Actinic KeratosesNCT06507644
Methyl Aminolevulinate 8% and 16% Incubated by 1 and 3 for Actinic Keratoses Treatment
A study testing light curettage, Pre irradiation of 1 hour and Pre irradiation of 3 hour in people with Actinic Keratoses, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The objective of this protocol is to compare the efficacy of the topical application of MAL at concentrations of 8% and 16%, mediated by red light, as well as to evaluate the impact of different incubation times (1 or 3 hours) in the treatment of actinic keratoses on the face, with a 6-month follow-up. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- light curettage, Pre irradiation of 1 hour and Pre irradiation of 3 hour
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Nov 2024to 30 May 2026
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals of both sexes,
- Aged between 40 and 90 years,
- Fitzpatrick skin phototypes I to IV,
- Photodamaged skin with at least five clinically evident actinic keratosis lesions on the face to be treated,
- No prior treatment for at least six months.
Who cannot join
- Clinically diagnosed infiltrative lesions, as the gold standard treatment is surgical with histopathological evaluation of the lesion (surgery will be performed at no cost to the participant), who will receive guidance and referral for appropriate treatment.
- Photosensitive diseases, such as systemic lupus erythematosus, dermatomyositis, porphyria, among others.
- History of arsenic exposure,
- Known allergy to MAL or similar photosensitizing agents,
- Psychoactive drug abuse,
- Previous radiotherapy at the lesion site(s),
Show all 12Show fewer
- Participation in another clinical trial,
- Intense tanning at the time of treatment,
- Pregnant or breastfeeding women,
- Local or systemic infection,
- Immunosuppression: uncompensated chronic diseases or emotional disorders considered contraindications to treatment,
- Skin conditions on the neck and anterior chest.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Topical Application of Methyl Aminolevulinate 8% and 16% Mediated by Red Light and Incubation Time of 1 and 3 Hours in the Treatment of Actinic Keratoses on the Face: A Double-Blind Randomized Controlled Clinical Protocol
The objective of this protocol is to compare the efficacy of the topical application of MAL at concentrations of 8% and 16%, mediated by red light, as well as to evaluate the impact of different incubation times (1 or 3 hours) in the treatment of actinic keratoses on the face, with a 6-month follow-up. This parallel-arm, 6-month follow-up randomized controlled clinical trial will consist of 4 groups: G1 - Control Group - MAL 16% irradiated with 643nm and 75J/cm² and 3-hour incubation time (n=36), G2 - MAL 16% and 1-hour incubation (n=36), G3 - MAL 8% - 3 hours (n=36), and G4 - MAL 8% - 1 hour (n=36). The researcher conducting the collection and the participant will be blinded to the interventions. The primary outcome will be the complete remission of the lesion at 6 months. Secondary outcomes will include treatment success (75% reduction in the initial number of lesions), recurrence rate, emergence of SCC, incidence of adverse effects, and improvement in skin texture, wrinkles, and pigmentation using a validated scale. All outcomes will be assessed at 30 days, 3, and 6 months. Quality of life will be evaluated using the Actinic Keratosis Quality of Life questionnaire (AKQoL) at 6 months.
Read the detailed description
The multifocality of actinic keratosis, the unpredictability of lesion evolution with potential progression to squamous cell carcinoma (SCC), and the consequent risk of local extension and metastasis, alongside the recent development of new therapies, make the selection of a therapeutic regimen challenging. The increasing incidence associated economic costs, and impact on quality of life have fostered interest in studying protocols for treating this severe skin condition. The topical application of 16% methyl aminolevulinate (MAL) is well-established in the literature for its local therapeutic effects and ease of application. However, the high cost of medication, long incubation time, and adverse effects such as itching and burning in some patients limit the dissemination of this treatment. Studies are needed to test other protocols of this promising therapy to increase acceptance among patients and professionals. Therefore, the objective of this protocol is to compare the efficacy of the topical application of MAL at concentrations of 8% and 16%, mediated by red light, as well as to evaluate the impact of different incubation times (1 or 3 hours) in the treatment of actinic keratoses on the face, with a 6-month follow-up. This parallel-arm, 6-month follow-up randomized controlled clinical trial will consist of 4 groups: G1 - Control Group - MAL 16% irradiated with 643nm and 75J/cm² and 3-hour incubation time (n=36), G2 - MAL 16% and 1-hour incubation (n=36), G3 - MAL 8% - 3 hours (n=36), and G4 - MAL 8% - 1 hour (n=36). The researcher conducting the collection and the participant will be blinded to the interventions. The primary outcome will be the complete remission of the lesion at 6 months. Secondary outcomes will include treatment success (75% reduction in the initial number of lesions), recurrence rate, emergence of SCC, incidence of adverse effects, and improvement in skin texture, wrinkles, and pigmentation using a validated scale. All outcomes will be assessed at 30 days, 3, and 6 months. Quality of life will be assessed using the Actinic Keratosis Quality of Life questionnaire (AKQoL) at 6 months. If data are normal, they will be subjected to 3-way ANOVA and presented as means ± standard deviation (SD). Otherwise, they will be presented as median and interquartile range and compared using the Kruskall-Wallis and Friedman tests. Categorical variables will be evaluated with the chi-square test, Fisher's exact test, or likelihood ratio test. A p-value < 0.05 will be considered significant.
