Clinical trial · Interventional
Methyl Aminolevulinate 8% and 16% Incubated by 1 and 3 for Actinic Keratoses Treatment
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| light curettage | Procedure | — | UNRESOLVED |
| Pre irradiation of 1 hour | Other | — | UNRESOLVED |
| Pre irradiation of 3 hour | Other | — | UNRESOLVED |
| topical application of 16% methyl aminolevulinate photosensitizer (MAL) | Other | — | UNRESOLVED |
| topical application of 8% methyl aminolevulinate photosensitizer MAL | Other | — | UNRESOLVED |
| Visible light source | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- - Control Group (gold standard - 16% MAL with 3-hour incubation time)
- description
- 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).
- interventionNames
- Procedure: light curettage
- Other: Pre irradiation of 3 hour
- Other: topical application of 16% methyl aminolevulinate photosensitizer (MAL)
- Device: Visible light source
- type
- EXPERIMENTAL
- label
- Experimental Group (16% MAL incubation time - 1 hour)
- description
- 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).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available