CompletedNot Applicable

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

Brazil4 participantsStarted 2024-11-30

Plain-language 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.

Who can participate

Age range

40 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete remission baseline

Timeframe: baseline

Complete remission -30 days

Timeframe: 30 days

Complete remission - 3 months

Timeframe: 3 months

Complete remission - 6 months

Timeframe: 6 months

Trial details

NCT IDNCT06507644

SponsorUniversity of Nove de Julho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More Actinic Keratoses trials