- Conditions
- Actinic Keratoses
- Being tested
- light curettage, Pre irradiation of 1 hour, Pre irradiation of 3 hour, topical application of 8% methyl aminolevulinate photosensitizer MAL, topical application of 16% methyl aminolevulinate photosensitizer (MAL)
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light curettageProcedure or surgery
Before the treatment, the treated area will be degreased with 0.2% aqueous chlorhexidine. Next, a light curettage will be performed on the face with a sterile curette.
Pre irradiation of 1 hourOther
A thin layer of the photosensitizing medication, approximately 1 mm thick, will be applied to the participant's facial lesion sites. Then an occlusive dressing will be used to enhance MAL penetration, which will be covered with aluminum foil to prevent ambient light from influencing the protoporphyrin production process. For the PDT technique, the dressing will remain on the face for 1 hour.
Pre irradiation of 3 hourOther
A thin layer of the photosensitizing medication, approximately 1 mm thick, will be applied to the participant's facial lesion sites. Then an occlusive dressing will be used to enhance MAL penetration, which will be covered with aluminum foil to prevent ambient light from influencing the protoporphyrin production process. For the PDT technique, the dressing will remain on the face for 3 hour.
topical application of 8% methyl aminolevulinate photosensitizer MALOther
Participants will be treated with 8% topical MAL photosensitizer
topical application of 16% methyl aminolevulinate photosensitizer (MAL)Other
Participants will be treated with 16% topical MAL photosensitizer
Visible light sourceDevice
Skin illumination will be performed using a visible light source (LED) with a wavelength of 643 nm
| Study group | Role | What they receive |
|---|---|---|
| - Control Group (gold standard - 16% MAL with 3-hour incubation time) | Active comparator | Participants will be treated with 16% topical MAL photosensitizer with a 3-hour incubation period. The light source used for skin illumination will be a visible light source (LED) with a wavelength of 643nm (Hygialux LLT1601®, KLD - ANVISA registration number 10245239012). Receives: Procedure: light curettage; Other: Pre irradiation of 3 hour; Other: topical application of 16% methyl aminolevulinate photosensitizer (MAL); Device: Visible light source |
| Experimental Group (16% MAL incubation time - 1 hour) | Experimental | Participants will be treated with 16% topical MAL photosensitizer with a 1-hour incubation period. The light source used for skin illumination will be a visible light source (LED) with a wavelength of 643nm (Hygialux LLT1601®, KLD - ANVISA registration number 10245239012). Receives: Procedure: light curettage; Other: Pre irradiation of 1 hour; Other: topical application of 16% methyl aminolevulinate photosensitizer (MAL); Device: Visible light source |
| Experimental Group (8% MAL incubation time - 3 hour) | Experimental | Participants will be treated with 8% topical MAL photosensitizer with a 3-hour incubation period. The light source used for skin illumination will be a visible light source (LED) with a wavelength of 643nm (Hygialux LLT1601®, KLD - ANVISA registration number 10245239012). Receives: Procedure: light curettage; Other: Pre irradiation of 3 hour; Other: topical application of 8% methyl aminolevulinate photosensitizer MAL; Device: Visible light source |
| Experimental Group (8% MAL incubation time - 1 hour) | Experimental | Participants will be treated with 8% topical MAL photosensitizer with a 1-hour incubation period. The light source used for skin illumination will be a visible light source (LED) with a wavelength of 643nm (Hygialux LLT1601®, KLD - ANVISA registration number 10245239012). Receives: Procedure: light curettage; Other: Pre irradiation of 1 hour; Other: topical application of 8% methyl aminolevulinate photosensitizer MAL; Device: Visible light source |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission baseline
Quantitative evaluation: A count of the number of lesions with complete response, i.e., those that show total disappearance measurable after treatment, will be performed. These lesions will be clinically evaluated and the number of lesions at these periods will be compared with the initial value (baseline). Both the absolute and relative number of lesions will be considered. To avoid variability in counting, only one researcher will perform the counts.
