Trial Title:
Methyl Aminolevulinate 8% and 16% Incubated by 1 and 3 for Actinic Keratoses Treatment
NCT ID:
NCT06507644
Condition:
Actinic Keratoses
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A Double-Blind Randomized Controlled Clinical Protocol
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Procedure
Intervention name:
light curettage
Description:
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.
Arm group label:
- Control Group (gold standard - 16% MAL with 3-hour incubation time)
Arm group label:
Experimental Group (16% MAL incubation time - 1 hour)
Arm group label:
Experimental Group (8% MAL incubation time - 1 hour)
Arm group label:
Experimental Group (8% MAL incubation time - 3 hour)
Intervention type:
Other
Intervention name:
Pre irradiation of 1 hour
Description:
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.
Arm group label:
Experimental Group (16% MAL incubation time - 1 hour)
Arm group label:
Experimental Group (8% MAL incubation time - 1 hour)
Intervention type:
Other
Intervention name:
Pre irradiation of 3 hour
Description:
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.
Arm group label:
- Control Group (gold standard - 16% MAL with 3-hour incubation time)
Arm group label:
Experimental Group (8% MAL incubation time - 3 hour)
Intervention type:
Other
Intervention name:
topical application of 8% methyl aminolevulinate photosensitizer MAL
Description:
Participants will be treated with 8% topical MAL photosensitizer
Arm group label:
Experimental Group (8% MAL incubation time - 1 hour)
Arm group label:
Experimental Group (8% MAL incubation time - 3 hour)
Intervention type:
Other
Intervention name:
topical application of 16% methyl aminolevulinate photosensitizer (MAL)
Description:
Participants will be treated with 16% topical MAL photosensitizer
Arm group label:
- Control Group (gold standard - 16% MAL with 3-hour incubation time)
Arm group label:
Experimental Group (16% MAL incubation time - 1 hour)
Intervention type:
Device
Intervention name:
Visible light source
Description:
Skin illumination will be performed using a visible light source (LED) with a wavelength
of 643 nm
Arm group label:
- Control Group (gold standard - 16% MAL with 3-hour incubation time)
Arm group label:
Experimental Group (16% MAL incubation time - 1 hour)
Arm group label:
Experimental Group (8% MAL incubation time - 1 hour)
Arm group label:
Experimental Group (8% MAL incubation time - 3 hour)
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
40 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
November 30, 2024
Completion date:
May 30, 2026
Lead sponsor:
Agency:
University of Nove de Julho
Agency class:
Other
Source:
University of Nove de Julho
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06507644
