COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy and Safety and the Optimal Regimen of VP-102, a Proprietary Drug-Device Product Containing Topical Cantharidin (0.7% w/v) Under Occlusion for the Treatment of Common Warts.
Cantharidin
Common warts
Lesion
Phase 2 clinical trial
Topical treatment
VP-102
Verruca
Verruca vulgaris
Verrucae
Warts
Journal
Dermatology and therapy
ISSN: 2193-8210
Titre abrégé: Dermatol Ther (Heidelb)
Pays: Switzerland
ID NLM: 101590450
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
received:
21
04
2021
accepted:
01
07
2021
pubmed:
22
7
2021
medline:
22
7
2021
entrez:
21
7
2021
Statut:
ppublish
Résumé
Verrucae vulgaris, or common warts, is a common skin condition for which there is no US Food and Drug Administration-approved treatment. Compounded cantharidin has been used to treat warts for years but lacks a controlled formulation, consistent application schedule and methods, and robust safety and efficacy studies. VP-102 is a proprietary drug-device combination product containing a topical formulation of 0.7% (w/v) cantharidin in a single-use delivery device. This objective of the phase 2 study was to evaluate the efficacy, safety, tolerability, and optimal regimen of VP-102 in the treatment of common warts. In this open-label trial, participants aged ≥ 2 years with one to six common warts were administered VP-102 topically to treatable common warts once every 14 days (Cohort 1) or once every 21 days in conjunction with paring (Cohort 2), for up to four treatments. Participants were evaluated through to day 84 (Cohort 1) or day 147 (Cohort 2). The primary endpoint was the percentage of participants with complete clearance of all treatable common warts (baseline and new) at day 84. Secondary endpoints included percentage of participants achieving complete clearance of all treatable common warts at other visits. Safety assessments included treatment-emergent adverse events (TEAEs), including local skin reactions (LSRs). A total of 21 and 35 participants were enrolled in Cohort 1 and Cohort 2, respectively. Complete clearance at day 84 was seen in 19.0% of participants in Cohort 1 and 51.4% of those in Cohort 2. The most common TEAEs were expected LSRs and included application site vesicles, pain, pruritus, erythema, and scab. Most LSRs were mild or moderate in severity. VP-102 showed efficacy in complete clearance of common warts from baseline to day 84, as well as at follow-up visits. Due to the higher percentage of patients exhibiting complete clearance in Cohort 2, the treatment regimen of Cohort 2 will be pursued in future studies. TEAEs were expected due to the pharmacodynamic action of cantharidin, a vesicant. Clinical Trials ID: NCT03487549.
Identifiants
pubmed: 34286459
doi: 10.1007/s13555-021-00576-y
pii: 10.1007/s13555-021-00576-y
pmc: PMC8484407
doi:
Banques de données
ClinicalTrials.gov
['NCT03487549']
Types de publication
Journal Article
Langues
eng
Pagination
1623-1634Informations de copyright
© 2021. The Author(s).
Références
Clifton MM, Johnson SM, Roberson PK, Kincannon J, Horn TD. Immunotherapy for recalcitrant warts in children using intralesional mumps or Candida antigens. Pediatr Dermatol. 2003;20(3):268–71.
doi: 10.1046/j.1525-1470.2003.20318.x
Stulberg DL, Hutchinson AG. Molluscum contagiosum and warts. Am Fam Physician. 2003;67(6):1233–40.
pubmed: 12674451
Ciconte A, Campbell J, Tabrizi S, Garland S, Marks R. Warts are not merely blemishes on the skin: a study on the morbidity associated with having viral cutaneous warts. Australas J Dermatol. 2003;44(3):169–73.
doi: 10.1046/j.1440-0960.2003.00672.x
Sterling JC, Handfield-Jones S, Hudson PM, British Association of Dermatology. Guidelines for the management of cutaneous warts. Br J Dermatol. 2001;144(1):4–11.
doi: 10.1046/j.1365-2133.2001.04066.x
Kwok CS, Gibbs S, Bennett C, Holland R, Abbott R. Topical treatments for cutaneous warts. Cochrane Database Syst Rev. 2012;9:CD001781.
