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, andpatient‐reportedoutcome measures

Abstract

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), patientreported 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 À76%, NAPSI À68%) and subclinical (OCT À43%) PND severity as well as a 71% reduction in PROMs. AFL-assisted Cal/BD treatment led to higher clinical (N-NAIL À85%, NAPSI À78%) and OCT-assessed (À46%) reduction of PND signs than Cal/BD alone (N-NAIL À66%, NAPSI À58%, OCT À37%), 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.

Mobile health technologies in an interventional hybrid study on actinic keratosis: Results from an early phase randomized controlled trial investigating the safety and efficacy of a cytosolic phospholipase A2 inhibitor gel in photodamaged skin

“…Supplemented by questionnaires on patient-reported side effects, we were able to ensure patient safety using remote assessments which supports the BYOD concept in contemporary clinical research. 34,47 Hybrid trials that incorporate the use of PSPs do recognize and report on the fluctuations in image quality, 48 which can be ameliorated by image quality assessment by dermatologists, as performed in our study, or by the integration of convolutional neural networks for image quality assessment. 49 Despite the many advantages of collecting PSPs, changes in ambient…”

Ablative CO₂-Assisted Laser for Topical Drug Delivery in Nail Psoriasis: A Systematic Review

“…The results of our systematic literature review support the role of fractional laser treatment in the management of psoriasis while using topical medications. A total of 7 RCTs have been identified to date, out of which 4 were conducted as intra-patient studies [2,[10][11][12][13][14][15]. Despite the use of different topical medications and varying laser parameters across the studies, all of them have demonstrated a certain degree of reduction in NAPSI (although varying among the different studies).…”

A focused review on laser- and energy-assisted drug delivery for nail disorders

“…LADD shows promise in nail psoriasis treatment, with less pain and greater penetrative ability than traditional treatments. The following studies further discuss the efficacy, safety, and benefits of using LADD in nail psoriasis treatment (Table 2 ) [ 22 , 23 ].…”

“…The following studies further discuss the efficacy, safety, and benefits of using LADD in nail psoriasis treatment (Table 2 ) [ 22 , 23 ].…”