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Dear Editor,
We would like to answer the points made by Dr. Bertolotti and Dr. Derancourt in their letter to the editor regarding the paper “A Multicentre, randomised clinical trial to compare a topical Nitrizinc® complex solution versus cryotherapy for the treatment of anogenital warts,” by Pontini et al.
First of all, we thank the authors for their observations, which mainly reflect the difficulties in planning studies on the treatment of anogenital warts.
We will try to respond to each point that was raised:
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Nitrizinc complex solution was applied following the manufacturer’s instructions. It is true that certain practical skills are needed to obtain the best results; these are difficult to describe. The same can be said about the use of cryoprobe. The procedure described by Bertolotti is what is usually done; we decided on a shorter interval (10 instead of 14 days) for practical issues, although we understand that this can represent a bias in comparing randomized clinical trials (RCTs).
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Blinding is a serious issue in planning RCTs in the field of anogenital warts. The suggestions made are quite complicated to perform in practice. We tried to keep our trial as simple as possible and also to maintain the context of daily clinical practice. To collect objective results, we decided that the investigator who evaluated the severity and response to treatment should be blind to the treatment applied, thereby reducing potential bias in the interpretation of results. We decided to treat all the patients for ethical reasons, due to the risk of partner contamination. It is not always easy to take photographs of the genital areas, and it may be disturbing for some patients.
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The majority of recurrences are reported to occur within the first 3 months. Certainly a longer evaluation period of 6–12 months would be interesting; however, in our experience, the number of patients not coming back after 6–12 months following treatment could be very high, preventing the collection of strong enough data for accurate interpretation. We therefore decided to follow up the patients for a period of 3 months, which we believed would give good enough data.
Finally, we want to thank again Dr. Bertolotti and colleague for their observations, and we completely agree with their final statement.
Acknowledgements
The authors would like to thank the patients for their participation in this study and Dr Bertolotti and colleague for their observations.
Funding
The study was sponsored by the Interdisciplinary Society for Sexually transmitted Diseases (Società Interdisciplinare Malattie aTrasmissione Sessuale [SIMAST]) and the journal’s Rapid Service Fee was funded by ISDIN. No Rapid Service Fee was received by the journal for the publication of this letter.
Medical Writing Assistance
Jane Marshall, a professional freelance medical writer, assisted in editing the manuscript. This assistance was funded by ISDIN.
Authorship
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Disclosures
Paolo Pontini, Luca Mastorino, Valeria Gaspari, Corinne Granger, Stefano Ramoni, Sergio Delmonte, Valeria Evangelista and Marco Cusini have nothing to disclose.
Compliance with Ethics Guidelines
This article is based on previously conducted studies and does not contain any studies with human participants or animals performed by any of the authors.
Peer Review
Please note, contrary to the journal’s standard single-blind peer review process, as a letter this article underwent review by a member of the journal’s Editorial Board.
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Pontini, P., Mastorino, L., Gaspari, V. et al. Response to Letter to the Editor Regarding “A Multicentre, Randomised Clinical Trial to Compare a Topical Nitrizinc® Complex Solution Versus Cryotherapy for the Treatment of Anogenital Warts”. Dermatol Ther (Heidelb) 10, 1439–1440 (2020). https://doi.org/10.1007/s13555-020-00450-3
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DOI: https://doi.org/10.1007/s13555-020-00450-3