Methyl Aminolevulinate 8% and 16% Incubated by 1 and 3 for Actinic Keratoses Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2026-05-30

Brief Summary

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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.

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Detailed Description

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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

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Actinic Keratoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Double-Blind Randomized Controlled Clinical Protocol

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Only the researcher responsible for performing the treatments (who will open the randomization envelopes) will know which treatment is assigned to each participant. The group identification will be revealed only after statistical data analysis to all involved in the study by this researcher. Therefore, the researcher responsible for data collection and their assistant will be blinded to the treatments assigned to the groups. The participant will be blinded to the type of treatment performed, as will the statistician.

Study Groups

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- Control Group (gold standard - 16% MAL with 3-hour incubation time)

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).

Group Type ACTIVE_COMPARATOR

light curettage

Intervention Type PROCEDURE

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 3 hour

Intervention Type OTHER

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 16% methyl aminolevulinate photosensitizer (MAL)

Intervention Type OTHER

Participants will be treated with 16% topical MAL photosensitizer

Visible light source

Intervention Type DEVICE

Skin illumination will be performed using a visible light source (LED) with a wavelength of 643 nm

Experimental Group (16% MAL incubation time - 1 hour)

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).

Group Type EXPERIMENTAL

light curettage

Intervention Type PROCEDURE

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 hour

Intervention Type OTHER

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.

topical application of 16% methyl aminolevulinate photosensitizer (MAL)

Intervention Type OTHER

Participants will be treated with 16% topical MAL photosensitizer

Visible light source

Intervention Type DEVICE

Skin illumination will be performed using a visible light source (LED) with a wavelength of 643 nm

Experimental Group (8% MAL incubation time - 3 hour)

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).

Group Type EXPERIMENTAL

light curettage

Intervention Type PROCEDURE

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 3 hour

Intervention Type OTHER

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 MAL

Intervention Type OTHER

Participants will be treated with 8% topical MAL photosensitizer

Visible light source

Intervention Type DEVICE

Skin illumination will be performed using a visible light source (LED) with a wavelength of 643 nm

Experimental Group (8% MAL incubation time - 1 hour)

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).

Group Type EXPERIMENTAL

light curettage

Intervention Type PROCEDURE

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 hour

Intervention Type OTHER

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.

topical application of 8% methyl aminolevulinate photosensitizer MAL

Intervention Type OTHER

Participants will be treated with 8% topical MAL photosensitizer

Visible light source

Intervention Type DEVICE

Skin illumination will be performed using a visible light source (LED) with a wavelength of 643 nm

Interventions

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light curettage

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.

Intervention Type PROCEDURE

Pre irradiation of 1 hour

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.

Intervention Type OTHER

Pre irradiation of 3 hour

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.

Intervention Type OTHER

topical application of 8% methyl aminolevulinate photosensitizer MAL

Participants will be treated with 8% topical MAL photosensitizer

Intervention Type OTHER

topical application of 16% methyl aminolevulinate photosensitizer (MAL)

Participants will be treated with 16% topical MAL photosensitizer

Intervention Type OTHER

Visible light source

Skin illumination will be performed using a visible light source (LED) with a wavelength of 643 nm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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),
* 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes