A double-blind, randomized controlled trial to compare the effectiveness and safety of purified protein derivative of tuberculin antigen with Mycobacterium w vaccine in the treatment of multiple viral warts

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dc.contributor.authorChandra, Somodyutien_US
dc.contributor.authorSil, Amritaen_US
dc.contributor.authorDatta, Adrijaen_US
dc.contributor.authorPal, Santasmitaen_US
dc.contributor.authorDas, Nilay Kantien_US
dc.date.accessioned2020-01-02T06:52:38Z
dc.date.available2020-01-02T06:52:38Z
dc.date.issued2019-07
dc.description.abstractBackground: Present day therapeutic modalities for viral warts are mostly ablative in nature, limited by high recurrence rates and are unsuitable for numerous lesions. Immunotherapy has the potential to overcome these limitations. Aims: This study aimed at comparing efficacy and safety of and quality of life changes with intradermal purified protein derivative (PPD) of tuberculin antigen and Mycobacterium w (Mw) vaccine in immunotherapy of warts. Methods: Patients with multiple (≥5) warts were randomized (1:1) into two groups (PPDand, Mw vaccine groups). Fortnightly, 0.1 ml of either medicine was injected intradermally over the deltoidregion till complete resolution or a maximum of six doses. Patients were followed-up for another 3 months for recurrence. Results: Sixty-four participants received either PPD or Mw vaccine. The number of warts were comparable at baseline (P = 0.089, Mann–Whitney test), and reduced significantly with treatment in both groups (P < 0.001, Friedman's ANOVA), as seen from the fourth follow-up onwards with Mw and fifth follow-up onwards with PPD (P < 0.05, Post hoc Dunn's test). Intergroup comparison showed significantly more (P < 0.05, Mann–Whitney test) reduction with Mw than PPD at the sixth and seventh follow-up. The size of warts also reduced significantly (P < 0.001) in both groups from the third follow-up onwards. Complete remission was more (P = 0.539, Fischer's exact test) in the Mw group (68.8%) than the PPD group (50%); and was significantly higher (P = 0.049, Mann–Whitney test) in patients having shorter duration of warts. Adverse events were significantly more (P < 0.001) with Mw including ulceration (50%), discharge (15.6%), pain-swelling-induration and scar at the injection site (97% each), whereas some of those receiving PPD noted erythema and scaling at the injection site (18.8%), and post-inflammatory hyperpigmentation (12.5%). No recurrence was seen till the end of the study. Limitation: Unicentric trial. Conclusion: Intradermal injection of Mw vaccine was more effective but had a higher incidence of adverse effects compared to PPD of tuberculin antigen in patients with warts.en_US
dc.identifier.affiliationsDepartment of Dermatology, Medical College and Hospital, Kolkata, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmacology, Rampurhat Government Medical College, Rampurhat, West Bengal, Indiaen_US
dc.identifier.affiliationsDepartment of Biochemistry, Medical College and Hospital, Kolkata, Indiaen_US
dc.identifier.affiliationsDepartment of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, Indiaen_US
dc.identifier.citationChandra Somodyuti, Sil Amrita, Datta Adrija, Pal Santasmita, Das Nilay Kanti. A double-blind, randomized controlled trial to compare the effectiveness and safety of purified protein derivative of tuberculin antigen with Mycobacterium w vaccine in the treatment of multiple viral warts. Indian Journal of Dermatology, Venereology and Leprology. 2019 Jul; 85(4): 355-366en_US
dc.identifier.issn0378-6323
dc.identifier.issn0973-3922
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/192502
dc.languageenen_US
dc.publisherIndian Association of Dermatologists, Venereologists & Leprologistsen_US
dc.relation.issuenumber4en_US
dc.relation.volume85en_US
dc.source.urihttps://dx.doi.org/10.4103/ijdvl.IJDVL_549_18en_US
dc.subjectImmunotherapyen_US
dc.subjectMycobacterium w vaccineen_US
dc.subjectpurified protein derivativeen_US
dc.subjectrandomized controlled trialen_US
dc.subjectviral wartsen_US
dc.titleA double-blind, randomized controlled trial to compare the effectiveness and safety of purified protein derivative of tuberculin antigen with Mycobacterium w vaccine in the treatment of multiple viral wartsen_US
dc.typeJournal Articleen_US
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