Measured: baseline
Complete remission -30 days
Quantitative evaluation: A count of the number of lesions with complete response, i.e., those that show total disappearance measurable after treatment, will be performed. These lesions will be clinically evaluated and the number of lesions at these periods will be compared with the initial value (baseline). Both the absolute and relative number of lesions will be considered. To avoid variability in counting, only one researcher will perform the counts.
Measured: 30 days
Complete remission - 3 months
Quantitative evaluation: A count of the number of lesions with complete response, i.e., those that show total disappearance measurable after treatment, will be performed. These lesions will be clinically evaluated and the number of lesions at these periods will be compared with the initial value (baseline). Both the absolute and relative number of lesions will be considered. To avoid variability in counting, only one researcher will perform the counts.
Measured: 3 months
Complete remission - 6 months
Quantitative evaluation: A count of the number of lesions with complete response, i.e., those that show total disappearance measurable after treatment, will be performed. These lesions will be clinically evaluated and the number of lesions at these periods will be compared with the initial value (baseline). Both the absolute and relative number of lesions will be considered. To avoid variability in counting, only one researcher will perform the counts.
Measured: 6 months
Secondary outcomes (28)
Treatment success baseline
Evaluation of the proportion of participants who show at least a 75% reduction in the initial number of actinic keratosis lesions in the treatment area after the last day of treatment.
Measured: baseline
Treatment success 30 days
Evaluation of the proportion of participants who show at least a 75% reduction in the initial number of actinic keratosis lesions in the treatment area after the last day of treatment.
Measured: 30 days
Treatment success 3 months
Evaluation of the proportion of participants who show at least a 75% reduction in the initial number of actinic keratosis lesions in the treatment area after the last day of treatment.
Measured: 3 months
Treatment success 6 months
Evaluation of the proportion of participants who show at least a 75% reduction in the initial number of actinic keratosis lesions in the treatment area after the last day of treatment.
Measured: 6 months
Actinic keratoses recurrence rate 30 days
Defined as the reappearance of lesions in previously treated areas. Recurrence evaluation will occur at the same follow-up periods of the study, i.e., at 30 days, 3 months, and 6 months after the end of treatment. Recurrent lesions will be quantified, considering both the absolute and relative number of lesions. These lesions will be monitored and re-treated at the end of the study, unless malignization occurs, in which case they will be treated immediately.
Measured: 30 days
Actinic keratoses recurrence rate 3 months
Defined as the reappearance of lesions in previously treated areas. Recurrence evaluation will occur at the same follow-up periods of the study, i.e., at 30 days, 3 months, and 6 months after the end of treatment. Recurrent lesions will be quantified, considering both the absolute and relative number of lesions. These lesions will be monitored and re-treated at the end of the study, unless malignization occurs, in which case they will be treated immediately.
Measured: 3 months
Actinic keratoses recurrence rate 6 months
Defined as the reappearance of lesions in previously treated areas. Recurrence evaluation will occur at the same follow-up periods of the study, i.e., at 30 days, 3 months, and 6 months after the end of treatment. Recurrent lesions will be quantified, considering both the absolute and relative number of lesions. These lesions will be monitored and re-treated at the end of the study, unless malignization occurs, in which case they will be treated immediately.
Measured: 6 months
Prevention of squamous cell carcinoma 30 days
If malignization of the lesion occurs during the follow-up period, the gold standard treatment, which consists of surgical intervention, will be applied. Participants will be continuously monitored to prevent the development of squamous cell carcinoma in the treatment area throughout the study. The participation of these participants will be maintained, as the follow-ups consist only of follow-up evaluations. The quantification of malignant lesions will be carried out, considering both the absolute and relative numbers.
