Actinic KeratosesNCT06545396
Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic Keratoses
A study testing Half-dose illumination protocol and Full-dose illumination protocol in people with Actinic Keratoses, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal.
Trial summary
The goal of this clinical trial is to compare the tolerance and efficacy of conventional photodynamic therapy (PDT) with red light versus PDT with red light at half dose of illumination, as well as the changes produced by both interventions at the biomolecular level in patients with multiple actinic keratosis on the… 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?
- Half-dose illumination protocol and Full-dose illumination protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with grade I and II actinic keratoses (AK) of Olsen on the scalp requiring field cancerization treatment.
- ≥ 18 years old.
- More than 5 AK per field of cancerization to be treated.
- More than 6 months since the last field treatment for AK performed.
- No AK in clinical grade III progression of Olsen or showing signs suggestive of being invasive squamous cell carcinoma.
Who cannot join
- Patients with photodermatoses.
- Patients sensitive to methyl-aminolevulinate.
- Patients with disabilities or unable to provide informed consent.
- Patients who do not tolerate or do not wish to be treated with PDT.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Characterization Of The Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For The Treatment Of Actinic Keratoses And Their Cancerization Field
The goal of this clinical trial is to compare the tolerance and efficacy of conventional photodynamic therapy (PDT) with red light versus PDT with red light at half dose of illumination, as well as the changes produced by both interventions at the biomolecular level in patients with multiple actinic keratosis on the scalp. The main questions it aims to answer are:
Does PDT with half-dose illumination protocol maintain clinical and biomolecular efficacy?
Read more
Does PDT with half-dose illumination protocol improve intervention tolerance?
Researchers will compare both treatment protocols using the patient as its own control.
Participants scalp will be divided in two halves, one will be treated with PDT at conventional doses and the other with the half-dose illumination protocol, a skin biopsy will be obtained both pre and post-treatment of each of the areas. Variables will be assessed during the 3 visits of the study.
Read the detailed description
The goal of the clinical trial is to compare efficacy and tolerance of photodynamic therapy (PDT) with red light at half dose illumination protocol with conventional PDT for the treatment of grade I and II actinic keratosis. The main hypotheses is that half-light protocol PDT could maintain efficacy while improving tolerance of the procedure.
With this aim the investigators will compare the efficacy of the clinical response after field treatment with photodynamic therapy with red light at half dose versus conventional photodynamic therapy with standard red light in patients with scalp actinic keratoses as well as determine changes in molecular biomarkers at the histological and immunohistochemical level pre- and post-treatment with conventional PDT and PDT with red light at half dose.
The included patients will have their scalp divided into two halves of similar size using the interparietal line as a separation method; one half will be treated with conventional PDT and the other half with half-dose PDT. This is a comparative study between two treatment modalities, both of which will be applied to all patients, and in half of the sample, four skin biopsies of the affected area (two pre and tw post-treatment) will also be performed to conduct an immunohistochemical analysis of the skin samples. Both treatment protocols will be compared using the patient as his or her own protocol. Variables will be assessed during the 3 visits of the study (baseline, 3 months and 6 months).
- Conditions
- Actinic Keratoses
- Being tested
- Half-dose illumination protocol, Full-dose illumination protocol
- 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.
Half-dose illumination protocolOther
Area will be treated according to the classic protocol, in a single session. First, the surface of the actinic keratoses will be scraped to remove scales and crusts. Using a spatula, a sufficient amount of photosensitizing cream will be applied to cover the treatment area (1 mm thick). The treated area will then be covered with an occlusive dressing for 3 hours. After this interval, the dressing will be removed and the area will be exposed to a red light source for 8 minutes with a spectrum of 630 nm and 18,5J/cm2, with the illumination intensity being less than 200 mW/cm2.
