RBR-2bqy9p randomized clinical trial on actinic keratoses of the face

Date of registration: 06/07/2019 ^(mm/dd/yyyy)
Last approval date : 06/07/2019 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1227-6373

• Public title:

  en

  randomized clinical trial on actinic keratoses of the face

  pt-br

  ensaio clínico randomizado em ceratoses actínicas da face

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 49484715.2.0000.5327
    Issuing authority: plataforma brasil
  • 1.274.217
    Issuing authority: cep hcpa

Sponsors

• Primary sponsor: Universidade Federal do Rio Grande do Sul
• Secondary sponsor:
  • Institution: Universidade Federal do Rio Grande do Sul
• Supporting source:
  • Institution: Universidade Federal do Rio Grande do Sul

Health conditions

• Health conditions:

  en

  actinic keratoses

  pt-br

  Ceratose actínica

• General descriptors for health conditions:

  en

  L00-L99 XII - Diseases of the skin and subcutaneous tissue

  pt-br

  L00-L99 XII - Doenças da pele e do tecido subcutâneo

• Specific descriptors:

Interventions

• Interventions:

  en

  microneedling and drug delivery on face of 42 patients with actinic keratosis with 5-fluorouracil 5% or 5- fluorouracil 0.5% on a hemiface for three-days and use of 5-fluorouracil 5% or 5-fluorouracil 0,5% isolated in the other hemiface for fifteen days . all hemifaces and used drugs have obtained prior randomization criteria

  pt-br

  microagulhamento realizado em 42 pacientes com ceratoses actínicas da face seguido de drug delivery com 5-fluorouracil 5% ou 5-fluorouracil 0,5% em uma hemiface por três dias e uso de 5-fluorouracil 5% ou 0,5% isolado na outra hemiface por quinze dias.todas as hemifaces e fármacos usados obedeceram critérios de randomização prévia

• Descriptors:

  en

  Q65.020 /drug therapy

  pt-br

  Q65.020 /tratamento farmacológico

  es

  Q65.020 /tratamiento farmacológico

  en

  Q22 /drug effects

  pt-br

  Q22 /efeitos dos fármacos

  es

  Q22 /efectos de los fármacos

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 03/31/2016 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  42	-	18 Y	80 Y

• Inclusion criteria:

  en

  patients with actinic keratosis on face with minimum age of eighteen years no history preliminary melanoma

  pt-br

  pacientes com ceratoses actínicas na face com idade superior a dezoito anos sem história de melanoma prévio

• Exclusion criteria:

  en

  renal transplanted patients in use of immunosuppressors history of previous melanoma with health change

  pt-br

  pacientes transplantados renais pacientes com história de melanoma pacientes com dificuldade de cicatrização

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	4	Double-blind	Randomized-controlled	3

Outcomes

• Primary outcomes:

  en

  100% remission of actinic keratosis of the face is expected to be complete with the use of microneedle reduction with the usual 15-day treatment time with 5-fluorouracil in drug delivery. besides reducing the side effects and the number of lesions

  pt-br

  espera-se encontrar a remissão completa de 100% das lesões de ceratose actínica da face com o uso do microagulhamento com redução do habitual tempo de tratamento de 15 dias com o uso do 5-fluorouracil em drug delivery. além de redução dos efeitos colaterais e do número de lesões

• Secondary outcomes:

  en

  partial remission of actinic keratoses total number of lesions at the end of the study

  pt-br

  remissão parcial de ceratoses actinicas número total de lesões no final do estudo

Contacts

• Public contact
  • Full name: Renato Marchiori Bakos
  • • Address: Rua Coronel Bordini, 889
    • City: Porto Alegre / Brazil
    • Zip code: 90440001
  • Phone: + 55-051-33598571
  • Email: rbakos@hcpa.edu.br
  • Affiliation: Universidade Federal do Rio Grande do Sul
   
• Scientific contact
  • Full name: Renato Marchiori Bakos
  • • Address: Rua Coronel Bordini, 889
    • City: Porto Alegre / Brazil
    • Zip code: 90440001
  • Phone: + 55-051-33598571
  • Email: rbakos@hcpa.edu.br
  • Affiliation: Universidade Federal do Rio Grande do Sul
   
• Site contact
  • Full name: Renato Marchiori Bakos
  • • Address: Rua Coronel Bordini, 889
    • City: Porto Alegre / Brazil
    • Zip code: 90440001
  • Phone: + 55-051-33598571
  • Email: rbakos@hcpa.edu.br
  • Affiliation: Universidade Federal do Rio Grande do Sul
   

Additional links:

• Download in ICTRP format