TY - JOUR

T1 - Investigating the efficacy and safety of calcipotriol/betamethasone dipropionate foam and laser microporation for psoriatic nail disease—A hybrid trial using a smartphone application, optical coherence tomography, and patient-reported outcome measures

AU - Ortner, Vinzent Kevin

AU - Mandel, Victor Desmond

AU - Skak, Kresten

AU - Zibert, John Robert

AU - Bourlioux, Mélanie

AU - Nissen, Christoffer Valdemar

AU - Fuchs, Christine Sofie Krohn

AU - Philipsen, Peter Alshede

AU - Haedersdal, Merete

N1 - Funding Information: Merete Haedersdal has received research grants from Innovation Fund Denmark and LEO Pharma A/S. Publisher Copyright: © 2022 The Authors. Dermatologic Therapy published by Wiley Periodicals LLC.

PY - 2022

Y1 - 2022

N2 - There is a lack of efficacious topical treatments for patients suffering from psoriatic nail disease (PND). We investigated the efficacy of Calcipotriol-Betamethasone Dipropionate (Cal/BD) foam with and without ablative fractional laser (AFL) in patients with PND. A total of 144 nails from 11 patients were treated in a 24-week long, open-label, randomized, intra-patient controlled proof-of-concept hybrid trial. In addition to daily Cal/BD foam application, half of each patient's psoriatic nails were randomized to receive optical coherence tomography (OCT)-guided AFL treatment at baseline, 6-, and 12-week follow-ups. In-clinic assessment (N-NAIL), patient-reported outcomes (PROMs), and drug consumption were supplemented by remote evaluation of 15 subclinical OCT features, smartphone app-based safety monitoring, and photo-based assessment (NAPSI). After 24 weeks of Cal/BD foam treatment, patients achieved a significant improvement (p < 0.001) in both clinical (N-NAIL −76%, NAPSI −68%) and subclinical (OCT −43%) PND severity as well as a 71% reduction in PROMs. AFL-assisted Cal/BD treatment led to higher clinical (N-NAIL −85%, NAPSI −78%) and OCT-assessed (−46%) reduction of PND signs than Cal/BD alone (N-NAIL −66%, NAPSI −58%, OCT −37%), but did not reach statistical significance. Smartphone app images documented adverse events and mild local skin reactions, particularly erythema (75%), laser-induced swelling (28%), and crusting (27%). This hybrid trial demonstrated a reduction in clinical NAPSI and N-NAIL scores, subclinical OCT features, and PROMs, suggesting that Cal/BD foam is a safe and efficacious treatment for PND. Larger trials are warranted to prove the clinical benefit of AFL pretreatment as a Cal/BD delivery enhancer.

AB - There is a lack of efficacious topical treatments for patients suffering from psoriatic nail disease (PND). We investigated the efficacy of Calcipotriol-Betamethasone Dipropionate (Cal/BD) foam with and without ablative fractional laser (AFL) in patients with PND. A total of 144 nails from 11 patients were treated in a 24-week long, open-label, randomized, intra-patient controlled proof-of-concept hybrid trial. In addition to daily Cal/BD foam application, half of each patient's psoriatic nails were randomized to receive optical coherence tomography (OCT)-guided AFL treatment at baseline, 6-, and 12-week follow-ups. In-clinic assessment (N-NAIL), patient-reported outcomes (PROMs), and drug consumption were supplemented by remote evaluation of 15 subclinical OCT features, smartphone app-based safety monitoring, and photo-based assessment (NAPSI). After 24 weeks of Cal/BD foam treatment, patients achieved a significant improvement (p < 0.001) in both clinical (N-NAIL −76%, NAPSI −68%) and subclinical (OCT −43%) PND severity as well as a 71% reduction in PROMs. AFL-assisted Cal/BD treatment led to higher clinical (N-NAIL −85%, NAPSI −78%) and OCT-assessed (−46%) reduction of PND signs than Cal/BD alone (N-NAIL −66%, NAPSI −58%, OCT −37%), but did not reach statistical significance. Smartphone app images documented adverse events and mild local skin reactions, particularly erythema (75%), laser-induced swelling (28%), and crusting (27%). This hybrid trial demonstrated a reduction in clinical NAPSI and N-NAIL scores, subclinical OCT features, and PROMs, suggesting that Cal/BD foam is a safe and efficacious treatment for PND. Larger trials are warranted to prove the clinical benefit of AFL pretreatment as a Cal/BD delivery enhancer.

KW - drug delivery

KW - imaging

KW - nail disease

KW - psoriasis

KW - smartphone

KW - topical

U2 - 10.1111/dth.15965

DO - 10.1111/dth.15965

M3 - Journal article

C2 - 36321647

AN - SCOPUS:85142635487

VL - 35

JO - Dermatologic Therapy

JF - Dermatologic Therapy

SN - 1396-0296

IS - 12

M1 - e15965

ER -