Full-dose illumination protocolOther
Area will be treated according to the classic protocol, in a single session. First, the surface of the actinic keratoses will be scraped to remove scales and crusts. Using a spatula, a sufficient amount of photosensitizing cream will be applied to cover the treatment area (1 mm thick). The treated area will then be covered with an occlusive dressing for 3 hours. After this interval, the dressing will be removed and the area will be exposed to a red light source for 8 minutes with a spectrum of 630 nm and 37J/cm2, with the illumination intensity being less than 200 mW/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Conventional photodynamic therapy with red light and methyl aminolevulinate | Active comparator | PDT exposing the area to a red light source for 8 minutes with a spectrum of 630 nm and 37J/cm2, with the illumination intensity being less than 200 mW/cm2. Receives: Other: Full-dose illumination protocol |
| Half-dose illumination protocol photodynamic therapy with red light and methyl aminolevulinate | Experimental | PDT exposing the area to a red light source for 8 minutes with a spectrum of 630 nm and 18,5J/cm2, with the illumination intensity being less than 200 mW/cm2. Receives: Other: Half-dose illumination protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of 75% of the treated actinic keratosis at 3 months post-intervention.
Total count of actinic keratosis will be assessed
Measured: 3 months after de procedure
Secondary outcomes (2)
Tolerance during intervention
Pain assessed by Visual Analogue Scale (VAS), from 0 (no pain) to 10 (worst pain)
Measured: During the procedure
Histological grade of actinic keratosis in biopsies as well as relevant biomarkers
E-cadherin, MMPs, p53, UEA, HSP47 and CD117/c-kit presence on the tissue (from + to +++, depending on the intensity)
Measured: 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Naharro-Rodriguez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Investigators
- Jorge Naharro-Rodriguez, M.D., Principal investigator, No organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545396
- Sponsor's protocol ID
- 154/23
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trakatelli M, Ulrich C, del Marmol V, Euvrard S, Stockfleth E, Abeni D. Epidemiology of nonmelanoma skin cancer (NMSC) in Europe: accurate and comparable data are needed for effective public health monitoring and interventions. Br J Dermatol. 2007 May;156 Suppl 3:1-7. doi: 10.1111/j.1365-2133.2007.07861.x.
PubMed 17488399Rowert-Huber J, Patel MJ, Forschner T, Ulrich C, Eberle J, Kerl H, Sterry W, Stockfleth E. Actinic keratosis is an early in situ squamous cell carcinoma: a proposal for reclassification. Br J Dermatol. 2007 May;156 Suppl 3:8-12. doi: 10.1111/j.1365-2133.2007.07860.x.
PubMed 17488400Wheller L, Soyer HP. Clinical features of actinic keratoses and early squamous cell carcinoma. Curr Probl Dermatol. 2015;46:58-63. doi: 10.1159/000366536. Epub 2014 Dec 18.
PubMed 25561207Siegel JA, Korgavkar K, Weinstock MA. Current perspective on actinic keratosis: a review. Br J Dermatol. 2017 Aug;177(2):350-358. doi: 10.1111/bjd.14852. Epub 2016 Aug 8.
PubMed 27500794Chen SC, Hill ND, Veledar E, Swetter SM, Weinstock MA. Reliability of quantification measures of actinic keratosis. Br J Dermatol. 2013 Dec;169(6):1219-22. doi: 10.1111/bjd.12591.
PubMed 24033340Schmitz L, Gupta G, Stucker M, Doerler M, Gambichler T, Welzel J, Szeimies RM, Bierhoff E, Stockfleth E, Dirschka T. Evaluation of two histological classifications for actinic keratoses - PRO classification scored highest inter-rater reliability. J Eur Acad Dermatol Venereol. 2019 Jun;33(6):1092-1097. doi: 10.1111/jdv.15580. Epub 2019 Apr 3.
PubMed 30887613Willenbrink TJ, Ruiz ES, Cornejo CM, Schmults CD, Arron ST, Jambusaria-Pahlajani A. Field cancerization: Definition, epidemiology, risk factors, and outcomes. J Am Acad Dermatol. 2020 Sep;83(3):709-717. doi: 10.1016/j.jaad.2020.03.126. Epub 2020 May 7.
