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
Research output: Contribution to journal › Journal article › Research › peer-review
Documents
- Fulltext
Final published version, 2.93 MB, PDF document
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.
Original language | English |
---|---|
Article number | e15965 |
Journal | Dermatologic Therapy |
Volume | 35 |
Issue number | 12 |
ISSN | 1396-0296 |
DOIs | |
Publication status | Published - 2022 |
Bibliographical note
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.
- drug delivery, imaging, nail disease, psoriasis, smartphone, topical
Research areas
ID: 334008026