Status:
NOT_YET_RECRUITING
Methyl Aminolevulinate 8% and 16% Incubated by 1 and 3 for Actinic Keratoses Treatment
Lead Sponsor:
University of Nove de Julho
Conditions:
Actinic Keratoses
Eligibility:
All Genders
40-90 years
Phase:
NA
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 incub...
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06507644
Start Date
November 30 2024
End Date
May 30 2026
Last Update
October 15 2024
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