Measured: 30 days
Prevention of squamous cell carcinoma 3 months
If malignization of the lesion occurs during the follow-up period, the gold standard treatment, which consists of surgical intervention, will be applied. Participants will be continuously monitored to prevent the development of squamous cell carcinoma in the treatment area throughout the study. The participation of these participants will be maintained, as the follow-ups consist only of follow-up evaluations. The quantification of malignant lesions will be carried out, considering both the absolute and relative numbers.
Measured: 3 months
Prevention of squamous cell carcinoma 6 months
If malignization of the lesion occurs during the follow-up period, the gold standard treatment, which consists of surgical intervention, will be applied. Participants will be continuously monitored to prevent the development of squamous cell carcinoma in the treatment area throughout the study. The participation of these participants will be maintained, as the follow-ups consist only of follow-up evaluations. The quantification of malignant lesions will be carried out, considering both the absolute and relative numbers.
Measured: 6 months
Incidence of adverse effects 30 days
The incidence of adverse effects, such as erythema, edema, itching, and peeling, will be monitored through a personal diary filled out by the participant, in which detailed descriptions of any adverse effects will be recorded. This method, as recommended by Jansen et al. (2019), will allow participants to report their symptoms individually. The responsible researcher, a dermatologist specializing in this type of treatment, will offer continuous assistance and follow-up, remaining accessible whenever necessary.
Measured: 30 days
Incidence of adverse effects 3 months
The incidence of adverse effects, such as erythema, edema, itching, and peeling, will be monitored through a personal diary filled out by the participant, in which detailed descriptions of any adverse effects will be recorded. This method, as recommended by Jansen et al. (2019), will allow participants to report their symptoms individually. The responsible researcher, a dermatologist specializing in this type of treatment, will offer continuous assistance and follow-up, remaining accessible whenever necessary.
Measured: 3 months
Incidence of adverse effects 6 months
The incidence of adverse effects, such as erythema, edema, itching, and peeling, will be monitored through a personal diary filled out by the participant, in which detailed descriptions of any adverse effects will be recorded. This method, as recommended by Jansen et al. (2019), will allow participants to report their symptoms individually. The responsible researcher, a dermatologist specializing in this type of treatment, will offer continuous assistance and follow-up, remaining accessible whenever necessary.
Measured: 6 months
Subjective pain assessment 30 days
Subjective pain assessment will be conducted using the Visual Analog Scale (VAS), consisting of a 10 mm line with closed ends, indicating '0' for no pain and '10' for unbearable pain, the worst pain ever felt. Instructions for marking will be consistently provided by the same operator. Each participant will be instructed to mark with a vertical line the point that best reflects the intensity of the pain at the time of evaluation (Heller et al., 2016). These evaluations will be performed weekly until 30 days after treatment, followed by assessments at 3 and 6 months.
Measured: 30 days
Subjective pain assessment 3 months
Subjective pain assessment will be conducted using the Visual Analog Scale (VAS), consisting of a 10 mm line with closed ends, indicating '0' for no pain and '10' for unbearable pain, the worst pain ever felt. Instructions for marking will be consistently provided by the same operator. Each participant will be instructed to mark with a vertical line the point that best reflects the intensity of the pain at the time of evaluation (Heller et al., 2016). These evaluations will be performed weekly until 30 days after treatment, followed by assessments at 3 and 6 months.
Measured: 3 months
Subjective pain assessment 6 months
Subjective pain assessment will be conducted using the Visual Analog Scale (VAS), consisting of a 10 mm line with closed ends, indicating '0' for no pain and '10' for unbearable pain, the worst pain ever felt. Instructions for marking will be consistently provided by the same operator. Each participant will be instructed to mark with a vertical line the point that best reflects the intensity of the pain at the time of evaluation (Heller et al., 2016). These evaluations will be performed weekly until 30 days after treatment, followed by assessments at 3 and 6 months.
Measured: 6 months
Rescue medication 30 days
Rescue medication will be evaluated by the standardized amount of analgesics ingested (paracetamol). At the beginning of the study, each participant will receive a blister pack of paracetamol®, a drug with a purely analgesic effect, as recommended by Jóźwiak-Bebenista (2014). Participants are instructed to keep the blister pack until the end of the experiment and bring it to each consultation. At the end of the study, the amount of tablets used will be evaluated in each group as a parameter for measuring pain.
Measured: 30 days
Rescue medication 3 months
Rescue medication will be evaluated by the standardized amount of analgesics ingested (paracetamol). At the beginning of the study, each participant will receive a blister pack of paracetamol®, a drug with a purely analgesic effect, as recommended by Jóźwiak-Bebenista (2014). Participants are instructed to keep the blister pack until the end of the experiment and bring it to each consultation. At the end of the study, the amount of tablets used will be evaluated in each group as a parameter for measuring pain.
