| Methyl AminolevulinateAlso: MetvixPatients will be treated with Daylight Photodynamic therapy, following these steps: 1. mild curettage of the AK lesions 2. application of a chemical sunscreen SPF 30 3. application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories) 4. exposition to daylight, for 120 minutes 5. cleaning of the face | Drug | Actinic Keratosis |
Primary outcome
Clinical improvement
Time frame: 3 months after treatment
Counting of Actinic keratosis
2 secondary outcomes
Histological changes
Time frame: 3 months after treatment
immunochemistry changes
Time frame: 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Background: PubMed 27748261Fargnoli MC, Piccioni A, Neri L, Tambone S, Pellegrini C, Peris K. Long-term efficacy and safety of daylight photodynamic therapy with methyl amninolevulinate for actinic keratosis of the face and scalp. Eur J Dermatol. 2017 Feb 1;27(1):89-91. doi: 10.1684/ejd.2016.2882. No abstract available.
- Background: PubMed 27061814Grinblat B, Galimberti G, Pantoja G, Sanclemente G, Lopez M, Alcala D, Torezan L, Kerob D, Pascual T, Chouela E. Feasibility of daylight-mediated photodynamic therapy for actinic keratosis throughout the year in Central and South America: a meteorological study. Int J Dermatol. 2016 Sep;55(9):e488-93. doi: 10.1111/ijd.13256. Epub 2016 Apr 7.
- Background: PubMed 26552049Philipp-Dormston WG, Sanclemente G, Torezan L, Tretti Clementoni M, Le Pillouer-Prost A, Cartier H, Szeimies RM, Bjerring P. Daylight photodynamic therapy with MAL cream for large-scale photodamaged skin based on the concept of 'actinic field damage': recommendations of an international expert group. J Eur Acad Dermatol Venereol. 2016 Jan;30(1):8-15. doi: 10.1111/jdv.13327. Epub 2015 Nov 9.
- Background: PubMed 26541910Grinblat B, Galimberti G, Chouela E, Sanclemente G, Lopez M, Alcala D, Torezan L, Pantoja G. Daylight-mediated photodynamic therapy for actinic damage in Latin America: consensus recommendations. Photodermatol Photoimmunol Photomed. 2016 Mar;32(2):81-7. doi: 10.1111/phpp.12221. Epub 2015 Dec 9.
- 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 Torezan, md contact
Cyro Festa, md study chair
Hospital das Clinicas da USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methyl Aminolevulinate in people with Actinic Keratosis, run by University of Sao Paulo General Hospital at 1 site 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beni Grinblat, md (551138827070, bgrinblat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03013647, which also lists 4 linked publications.
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 6 Jan 2017.