PubMed 32387665Fernandez-Guarino M, Fonda Pascual P, Lizuain Gomez P, Harto Castano A, Jaen Olasolo P. Split-face study comparing conventional MAL photodynamic therapy in multiple actinic keratosis with complete time vs. half-time red light LED conventional illumination. J Eur Acad Dermatol Venereol. 2019 Aug;33(8):1529-1534. doi: 10.1111/jdv.15566. Epub 2019 Apr 15.
PubMed 30868672Novak B, Heesen L, Schary N, Lubbert H. The influence of different illumination parameters on protoporphyrin IX induced cell death in squamous cell carcinoma cells. Photodiagnosis Photodyn Ther. 2018 Mar;21:385-392. doi: 10.1016/j.pdpdt.2018.02.007. Epub 2018 Feb 7.
PubMed 29427796Campione E, Di Prete M, Di Raimondo C, Costanza G, Palumbo V, Garofalo V, Mazzilli S, Franceschini C, Dika E, Bianchi L, Orlandi A. Topical Treatment of Actinic Keratosis and Metalloproteinase Expression: A Clinico-Pathological Retrospective Study. Int J Mol Sci. 2022 Sep 26;23(19):11351. doi: 10.3390/ijms231911351.
PubMed 36232651Bobyr I, Campanati A, Consales V, Martina E, Molinelli E, Diotallevi F, Brisigotti V, Giangiacomi M, Ganzetti G, Giuliodori K, Offidani A. Ingenol mebutate in actinic keratosis: a clinical, videodermoscopic and immunohistochemical study. J Eur Acad Dermatol Venereol. 2017 Feb;31(2):260-266. doi: 10.1111/jdv.13831. Epub 2016 Jul 25.
PubMed 27453064
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization Of The Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For The Treatment Of Actinic Keratoses And Their Cancerization Field
- ClinicalTrials.gov ID
- NCT06545396
- Acronym / sponsor ID
- 154/23
- Conditions
- Actinic Keratoses
- Keywords
- Photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 9 Aug 2024 (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.
The goal of this clinical trial is to compare the tolerance and efficacy of conventional photodynamic therapy (PDT) with red light versus PDT with red light at half dose of illumination, as well as the changes produced by both interventions at the biomolecular level in patients with multiple actinic keratosis on the scalp. The main questions it aims to answer are:
Does PDT with half-dose illumination protocol maintain clinical and biomolecular efficacy?
Does PDT with half-dose illumination protocol improve intervention tolerance?
Researchers will compare both treatment protocols using the patient as its own control.
Participants scalp will be divided in two halves, one will be treated with PDT at conventional doses and the other with the half-dose illumination protocol, a skin biopsy will be obtained both pre and post-treatment of each of the areas. Variables will be assessed during the 3 visits of the study.
Detailed description
The goal of the clinical trial is to compare efficacy and tolerance of photodynamic therapy (PDT) with red light at half dose illumination protocol with conventional PDT for the treatment of grade I and II actinic keratosis. The main hypotheses is that half-light protocol PDT could maintain efficacy while improving tolerance of the procedure.
With this aim the investigators will compare the efficacy of the clinical response after field treatment with photodynamic therapy with red light at half dose versus conventional photodynamic therapy with standard red light in patients with scalp actinic keratoses as well as determine changes in molecular biomarkers at the histological and immunohistochemical level pre- and post-treatment with conventional PDT and PDT with red light at half dose.