Measured: 3 months
Rescue medication 6 months
Rescue medication will be evaluated by the standardized amount of analgesics ingested (paracetamol). At the beginning of the study, each participant will receive a blister pack of paracetamol®, a drug with a purely analgesic effect, as recommended by Jóźwiak-Bebenista (2014). Participants are instructed to keep the blister pack until the end of the experiment and bring it to each consultation. At the end of the study, the amount of tablets used will be evaluated in each group as a parameter for measuring pain.
Measured: 6 months
Evaluation of skin texture, wrinkles, and pigmentation 30 days
This will be conducted at 30 days, 3 months, and 6 months, using the Tina Alster et al. (2005) scale. This scale, evaluated by professionals and participants themselves, classifies improvements as minimal (<25%), moderate (25%-50%), significant (51%-75%), and excellent (>75%). These evaluations will provide a comprehensive approach to measure the treatment's effectiveness over time.
Measured: 30 days
Evaluation of skin texture, wrinkles, and pigmentation 3 months
This will be conducted at 30 days, 3 months, and 6 months, using the Tina Alster et al. (2005) scale. This scale, evaluated by professionals and participants themselves, classifies improvements as minimal (<25%), moderate (25%-50%), significant (51%-75%), and excellent (>75%). These evaluations will provide a comprehensive approach to measure the treatment's effectiveness over time.
Measured: 3 months
Evaluation of skin texture, wrinkles, and pigmentation 6 months
This will be conducted at 30 days, 3 months, and 6 months, using the Tina Alster et al. (2005) scale. This scale, evaluated by professionals and participants themselves, classifies improvements as minimal (<25%), moderate (25%-50%), significant (51%-75%), and excellent (>75%). These evaluations will provide a comprehensive approach to measure the treatment's effectiveness over time.
Measured: 6 months
Participant satisfaction baseline
Will be assessed through the Actinic Keratosis Quality of Life questionnaire (AKQoL) (Esman et al., 2013) after 6 months and 1 year of treatment. The items will be scored on a standard 4-point Likert scale and summarized into a maximum total score of 32 points. A higher score indicates greater impairment in quality of life. The questionnaire has been translated and validated into Portuguese (Vilhena et al., 2022).
Measured: baseline
Participant satisfaction 30 days
Will be assessed through the Actinic Keratosis Quality of Life questionnaire (AKQoL) (Esman et al., 2013) after 6 months and 1 year of treatment. The items will be scored on a standard 4-point Likert scale and summarized into a maximum total score of 32 points. A higher score indicates greater impairment in quality of life. The questionnaire has been translated and validated into Portuguese (Vilhena et al., 2022).
Measured: 30 days
Participant satisfaction 3 months
Will be assessed through the Actinic Keratosis Quality of Life questionnaire (AKQoL) (Esman et al., 2013) after 6 months and 1 year of treatment. The items will be scored on a standard 4-point Likert scale and summarized into a maximum total score of 32 points. A higher score indicates greater impairment in quality of life. The questionnaire has been translated and validated into Portuguese (Vilhena et al., 2022).
Measured: 3 months
Participant satisfaction 6 months
Will be assessed through the Actinic Keratosis Quality of Life questionnaire (AKQoL) (Esman et al., 2013) after 6 months and 1 year of treatment. The items will be scored on a standard 4-point Likert scale and summarized into a maximum total score of 32 points. A higher score indicates greater impairment in quality of life. The questionnaire has been translated and validated into Portuguese (Vilhena et al., 2022).
Measured: 6 months
Satisfaction with Facial Appearance Overall
The FACE-Q (Satisfaction with Facial Appearance Overall) scale consists of nine items assessing satisfaction with overall facial appearance and geometry, using a four-point Likert scale (1 = very dissatisfied to 4 = very satisfied). The questionnaire should be administered before and after aesthetic treatment to measure the patient's perception of symmetry, proportion, and facial freshness. The total score ranges from 9 to 36 and is converted into a 0 to 100 scale, where higher scores indicate greater satisfaction.
