RBR-8tkx2dp Liquid nitrogen versus trichloroacetic acid, or their combination, in the treatment of penile warts

Date of registration: 02/21/2022 ^(mm/dd/yyyy)
Last approval date : 02/21/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1274-6164

• Public title:

  en

  Liquid nitrogen versus trichloroacetic acid, or their combination, in the treatment of penile warts

  pt-br

  Nitrogênio líquido versus ácido tricloroacético, ou sua associação, no tratamento de verrugas do pênis.

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • Número do Parecer do CEP: 3.826.868
    Issuing authority: Comitê de Ética em Pesquisa da Faculdade de Medicina de Botucatu
  • Número do CAAE: 28324919.0.0000.5411
    Issuing authority: Plataforma Brasil

Sponsors

• Primary sponsor: Faculdade de Medicina de Botucatu (FMB Unesp)
• Secondary sponsor:
  • Institution: Faculdade de Medicina de Botucatu (FMB Unesp)
• Supporting source:
  • Institution: Fundação de Amparo à Pesquisa do Estado de São Paulo - FAPESP

Health conditions

• Health conditions:

  en

  Condylomata Acuminata; Papillomavirus Infections

  pt-br

  Verruga genital; Infecção por papilomavírus

• General descriptors for health conditions:

  en

  35997 Papillomavirus Infections

  pt-br

  35997 Infecção por papilomavírus

• Specific descriptors:

  en

  24015 Condylomata Acuminata

  pt-br

  24015 Condiloma Acuminado

Interventions

• Interventions:

  en

  After being randomized, patients who accept to participate in the study will be treated with one of three possible treatments: cryosurgery with liquid nitrogen (LN), caustic therapy with 90% trichloroacetic acid (TCA) or the combination of both, TCA followed by LN. The application of LN will consist of 10 subsequent jets of the spray, and the application of the ATA will be performed with a cotton swab. A total of 120 treatments are planned to this study.

  pt-br

  Depois de randomizados, os pacientes que aceitarem participar do estudo serão tratados com um dos três possíveis tratamentos: criocirurgia com nitrogênio líquido (NL), terapia cáustica com ácido tricloroacético 90% (ATA) ou associação de ambos, ATA seguido de NL. A aplicação de NL consistirá de 10 jatos subsequentes do spray, e a aplicação do ATA será realizada com cotonete. Um total de 120 tratamentos são planejados para esse estudo.

• Descriptors:

  en

  14635 Trichloroacetic Acid

  pt-br

  14635 Ácido Tricloroacético

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 02/03/2020 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  120	M	18 Y	0

• Inclusion criteria:

  en

  Male patients with penile warts on gland, foreskin or shaft of the penis, seen at the sexually transmitted infections outpatient clinic of the Botucatu Medical School.

  pt-br

  Pacientes do sexo masculino com verrugas penianas em glande, prepúcio ou haste do pênis, atendidos no ambulatório de infecções sexualmente transmissíveis da Faculdade de Medicina de Botucatu.

• Exclusion criteria:

  en

  Other concurrent genital dermatoses; giant condyloma acuminata, warts outside penis.

  pt-br

  Outras dermatoses genitais concomitantes, condiloma acuminado gigante, verrugas fora do pênis.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	3	Open	Randomized-controlled	3

Outcomes

• Primary outcomes:

  en

  Total clearance of anogenital warts (counting zero)

  pt-br

  Clearance completo das verrugas anogenitais (contagem zero)

• Secondary outcomes:

  en

  Partial clearance of anogenital warts (at least 50% reduction in counting)

  pt-br

  Clearance completo das verrugas anogenitais (ao menos 50% de redução na contagem)

  en

  Counting of anogenital warts

  pt-br

  Contagem das verrugas anogenitais

Contacts

• Public contact
  • Full name: Helio Amante Miot
  • • Address: Distrito de Rubião Junior, s/n
    • City: Botucatu / Brazil
    • Zip code: 18610-000
  • Phone: +55-14-99671-5656
  • Email: heliomiot@gmail.com
  • Affiliation: Faculdade de Medicina de Botucatu (FMB Unesp)
   
• Scientific contact
  • Full name: Helio Amante Miot
  • • Address: Distrito de Rubião Junior, s/n
    • City: Botucatu / Brazil
    • Zip code: 18610-000
  • Phone: +55-14-99671-5656
  • Email: heliomiot@gmail.com
  • Affiliation: Faculdade de Medicina de Botucatu (FMB Unesp)
   
• Site contact
  • Full name: Helio Amante Miot
  • • Address: Distrito de Rubião Junior, s/n
    • City: Botucatu / Brazil
    • Zip code: 18610-000
  • Phone: +55-14-99671-5656
  • Email: heliomiot@gmail.com
  • Affiliation: Faculdade de Medicina de Botucatu (FMB Unesp)
   

Additional links:

• Download in ICTRP format