Methyl Aminolevulinate 8% and 16% Incubated by 1 and 3 for Actinic Keratoses Treatment
NCT Number: NCT06507644
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Actinic Keratoses
Interventions: PROCEDURE: light curettage|OTHER: Pre irradiation of 1 hour|OTHER: Pre irradiation of 3 hour|OTHER: topical application of 8% methyl aminolevulinate photosensitizer MAL|OTHER: topical application of 16% methyl aminolevulinate photosensitizer (MAL)|DEVICE: Visible light source
Sponsor: University of Nove de Julho
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-30
Completion Date: 2026-04-30

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. 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.

Primary Outcome Measures: 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., 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., 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., 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., 6 months
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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)., 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)., 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)., 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)., 6 months