Measured: baseline
Satisfaction with Facial Appearance Overall
The FACE-Q (Satisfaction with Facial Appearance Overall) scale consists of nine items assessing satisfaction with overall facial appearance and geometry, using a four-point Likert scale (1 = very dissatisfied to 4 = very satisfied). The questionnaire should be administered before and after aesthetic treatment to measure the patient's perception of symmetry, proportion, and facial freshness. The total score ranges from 9 to 36 and is converted into a 0 to 100 scale, where higher scores indicate greater satisfaction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start30 Nov 2024
- Primary completion30 Nov 2025
- Study completion30 May 2026
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Double-Blind Randomized Controlled Clinical Protocol
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507644
- Sponsor's protocol ID
- 6.715.052
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2024
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Application of Methyl Aminolevulinate 8% and 16% Mediated by Red Light and Incubation Time of 1 and 3 Hours in the Treatment of Actinic Keratoses on the Face: A Double-Blind Randomized Controlled Clinical Protocol
- ClinicalTrials.gov ID
- NCT06507644
- Acronym / sponsor ID
- 6.715.052
- Conditions
- Actinic Keratoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 18 Jul 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 objective of this protocol is to compare the efficacy of the topical application of MAL at concentrations of 8% and 16%, mediated by red light, as well as to evaluate the impact of different incubation times (1 or 3 hours) in the treatment of actinic keratoses on the face, with a 6-month follow-up. This parallel-arm, 6-month follow-up randomized controlled clinical trial will consist of 4 groups: G1 - Control Group - MAL 16% irradiated with 643nm and 75J/cm² and 3-hour incubation time (n=36), G2 - MAL 16% and 1-hour incubation (n=36), G3 - MAL 8% - 3 hours (n=36), and G4 - MAL 8% - 1 hour (n=36). The researcher conducting the collection and the participant will be blinded to the interventions. The primary outcome will be the complete remission of the lesion at 6 months. Secondary outcomes will include treatment success (75% reduction in the initial number of lesions), recurrence rate, emergence of SCC, incidence of adverse effects, and improvement in skin texture, wrinkles, and pigmentation using a validated scale. All outcomes will be assessed at 30 days, 3, and 6 months. Quality of life will be evaluated using the Actinic Keratosis Quality of Life questionnaire (AKQoL) at 6 months.
Detailed description
The multifocality of actinic keratosis, the unpredictability of lesion evolution with potential progression to squamous cell carcinoma (SCC), and the consequent risk of local extension and metastasis, alongside the recent development of new therapies, make the selection of a therapeutic regimen challenging. The increasing incidence associated economic costs, and impact on quality of life have fostered interest in studying protocols for treating this severe skin condition. The topical application of 16% methyl aminolevulinate (MAL) is well-established in the literature for its local therapeutic effects and ease of application. However, the high cost of medication, long incubation time, and adverse effects such as itching and burning in some patients limit the dissemination of this treatment. Studies are needed to test other protocols of this promising therapy to increase acceptance among patients and professionals. Therefore, the objective of this protocol is to compare the efficacy of the topical application of MAL at concentrations of 8% and 16%, mediated by red light, as well as to evaluate the impact of different incubation times (1 or 3 hours) in the treatment of actinic keratoses on the face, with a 6-month follow-up. This parallel-arm, 6-month follow-up randomized controlled clinical trial will consist of 4 groups: G1 - Control Group - MAL 16% irradiated with 643nm and 75J/cm² and 3-hour incubation time (n=36), G2 - MAL 16% and 1-hour incubation (n=36), G3 - MAL 8% - 3 hours (n=36), and G4 - MAL 8% - 1 hour (n=36). The researcher conducting the collection and the participant will be blinded to the interventions. The primary outcome will be the complete remission of the lesion at 6 months. Secondary outcomes will include treatment success (75% reduction in the initial number of lesions), recurrence rate, emergence of SCC, incidence of adverse effects, and improvement in skin texture, wrinkles, and pigmentation using a validated scale. All outcomes will be assessed at 30 days, 3, and 6 months. Quality of life will be assessed using the Actinic Keratosis Quality of Life questionnaire (AKQoL) at 6 months. If data are normal, they will be subjected to 3-way ANOVA and presented as means ± standard deviation (SD). Otherwise, they will be presented as median and interquartile range and compared using the Kruskall-Wallis and Friedman tests. Categorical variables will be evaluated with the chi-square test, Fisher's exact test, or likelihood ratio test. A p-value < 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A Double-Blind Randomized Controlled Clinical Protocol
| Arm | Type | Receives |
|---|---|---|
| - Control Group (gold standard - 16% MAL with 3-hour incubation time) | Active comparator | Procedure: light curettage, Other: Pre irradiation of 3 hour, Other: topical application of 16% methyl aminolevulinate photosensitizer (MAL), Device: Visible light sourceParticipants will be treated with 16% topical MAL photosensitizer with a 3-hour incubation period. The light source used for skin illumination will be a visible light source (LED) with a wavelength of 643nm (Hygialux LLT1601®, KLD - ANVISA registration number 10245239012). |
