ORIGINAL ARTICLE   Free access

Italian Journal of Dermatology and Venereology 2022 April;157(2):164-72

DOI: 10.23736/S2784-8671.21.07111-5

Copyright © 2021 EDIZIONI MINERVA MEDICA

lingua: Inglese

Treatment adherence with diclofenac 3% gel among patients with multiple actinic keratoses: an integrated low-intensity intervention program versus standard-of-care

Francesca PERINO ^{1, 2}, Alice FATTORI ³, Alfredo PICCERILLO ^{1, 2}, Luca BIANCHI ⁴, Maria C. FARGNOLI ⁵, Pasquale FRASCIONE ⁶, Giovanni PELLACANI ⁷, Anna CARBONE ⁶, Elena CAMPIONE ⁴, Maria ESPOSITO ⁵, Maria T. ROSSI ⁸, Alice CASARI ⁹, Piergiacomo CALZAVARA-PINTON ⁸, Ketty PERIS ^{1, 2} ✉

¹ Unit of Dermatology, Sacred Heart Catholic University, Rome, Italy; ² IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy; ³ Unit of Occupational Health, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy; ⁴ Unit of Dermatology, Policlinico Tor Vergata, Tor Vergata University, Rome, Italy; ⁵ Unit of Dermatology, Department of Biotechnological and Clinical Sciences, University of L’Aquila, L’Aquila, Italy; ⁶ Unit of Dermatologic Oncology, IRCCS San Gallicano Dermatological Institute, Rome, Italy; ⁷ Unit of Dermatology, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy; ⁸ Department of Dermatology, University of Brescia, Brescia, Italy; ⁹ Unit of Dermatology, University Hospital Polyclinic of Modena, Modena, Italy

BACKGROUND: Diclofenac 3% gel is a widely used topical treatment with proven efficacy in reducing the burden of actinic keratosis (AK); however, clinical benefit might not fully translate in clinical practice as nonadherence is substantial for prolonged treatment regimens. We evaluated the efficacy of an integrated low-intensity intervention program versus standard-of-care on treatment adherence among patients with multiple AK receiving diclofenac in hyaluronic acid gel 3%.
METHODS: We designed an open label, randomized, parallel group, interventional, multicenter, longitudinal cohort study including patients with multiple, grade I/II AKs. Visits were scheduled for end of treatment (T4), follow-up 1 (T5) and follow-up 2 (T6) at 90, 180 and 365 days from baseline, respectively. Patients in the intervention group received additional visits at 30 and 60 days from baseline, a brief health education intervention, an enhanced patient-physician communication, a weekly SMS reminder to medication prescriptions.
RESULTS: Patients were equally allocated between intervention (intervention group [IG], N.=86) and control group ([CG] N.=86); at baseline, both groups had similar socio-demographic and clinical characteristics. Change scores from baseline showed a slight increment in quality of life related to AK in both groups (CG: ΔT4-T1=-0.079; IG: ΔT4-T1=-0.006; P=0.39) and in quality of physician-patient interaction reported by IG (ΔT3-T2=0.18; P<0.0001). Adherence rate was not statistically different between IG and CG (28.4% vs. 40.7%; P=0.11). Patients reported similar satisfaction for effectiveness, convenience and side effects of treatment. Clinical conditions improved over time and results did not differ between groups; complete clearance rate at 1 year was 18% and 29% for CG and IG, respectively.
CONCLUSIONS: Our findings showed no difference in adherence rate between the two groups, suggesting that enhanced follow-up interventions and health care education may not be sufficient drivers to promote adherence among this clinical population. Further studies are needed to explore barriers to adherence with treatments for AKs.

KEY WORDS: Keratosis, actinic; Diclofenac; Dermatology