Photodynamic therapy is more effective than imiquimod for actinic keratosis in organ transplant recipients – a randomized intra-individual controlled trial

Abstract

Background

Actinic keratoses (AKs) in solid organ transplant recipients (OTRs) are difficult-to-treat pre-malignancies and comparison of topical therapies is therefore warranted.

Objectives

In an intra-individual study to compare efficacy and safety of field treatment with methyl aminolevulinate photodynamic therapy (MAL-PDT) and imiquimod (IMIQ) for AKs in OTRs.

Materials and methods

OTRs (n=35) with 572 AKs (grade I-III) in two similar areas in the face, scalp, dorsal hands or forearms were included. All patients received one MAL-PDT and one IMIQ session (3 weekly applications for 4 weeks) in each study area according to randomization. Treatments were repeated after 2 months (IMIQ) and 3 months (PDT) in skin with incomplete AK-response. Outcome measures were complete lesion response (CR), skin reactions, laboratory results and treatment preference.

Results

The majority of study areas received two treatment sessions (PDT n=25, IMIQ n=29 patients). At 3 months after two treatments, PDT-treated skin achieved higher CR (AK I-III, median 78%, range 50-100%) compared to IMIQ-treated skin areas (median 61%, range 33-100%, p <0.001). Fewer emergent AKs were seen in PDT- vs. IMIQ-treated skin (0.7 vs. 1.5 AK, p=0.04). Patients developed more intense inflammatory skin reactions following PDT (PDT 2.8, IMIQ 1.7, p<0.01) that resolved faster compared to IMIQ (median 10 vs. 18 days, p<0.01). Patient preference (p= 0.47) and cosmesis (p>0.30) were similar for PDT and IMIQ. No significant changes in laboratory results were observed.

Conclusion

Compared to IMIQ, PDT-treatment obtained higher AK clearance at 3-month follow-up and shorter-lasting, but more intense short-term skin reactions.

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