Human papillomavirus infection: protocol for a randomised controlled trial of imiquimod cream (5%) versus podophyllotoxin cream (0.15%), in combination with quadrivalent human papillomavirus or control vaccination in the treatment and prevention of recurrence of anogenital warts (HIPvac trial)

doi:10.1186/s12874-018-0581-z

Randomized Controlled Trial

. 2018 Nov 6;18(1):125.

doi: 10.1186/s12874-018-0581-z.

Human papillomavirus infection: protocol for a randomised controlled trial of imiquimod cream (5%) versus podophyllotoxin cream (0.15%), in combination with quadrivalent human papillomavirus or control vaccination in the treatment and prevention of recurrence of anogenital warts (HIPvac trial)

Affiliations

¹ Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, Gower Street, London, WC1E 6BT, UK.
² UCL Centre for Clinical Research in Infection and Sexual Health, The Mortimer Market Centre, Institute for Global Health, University College London, London, WC1E 6JB, UK.
³ Centre for Immunology and Infection, Hull York Medical School, University of York, York, YO10 5DD, UK.
⁴ Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
⁵ Public Health England, London, NW9 5EQ, UK.
⁶ Homerton Anal Neoplasia Service, Homerton University Hospital NHS Foundation Trust, London, E9 6SR, UK.
⁷ UCL Centre for Clinical Research in Infection and Sexual Health, The Mortimer Market Centre, Institute for Global Health, University College London, London, WC1E 6JB, UK. r.gilson@ucl.ac.uk.

PMID: 30400777
PMCID: PMC6220496
DOI: 10.1186/s12874-018-0581-z

Randomized Controlled Trial

Human papillomavirus infection: protocol for a randomised controlled trial of imiquimod cream (5%) versus podophyllotoxin cream (0.15%), in combination with quadrivalent human papillomavirus or control vaccination in the treatment and prevention of recurrence of anogenital warts (HIPvac trial)

Macey L Murray et al. BMC Med Res Methodol. 2018.

. 2018 Nov 6;18(1):125.

doi: 10.1186/s12874-018-0581-z.

Authors

Affiliations

¹ Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, Gower Street, London, WC1E 6BT, UK.
² UCL Centre for Clinical Research in Infection and Sexual Health, The Mortimer Market Centre, Institute for Global Health, University College London, London, WC1E 6JB, UK.
³ Centre for Immunology and Infection, Hull York Medical School, University of York, York, YO10 5DD, UK.
⁴ Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
⁵ Public Health England, London, NW9 5EQ, UK.
⁶ Homerton Anal Neoplasia Service, Homerton University Hospital NHS Foundation Trust, London, E9 6SR, UK.
⁷ UCL Centre for Clinical Research in Infection and Sexual Health, The Mortimer Market Centre, Institute for Global Health, University College London, London, WC1E 6JB, UK. r.gilson@ucl.ac.uk.

PMID: 30400777
PMCID: PMC6220496
DOI: 10.1186/s12874-018-0581-z

Abstract

Background: Anogenital warts are the second most common sexually transmitted infection diagnosed in sexual health services in England. About 90% of genital warts are caused by human papillomavirus (HPV) types 6 or 11, and half of episodes diagnosed are recurrences. The best and most cost-effective treatment for patients with anogenital warts is unknown. The commonly used treatments are self-administered topical agents, podophyllotoxin (0.15% cream) or imiquimod (5% cream), or cryotherapy with liquid nitrogen. Quadrivalent HPV (qHPV) vaccination is effective in preventing infection, and disease, but whether it has any therapeutic effect is not known.

Methods and design: To investigate the efficacy of clearance and prevention of recurrence of external anogenital warts by topical treatments, podophyllotoxin 0.15% cream or imiquimod 5% cream, in combination with a three-dose regimen of qHPV or control vaccination. 500 adult patients presenting with external anogenital warts with either a first or subsequent episode of anogenital warts will be entered into this randomised, controlled partially blinded 2 × 2 factorial trial.

Discussion: The trial is expected to provide the first high-quality evidence of the comparative efficacy and cost-effectiveness of the two topical treatments in current use, as well as investigate the potential benefit of HPV vaccination, in the management of anogenital warts.

Trial registration: The trial was registered prior to starting recruitment under the following reference numbers: International Standard Randomized Controlled Trial Number (ISRCTN) Registry - ISRCTN32729817 (registered 25 July 2014); European Union Clinical Trials Register (EudraCT) - 2013-002951-14 (registered 26 June 2013).

Keywords: Anogenital warts; Human papillomavirus; Imiquimod; Podophyllotoxin; Quadrivalent HPV vaccine.