| Experimental Group (16% MAL incubation time - 1 hour) | Experimental | Procedure: light curettage, Other: Pre irradiation of 1 hour, Other: topical application of 16% methyl aminolevulinate photosensitizer (MAL), Device: Visible light sourceParticipants will be treated with 16% topical MAL photosensitizer with a 1-hour incubation period. The light source used for skin illumination will be a visible light source (LED) with a wavelength of 643nm (Hygialux LLT1601®, KLD - ANVISA registration number 10245239012). |
| Experimental Group (8% MAL incubation time - 3 hour) | Experimental | Procedure: light curettage, Other: Pre irradiation of 3 hour, Other: topical application of 8% methyl aminolevulinate photosensitizer MAL, Device: Visible light sourceParticipants will be treated with 8% topical MAL photosensitizer with a 3-hour incubation period. The light source used for skin illumination will be a visible light source (LED) with a wavelength of 643nm (Hygialux LLT1601®, KLD - ANVISA registration number 10245239012). |
| Experimental Group (8% MAL incubation time - 1 hour) | Experimental | Procedure: light curettage, Other: Pre irradiation of 1 hour, Other: topical application of 8% methyl aminolevulinate photosensitizer MAL, Device: Visible light sourceParticipants will be treated with 8% topical MAL photosensitizer with a 1-hour incubation period. The light source used for skin illumination will be a visible light source (LED) with a wavelength of 643nm (Hygialux LLT1601®, KLD - ANVISA registration number 10245239012). |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals of both sexes,
- Aged between 40 and 90 years,
- Fitzpatrick skin phototypes I to IV,
- Photodamaged skin with at least five clinically evident actinic keratosis lesions on the face to be treated,
- No prior treatment for at least six months.
Key exclusion criteria (12 listed)
- Clinically diagnosed infiltrative lesions, as the gold standard treatment is surgical with histopathological evaluation of the lesion (surgery will be performed at no cost to the participant), who will receive guidance and referral for appropriate treatment.
- Photosensitive diseases, such as systemic lupus erythematosus, dermatomyositis, porphyria, among others.
- History of arsenic exposure,
- Known allergy to MAL or similar photosensitizing agents,
- Psychoactive drug abuse,
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 |
|---|---|---|
| light curettageBefore the treatment, the treated area will be degreased with 0.2% aqueous chlorhexidine. Next, a light curettage will be performed on the face with a sterile curette. | Procedure or surgery | - Control Group (gold standard - 16% MAL with 3-hour incubation time), Experimental Group (16% MAL incubation time - 1 hour), Experimental Group (8% MAL incubation time - 1 hour), Experimental Group (8% MAL incubation time - 3 hour) |
| Pre irradiation of 1 hourA thin layer of the photosensitizing medication, approximately 1 mm thick, will be applied to the participant's facial lesion sites. Then an occlusive dressing will be used to enhance MAL penetration, which will be covered with aluminum foil to prevent ambient light from influencing the protoporphyrin production process. For the PDT technique, the dressing will remain on the face for 1 hour. | Other | Experimental Group (16% MAL incubation time - 1 hour), Experimental Group (8% MAL incubation time - 1 hour) |
| Pre irradiation of 3 hourA thin layer of the photosensitizing medication, approximately 1 mm thick, will be applied to the participant's facial lesion sites. Then an occlusive dressing will be used to enhance MAL penetration, which will be covered with aluminum foil to prevent ambient light from influencing the protoporphyrin production process. For the PDT technique, the dressing will remain on the face for 3 hour. | Other | - Control Group (gold standard - 16% MAL with 3-hour incubation time), Experimental Group (8% MAL incubation time - 3 hour) |
| topical application of 8% methyl aminolevulinate photosensitizer MALParticipants will be treated with 8% topical MAL photosensitizer | Other | Experimental Group (8% MAL incubation time - 1 hour), Experimental Group (8% MAL incubation time - 3 hour) |
| topical application of 16% methyl aminolevulinate photosensitizer (MAL)Participants will be treated with 16% topical MAL photosensitizer | Other | - Control Group (gold standard - 16% MAL with 3-hour incubation time), Experimental Group (16% MAL incubation time - 1 hour) |
| Visible light sourceSkin illumination will be performed using a visible light source (LED) with a wavelength of 643 nm | Device | - Control Group (gold standard - 16% MAL with 3-hour incubation time), Experimental Group (16% MAL incubation time - 1 hour), Experimental Group (8% MAL incubation time - 1 hour), Experimental Group (8% MAL incubation time - 3 hour) |
Primary outcome
Complete remission baseline
Time frame: baseline
Quantitative evaluation: A count of the number of lesions with complete response, i.e., those that show total disappearance measurable after treatment, will be performed. These lesions will be clinically evaluated and the number of lesions at these periods will be compared with the initial value (baseline). Both the absolute and relative number of lesions will be considered. To avoid variability in counting, only one researcher will perform the counts.