Kwok CS, Holland R, Gibbs S. Efficacy of topical treatments for cutaneous warts: a meta-analysis and pooled analysis of randomized controlled trials. Br J Dermatol. 2011;165(2):233–46.
doi: 10.1111/j.1365-2133.2011.10218.x
Epstein WL, Kligman AM. Treatment of warts with cantharidin. AMA Arch Derm. 1958;77(5):508–11.
doi: 10.1001/archderm.1958.01560050014003
Day R, Harbord M, Forbes A, Segal A. Cantharidin blisters: a technique for investigating leukocyte trafficking and cytokine production at sites of inflammation in humans. J Immunol Methods. 2001;257:213–20.
doi: 10.1016/S0022-1759(01)00467-7
Del Rosso JQ, Kircik L. Topical cantharidin in the management of molluscum contagiosum: preliminary assessment of an ether-free, pharmaceutical-grade formulation. J Clin Aesthet Dermatol. 2019;12(2):27–30.
pubmed: 30881580
pmcid: 6415708
Panzer HM. Cantharidin—a useful agent in the local treatment of warts. J Germantown Hosp. 1961;2:82–6.
pubmed: 14483618
Rosenberg EW, Amonette RA, Gardner JH. Cantharidin treatment of warts at home. Arch Dermatol. 1977;113(8):1134.
doi: 10.1001/archderm.1977.01640080136040
Epstein JH, Epstein WL. Cantharidin treatment of digital and periungual warts. Calif Med. 1960;93:11–2.
pubmed: 13820498
pmcid: 1578244
Kartal Durmazlar SP, Atacan D, Eskioglu F. Cantharidin treatment for recalcitrant facial flat warts: a preliminary study. J Dermatol Treat. 2009;20:114–9.
doi: 10.1080/09546630802287546
Bock RH. Treatment of palpebral warts with cantharon. Am J Ophthalmol. 1965;60(3):529–30.
doi: 10.1016/0002-9394(65)90724-5
Becerro de Bengoa Vallejo R, Losa Iglesias ME, Gómez-Martín B, Sánchez Gómez R, Sáez CA. Application of cantharidin and podophyllotoxin for the treatment of plantar warts. J Am Podiatr Med Assoc. 2008;98(6):445–50.
doi: 10.7547/0980445
Coskey RJ. Treatment of plantar warts in children with a salicylic acid-podophyllin-cantharidin product. Pediatr Dermatol. 1984;2(1):71–3.
doi: 10.1111/j.1525-1470.1984.tb00446.x
Ghonemy S. Treatment of recalcitrant plantar warts with long-pulsed Nd:YAG laser versus cantharidin-podophylline resin-salicylic acid. J Cosmet Laser Therapy. 2017;19(6):347–52.
doi: 10.1080/14764172.2017.1326608
Kaçar N, Taşlı L, Korkmaz S, Ergin S, Erdoğan B. Cantharidin-podophylotoxin-salicylic acid versus cryotherapy in the treatment of plantar warts: a randomized prospective study. J Eur Acad Dermatol Venereol. 2012;26(7):889–93.
doi: 10.1111/j.1468-3083.2011.04186.x
López-López D, Agrasar-Cruz C, Bautista-Casasnovas A, Álvarez-Castro CJ. Application of cantharidin, podophyllotoxin, and salicylic acid in recalcitrant plantar warts. A preliminary study. Gac Med Mex. 2015;151(1):14–9.
pubmed: 25739479
Sterling JC, Gibbs S, Haque Hussain SS, Mohd Mustapa MF, Handfield-Jones SE. British Association of Dermatologists’ guidelines for the management of cutaneous warts 2014. Br J Dermatol. 2014;171(4):696–712.
doi: 10.1111/bjd.13310
Eichenfield LF, McFalda W, Brabec B, et al. Safety and efficacy of VP-102, a proprietary drug-device combination product containing cantharidin, 0.7% (w/v), in children and adults with molluscum contagiosum: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156(12):1315–23.
doi: 10.1001/jamadermatol.2020.3238
Eichenfield LF, Siegfried E, Kwong P, et al. Pooled results of two randomized phase III trials evaluating VP-102, a drug-device combination product containing cantharidin 0.7% (w/v) for the treatment of molluscum contagiosum. Am J Clin Dermatol. 2021;22:257–65. https://doi.org/10.1007/s40257-020-00570-8 .
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–4.
doi: 10.1001/jama.2013.281053
Leman JA, Benton EC. Verrucas. Guidelines for management. Am J Clin Dermatol. 2000;1(3):143–9.
doi: 10.2165/00128071-200001030-00001