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Conflict of interest statement

Ethics approval and consent to participate

The trial protocol was reviewed by the Oxfordshire Research Ethics Committee B (reference 13/SC/0638). Written informed consent is sought from each participant prior to enrolment.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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References

1. Public Health England. Sexually transmitted infections (STIs): annual data tables. Table 1: STI diagnoses and rates in England by gender, 2008 to 2017. https://www.gov.uk/government/statistics/sexually-transmitted-infections.... Accessed 14 Dec 2017.
1. Desai S, Wetten S, Woodhall SC, Peters L, Hughes G, Soldan K. Genital warts and cost of care in England. Sex Transm Infect. 2011;87:464–468. doi: 10.1136/sti.2010.048421. - DOI - PMC - PubMed
1. Edwards A, Atma-Ram A, Thin RN. Podophyllotoxin 0.5% v podophyllin 20% to treat penile warts. Genitourin Med. 1988;64(4):263–265. - PMC - PubMed
1. Beutner KR, Conant MA, Friedman-Kien AE, Illeman M, Artman NN, Thisted RA, et al. Patient-applied podofilox for treatment of genital warts. Lancet. 1989;1(8642):831–834. doi: 10.1016/S0140-6736(89)92282-4. - DOI - PubMed
1. Mazurkiewicz WJS. Clinical efficacy of Condyline (0.5% podophyllotoxin) solution and cream versus podophyllin in the treatment of external condylomata acuminata. J Dermatolog Treat. 1990;1(3):123–125. doi: 10.3109/09546639009086712. - DOI

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[1] Public Health England. Sexually transmitted infections (STIs): annual data tables. Table 1: STI diagnoses and rates in England by gender, 2008 to 2017. https://www.gov.uk/government/statistics/sexually-transmitted-infections.... Accessed 14 Dec 2017.

[2] Public Health England. Sexually transmitted infections (STIs): annual data tables. Table 1: STI diagnoses and rates in England by gender, 2008 to 2017. https://www.gov.uk/government/statistics/sexually-transmitted-infections.... Accessed 14 Dec 2017.

[3] Desai S, Wetten S, Woodhall SC, Peters L, Hughes G, Soldan K. Genital warts and cost of care in England. Sex Transm Infect. 2011;87:464–468. doi: 10.1136/sti.2010.048421. - DOI - PMC - PubMed

[4] Desai S, Wetten S, Woodhall SC, Peters L, Hughes G, Soldan K. Genital warts and cost of care in England. Sex Transm Infect. 2011;87:464–468. doi: 10.1136/sti.2010.048421. - DOI - PMC - PubMed

[5] Edwards A, Atma-Ram A, Thin RN. Podophyllotoxin 0.5% v podophyllin 20% to treat penile warts. Genitourin Med. 1988;64(4):263–265. - PMC - PubMed

[6] Edwards A, Atma-Ram A, Thin RN. Podophyllotoxin 0.5% v podophyllin 20% to treat penile warts. Genitourin Med. 1988;64(4):263–265. - PMC - PubMed

[7] Beutner KR, Conant MA, Friedman-Kien AE, Illeman M, Artman NN, Thisted RA, et al. Patient-applied podofilox for treatment of genital warts. Lancet. 1989;1(8642):831–834. doi: 10.1016/S0140-6736(89)92282-4. - DOI - PubMed

[8] Beutner KR, Conant MA, Friedman-Kien AE, Illeman M, Artman NN, Thisted RA, et al. Patient-applied podofilox for treatment of genital warts. Lancet. 1989;1(8642):831–834. doi: 10.1016/S0140-6736(89)92282-4. - DOI - PubMed

[9] Mazurkiewicz WJS. Clinical efficacy of Condyline (0.5% podophyllotoxin) solution and cream versus podophyllin in the treatment of external condylomata acuminata. J Dermatolog Treat. 1990;1(3):123–125. doi: 10.3109/09546639009086712. - DOI

[10] Mazurkiewicz WJS. Clinical efficacy of Condyline (0.5% podophyllotoxin) solution and cream versus podophyllin in the treatment of external condylomata acuminata. J Dermatolog Treat. 1990;1(3):123–125. doi: 10.3109/09546639009086712. - DOI

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Human papillomavirus infection: protocol for a randomised controlled trial of imiquimod cream (5%) versus podophyllotoxin cream (0.15%), in combination with quadrivalent human papillomavirus or control vaccination in the treatment and prevention of recurrence of anogenital warts (HIPvac trial)

Affiliations

Human papillomavirus infection: protocol for a randomised controlled trial of imiquimod cream (5%) versus podophyllotoxin cream (0.15%), in combination with quadrivalent human papillomavirus or control vaccination in the treatment and prevention of recurrence of anogenital warts (HIPvac trial)

Authors

Affiliations

Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

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References

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Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Similar articles

Cited by

References

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Substances

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Related information

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