Evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp.
PMID:
Photodiagnosis Photodyn Ther. 2022 Mar ;37:102623. Epub 2021 Nov 11. PMID: 34775065
Abstract Title:
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols.
Abstract:
BACKGROUND: Pain is a frequent adverse event during photodynamic therapy, which can limit treatment acceptance. This study aimed to evaluate the efficacy and pain during photodynamic therapy with two irradiation protocols in patients with actinic keratosis on the face and scalp.METHODS: In this intra-patient randomized controlled trial, participants were randomly allocated to receive photodynamic therapy with methyl aminolevulinate and red light on the right or left side with protocol 1 (irradiation device in contact with the skin) and protocol 2 (device 3 cm away from the skin). There was a 15-day interval between the protocols. The primary outcome was the frequency of mean intensity of moderate or severe pain during photodynamic therapy. Secondary outcomes were actinic keratosis clearance rate, protoporphyrin IX consumption, participant preference, skin appearance, and adverse events.RESULTS: Forty-one participants were included, yielding 47 and 50 randomized sites for protocols 1 and 2. There was no difference in the frequency of moderate and severe pain, with a relative risk of 1.09 (95% CI 0.70-1.70), p>0.05. An actinic keratosis count reduction>60% was observed in both protocols (p