The included patients will have their scalp divided into two halves of similar size using the interparietal line as a separation method; one half will be treated with conventional PDT and the other half with half-dose PDT. This is a comparative study between two treatment modalities, both of which will be applied to all patients, and in half of the sample, four skin biopsies of the affected area (two pre and tw post-treatment) will also be performed to conduct an immunohistochemical analysis of the skin samples. Both treatment protocols will be compared using the patient as his or her own protocol. Variables will be assessed during the 3 visits of the study (baseline, 3 months and 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional photodynamic therapy with red light and methyl aminolevulinate | Active comparator | Other: Full-dose illumination protocolPDT exposing the area to a red light source for 8 minutes with a spectrum of 630 nm and 37J/cm2, with the illumination intensity being less than 200 mW/cm2. |
| Half-dose illumination protocol photodynamic therapy with red light and methyl aminolevulinate | Experimental | Other: Half-dose illumination protocolPDT exposing the area to a red light source for 8 minutes with a spectrum of 630 nm and 18,5J/cm2, with the illumination intensity being less than 200 mW/cm2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with grade I and II actinic keratoses (AK) of Olsen on the scalp requiring field cancerization treatment.
- ≥ 18 years old.
- More than 5 AK per field of cancerization to be treated.
- More than 6 months since the last field treatment for AK performed.
- No AK in clinical grade III progression of Olsen or showing signs suggestive of being invasive squamous cell carcinoma.
Key exclusion criteria (4 listed)
- Patients with photodermatoses.
- Patients sensitive to methyl-aminolevulinate.
- Patients with disabilities or unable to provide informed consent.
- Patients who do not tolerate or do not wish to be treated with 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 |
|---|---|---|
| Half-dose illumination protocolArea will be treated according to the classic protocol, in a single session. First, the surface of the actinic keratoses will be scraped to remove scales and crusts. Using a spatula, a sufficient amount of photosensitizing cream will be applied to cover the treatment area (1 mm thick). The treated area will then be covered with an occlusive dressing for 3 hours. After this interval, the dressing will be removed and the area will be exposed to a red light source for 8 minutes with a spectrum of 630 nm and 18,5J/cm2, with the illumination intensity being less than 200 mW/cm2. | Other | Half-dose illumination protocol photodynamic therapy with red light and methyl aminolevulinate |
| Full-dose illumination protocolArea will be treated according to the classic protocol, in a single session. First, the surface of the actinic keratoses will be scraped to remove scales and crusts. Using a spatula, a sufficient amount of photosensitizing cream will be applied to cover the treatment area (1 mm thick). The treated area will then be covered with an occlusive dressing for 3 hours. After this interval, the dressing will be removed and the area will be exposed to a red light source for 8 minutes with a spectrum of 630 nm and 37J/cm2, with the illumination intensity being less than 200 mW/cm2. | Other | Conventional photodynamic therapy with red light and methyl aminolevulinate |
Primary outcome
Response of 75% of the treated actinic keratosis at 3 months post-intervention.
Time frame: 3 months after de procedure
Total count of actinic keratosis will be assessed
2 secondary outcomes
Tolerance during intervention
Time frame: During the procedure
Histological grade of actinic keratosis in biopsies as well as relevant biomarkers
Time frame: 3 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Results publication: PubMed 17488399Trakatelli M, Ulrich C, del Marmol V, Euvrard S, Stockfleth E, Abeni D. Epidemiology of nonmelanoma skin cancer (NMSC) in Europe: accurate and comparable data are needed for effective public health monitoring and interventions. Br J Dermatol. 2007 May;156 Suppl 3:1-7. doi: 10.1111/j.1365-2133.2007.07861.x.
- Results publication: PubMed 17488400Rowert-Huber J, Patel MJ, Forschner T, Ulrich C, Eberle J, Kerl H, Sterry W, Stockfleth E. Actinic keratosis is an early in situ squamous cell carcinoma: a proposal for reclassification. Br J Dermatol. 2007 May;156 Suppl 3:8-12. doi: 10.1111/j.1365-2133.2007.07860.x.
- Results publication: PubMed 25561207Wheller L, Soyer HP. Clinical features of actinic keratoses and early squamous cell carcinoma. Curr Probl Dermatol. 2015;46:58-63. doi: 10.1159/000366536. Epub 2014 Dec 18.