Complete remission -30 days
Time frame: 30 days
Quantitative evaluation: A count of the number of lesions with complete response, i.e., those that show total disappearance measurable after treatment, will be performed. These lesions will be clinically evaluated and the number of lesions at these periods will be compared with the initial value (baseline). Both the absolute and relative number of lesions will be considered. To avoid variability in counting, only one researcher will perform the counts.
Complete remission - 3 months
Time frame: 3 months
Quantitative evaluation: A count of the number of lesions with complete response, i.e., those that show total disappearance measurable after treatment, will be performed. These lesions will be clinically evaluated and the number of lesions at these periods will be compared with the initial value (baseline). Both the absolute and relative number of lesions will be considered. To avoid variability in counting, only one researcher will perform the counts.
Complete remission - 6 months
Time frame: 6 months
Quantitative evaluation: A count of the number of lesions with complete response, i.e., those that show total disappearance measurable after treatment, will be performed. These lesions will be clinically evaluated and the number of lesions at these periods will be compared with the initial value (baseline). Both the absolute and relative number of lesions will be considered. To avoid variability in counting, only one researcher will perform the counts.
28 secondary outcomes
Treatment success baseline
Time frame: baseline
Treatment success 30 days
Time frame: 30 days
Treatment success 3 months
Time frame: 3 months
Treatment success 6 months
Time frame: 6 months
Actinic keratoses recurrence rate 30 days
Time frame: 30 days
Actinic keratoses recurrence rate 3 months
Time frame: 3 months
Actinic keratoses recurrence rate 6 months
Time frame: 6 months
Prevention of squamous cell carcinoma 30 days
Time frame: 30 days
Prevention of squamous cell carcinoma 3 months
Time frame: 3 months
Prevention of squamous cell carcinoma 6 months
Time frame: 6 months
Incidence of adverse effects 30 days
Time frame: 30 days
Incidence of adverse effects 3 months
Time frame: 3 months
Incidence of adverse effects 6 months
Time frame: 6 months
Subjective pain assessment 30 days
Time frame: 30 days
Subjective pain assessment 3 months
Time frame: 3 months
Subjective pain assessment 6 months
Time frame: 6 months
Rescue medication 30 days
Time frame: 30 days
Rescue medication 3 months
Time frame: 3 months
Rescue medication 6 months
Time frame: 6 months
Evaluation of skin texture, wrinkles, and pigmentation 30 days
Time frame: 30 days
Evaluation of skin texture, wrinkles, and pigmentation 3 months
Time frame: 3 months
Evaluation of skin texture, wrinkles, and pigmentation 6 months
Time frame: 6 months
Participant satisfaction baseline
Time frame: baseline
Participant satisfaction 30 days
Time frame: 30 days
Participant satisfaction 3 months
Time frame: 3 months
Participant satisfaction 6 months
Time frame: 6 months
Satisfaction with Facial Appearance Overall
Time frame: baseline
Satisfaction with Facial Appearance Overall
Time frame: 6 months
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 29 Jul 2026.
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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 study testing light curettage, Pre irradiation of 1 hour and Pre irradiation of 3 hour in people with Actinic Keratoses, run by University of Nove de Julho 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 5 inclusion and 12 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 29 Jul 2026. 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?
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?
Complete remission baseline (time frame: baseline). The study lists 4 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 29 Jul 2026.