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

NCT06507644 | Not Yet Recruiting

• 1 other identifier: 6.715.052
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (28)

• Treatment success baseline

  baseline

• Treatment success 30 days

  30 days

• Treatment success 3 months

  3 months

• Treatment success 6 months

  6 months

• Actinic keratoses recurrence rate 30 days

  30 days

Study Arms (4)

- 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).

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).

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).

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).

Procedure: light curettage; Other: Pre irradiation of 1 hour; Other: topical application of 8% methyl aminolevulinate photosensitizer MAL; Device: Visible light source

Interventions

light curettage 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.

- 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 hour 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.

Experimental Group (16% MAL incubation time - 1 hour); Experimental Group (8% MAL incubation time - 1 hour)

Pre irradiation of 3 hour 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.

- 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 MAL OTHER

Participants will be treated with 8% topical MAL photosensitizer

Experimental Group (8% MAL incubation time - 1 hour); Experimental Group (8% MAL incubation time - 3 hour)

topical application of 16% methyl aminolevulinate photosensitizer (MAL) OTHER

Participants will be treated with 16% topical MAL photosensitizer

- Control Group (gold standard - 16% MAL with 3-hour incubation time); Experimental Group (16% MAL incubation time - 1 hour)

Visible light source DEVICE

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

- 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)

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ricardo Hideyoshi Kitamura, PhD

CONTACT

11982807810; annacrth@gmail.com

Anna CR Horliana, PhD

CONTACT

13981999848; annacrth@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: A Double-Blind Randomized Controlled Clinical Protocol

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 18, 2024
• Study Start: November 30, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10