- Results publication: PubMed 27500794Siegel JA, Korgavkar K, Weinstock MA. Current perspective on actinic keratosis: a review. Br J Dermatol. 2017 Aug;177(2):350-358. doi: 10.1111/bjd.14852. Epub 2016 Aug 8.
- Results publication: PubMed 24033340Chen SC, Hill ND, Veledar E, Swetter SM, Weinstock MA. Reliability of quantification measures of actinic keratosis. Br J Dermatol. 2013 Dec;169(6):1219-22. doi: 10.1111/bjd.12591.
- Results publication: PubMed 30887613Schmitz L, Gupta G, Stucker M, Doerler M, Gambichler T, Welzel J, Szeimies RM, Bierhoff E, Stockfleth E, Dirschka T. Evaluation of two histological classifications for actinic keratoses - PRO classification scored highest inter-rater reliability. J Eur Acad Dermatol Venereol. 2019 Jun;33(6):1092-1097. doi: 10.1111/jdv.15580. Epub 2019 Apr 3.
- Results publication: PubMed 32387665Willenbrink TJ, Ruiz ES, Cornejo CM, Schmults CD, Arron ST, Jambusaria-Pahlajani A. Field cancerization: Definition, epidemiology, risk factors, and outcomes. J Am Acad Dermatol. 2020 Sep;83(3):709-717. doi: 10.1016/j.jaad.2020.03.126. Epub 2020 May 7.
- Results publication: PubMed 30868672Fernandez-Guarino M, Fonda Pascual P, Lizuain Gomez P, Harto Castano A, Jaen Olasolo P. Split-face study comparing conventional MAL photodynamic therapy in multiple actinic keratosis with complete time vs. half-time red light LED conventional illumination. J Eur Acad Dermatol Venereol. 2019 Aug;33(8):1529-1534. doi: 10.1111/jdv.15566. Epub 2019 Apr 15.
- Results publication: PubMed 29427796Novak B, Heesen L, Schary N, Lubbert H. The influence of different illumination parameters on protoporphyrin IX induced cell death in squamous cell carcinoma cells. Photodiagnosis Photodyn Ther. 2018 Mar;21:385-392. doi: 10.1016/j.pdpdt.2018.02.007. Epub 2018 Feb 7.
- Results publication: PubMed 36232651Campione E, Di Prete M, Di Raimondo C, Costanza G, Palumbo V, Garofalo V, Mazzilli S, Franceschini C, Dika E, Bianchi L, Orlandi A. Topical Treatment of Actinic Keratosis and Metalloproteinase Expression: A Clinico-Pathological Retrospective Study. Int J Mol Sci. 2022 Sep 26;23(19):11351. doi: 10.3390/ijms231911351.
- Results publication: PubMed 27453064Bobyr I, Campanati A, Consales V, Martina E, Molinelli E, Diotallevi F, Brisigotti V, Giangiacomi M, Ganzetti G, Giuliodori K, Offidani A. Ingenol mebutate in actinic keratosis: a clinical, videodermoscopic and immunohistochemical study. J Eur Acad Dermatol Venereol. 2017 Feb;31(2):260-266. doi: 10.1111/jdv.13831. Epub 2016 Jul 25.
- Individual participant dataSharing planned: No
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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.
Jorge Naharro-Rodriguez, M.D. principal investigator
No organization
Questions about this trial
What is this clinical trial studying?
A study testing Half-dose illumination protocol and Full-dose illumination protocol in people with Actinic Keratoses, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal.
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 5 inclusion and 4 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Jorge Naharro-Rodriguez, M.D. (913368000 ext. +34, irycis@irycis.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of 75% of the treated actinic keratosis at 3 months post-intervention. (time frame: 3 months after de procedure). 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 NCT06545396, which also lists 11 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 9 Aug 2024.