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Efficacy and tolerability of an investigational nitric oxide–releasing topical gel in patients with molluscum contagiosum: A randomized clinical trial - 13/03/20

Doi : 10.1016/j.jaad.2019.09.064 
Adelaide A. Hebert, MD a, Elaine C. Siegfried, MD b, Todd Durham, PhD, MS c, , Emily N. de León, MSCR c, Teresa Reams, AB c, Elizabeth Messersmith, PhD c, Tomoko Maeda-Chubachi, MD, PhD, MBA c,
a UTHealth McGovern Medical School, Houston, Texas 
b Saint Louis University School of Medicine, St Louis, Missouri 
c Novan, Inc, Morrisville, North Carolina 

Correspondence to: Tomoko Maeda-Chubachi, MD, PhD, MBA, Novan, Inc, 4105 Hopson Rd, Morrisville, NC 27560.Novan, Inc4105 Hopson RdMorrisvilleNC27560

Abstract

Background

Although a variety of ablative, topical, and systemic therapies are used for molluscum contagiosum (MC), none has been well studied or approved by the US Food and Drug Administration.

Objectives

To compare the efficacy and tolerability of topical SB206 (berdazimer sodium gel coadministered with hydrogel) with vehicle.

Methods

A 12-week, phase 2, multicenter, randomized, double-blind, vehicle-controlled clinical trial of topical SB206.

Results

A total of 256 patients (mean age, approximately 7 years) participated. Of patients who completed 12 weeks of treatment (n = 217), all MC lesions cleared in 20.0% of patients who received vehicle compared with 13.2%, 41.0%, and 35.1% of patients treated with twice daily SB206 4%, 8%, and 12%, respectively, and 41.9% of patients treated with once daily SB206 12%. Application-site erythema occurred in 10.6% of patients treated with SB206. Application-site reactions were the most common adverse events leading to treatment discontinuation, affecting 2 patients (approximately 4%) in each of the SB206 4%, 8%, and 12% twice daily groups and 0 patients in the vehicle or SB206 12% once daily groups.

Limitations

A larger study is needed to confirm the efficacy of SB206 12% once daily and provide additional safety assessments.

Conclusion

Of the doses studied, SB206 12% applied once daily provided the best balance between MC lesion clearance and tolerability for evaluation in a larger study.

Le texte complet de cet article est disponible en PDF.

Graphical abstract




Le texte complet de cet article est disponible en PDF.

Key words : communicable diseases, dermatology, molluscum contagiosum, nitric oxide, topical administration

Abbreviations used : AD, AE, BOTE, CI, ITT, LS, MC, mITT, MMRM, NO


Plan


 Funding sources: Supported by Novan, Inc.
 Disclosure: Dr Hebert has conducted research for Novan, Valeant, Cutanea, Cassiopea, Galderma, Allergan, Demira, Medimetriks, Mayne, Promius, Amgen, Leo Pharma, GSK, Sienna, Celgene, Brickell and Pfizer (all research funding has been paid to the UTHealth McGovern Medical School-Houston, TX); has served on advisory boards for Ortho, Verrica, Cutanea, Pierre Fabre, Novan, and Dermavant Sciences; has served on data safety monitoring boards for Sanofi Regeneron and GSK; and has received honoraria for lectures from Pfizer, Demira, Valeant, Amgen, Cutanea, and Leo Pharma. Dr Siegfried has served as a consultant for Dermavant Sciences, GlaxoSmithKline, LEO Pharma, Novan, Inc, Pierre Fabre Dermo-Cosmétique US, Pfizer Inc, Regeneron, Sanofi, UCB, Valeant Pharmaceuticals, and Verrica Pharmaceuticals Inc; has been a principal investigator for Eli Lilly, Janssen Pharmaceuticals, Inc, Regeneron, and Verrica Pharmaceuticals Inc; has been a data safety monitoring board member for LEO Pharma and Novan, Inc; and has been an advisory board member for Verrica Pharmaceuticals Inc. Ms de León, Ms Reams, Dr Messersmith and Dr Maeda-Chubachi are employees and stockholders in Novan, Inc. Dr Durham was an employee and stockholder in Novan, Inc, when the study and analysis were completed.
 IRB approval status: Reviewed and approved by Sterling IRB (00001790).
 Reprints not available from the authors.


© 2019  American Academy of Dermatology, Inc. Tous droits réservés.
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Vol 82 - N° 4

P. 887-894 - avril 2020 Retour au numéro
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