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

Launched by UNIVERSITY OF NOVE DE JULHO · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for actinic keratoses, which are rough, scaly patches on the skin caused by sun damage. The researchers want to find out which is more effective: using a cream with two different concentrations of a substance called Methyl Aminolevulinate (MAL) at 8% or 16%, combined with red light therapy. They will also look at how different waiting times—1 hour or 3 hours—before using the light affect the treatment. Participants will be divided into four groups to compare these different approaches over a period of six months.

To be eligible for this trial, individuals must be between 40 and 90 years old, have at least five visible actinic keratoses on their face, and not have received any other treatments in the past six months. Participants will not be accepted if they have certain skin conditions, allergies, or other health issues. Throughout the study, the effectiveness of the treatment will be monitored, and participants can expect to have their skin checked at 30 days, 3 months, and 6 months after treatment. Additionally, their quality of life will be assessed to see how the treatment affects their daily living. This trial is not yet recruiting, but it aims to improve how we treat skin affected by sun damage.

Gender

ALL

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.