RBR-373nm7 Assessment of pain and side effects between industrialized ointment with Lidocaine and manipulated Lidocaine ointment…

Date of registration: 09/22/2020 ^(mm/dd/yyyy)
Last approval date : 09/22/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1256-6926

• Public title:

  en

  Assessment of pain and side effects between industrialized ointment with Lidocaine and manipulated Lidocaine ointment with Tetracaine for Hair Removal with Laser LightSheer®

  pt-br

  Avaliação da dor e efeitos colaterais entre pomada industrializada com Lidocaína e pomada manipulada de Lidocaína com Tetracaína para Remoção de Pelos com Laser LightSheer®

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 1255
    Issuing authority: Comitê de Ética em Pesquisa da Unoeste

Sponsors

• Primary sponsor: Clínica Dermatológica Dra Luciena Ortigosa
• Secondary sponsor:
  • Institution: Clínica Dermatológica Dra Luciena Ortigosa
• Supporting source:
  • Institution: Clínica Dermatológica Dra Luciena Ortigosa

Health conditions

• Health conditions:

  en

  Pain; Hair Removal; Anesthetics

  pt-br

  Dor; Remoção de Cabelo; Anestésicos

• General descriptors for health conditions:

  en

  C17 Skin and connective tissue diseases

  pt-br

  C17 Doenças da pele e do tecido conjuntivo

  es

  C17 Enfermedades de la piel y tejido conjuntivo

• Specific descriptors:

Interventions

• Interventions:

  en

  Seventy-seven patients participated in the study, with each patient being able to perform more than one procedure, resulting in a total of 256 procedures. Sixty minutes before the laser procedure, the topical anaesthetics were applied. Commercial lidocaine 4% in half of the area and the compounded formulation of lidocaine 23% and tetracaine 7% in the other half of the area to be treated: axillae, face, legs or groin. The substance that should be applied on each side of the body, as well as which side of the body the laser should be applied first was chosen randomly, as a double-blind study. The intensity was evaluated through the use of the visual analogue scale (VAS). The data were analysed by comparing the figures obtained with the VAS according to each area evaluated.

  pt-br

  Setenta e sete pacientes participaram do estudo, podendo cada paciente realizar mais de um procedimento, resultando em um total de 256 procedimentos. Sessenta minutos antes do procedimento a laser, os anestésicos tópicos foram aplicados. Lidocaína comercial 4% em metade da área (hemicorpórea) e a formulação composta de lidocaína 23% e tetracaína 7% na outra metade da área (hemicorpo contralateral) a ser tratada: axilas, face, pernas ou virilha. A substância que deveria ser aplicada em cada lado do corpo, bem como em qual lado do corpo o laser deveria ser aplicado primeiro foi escolhida aleatoriamente, como um estudo duplo-cego. A intensidade foi avaliada por meio da utilização da escala visual analógica (EVA). Os dados foram analisados comparando-se os valores obtidos com a EVA de acordo com cada área avaliada.

• Descriptors:

  en

  E07.632.490 Lasers

  pt-br

  E07.632.490 Lasers

  es

  E07.632.490 Rayos Láser

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 05/11/2012 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  77	-	12 -	90 -

• Inclusion criteria:

  en

  Patients with a desire for epilation; Patients with pigmented hair in axilla, face, legs or groin; Both sexes; Age between 12 and 90 years

  pt-br

  Pacientes com desejo de epilação; Pacientes com pelos pigmentados em axilas, face, pernas ou virilha; Ambos os sexos; Idade entre 12 e 90 anos

• Exclusion criteria:

  en

  Patients with a history of allergic reaction to lidocaine or tetracaine; Patients with keloid; Sun exposure in the four weeks prior to the laser procedure

  pt-br

  Pacientes com história de reação alérgica a lidocaína ou tetracaína; Pacientes com queloide; Exposição solar nas quatro semanas anteriores ao procedimento a laser

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Other	2	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  To evaluate topical anesthetic with greater antialgic effects using the Wilcoxon's non parametric test. P-values lower than 0.05 were considered as statistically significant.

  pt-br

  Avaliar o anestésico tópico com maior efeito antiálgico usando o teste não paramétrico de Wilcoxon. Valores de probabilidade menores que 0,05 foram considerados como estatisticamente significativos.

• Secondary outcomes:

  en

  Secondary outcomes were not expected

  pt-br

  Desfechos secundários não foram esperados

Contacts

• Public contact
  • Full name: Yara Martins Ortigosa Leonardo
  • • Address: Rua Domiciano Rossi, 600 Apto 152 H
    • City: São Bernardo do Campo / Brazil
    • Zip code: 09726-121
  • Phone: +55011998501338
  • Email: yara_mot@hotmail.com
  • Affiliation: Clínica Dermatológica Dra Luciena Ortigosa
   
• Scientific contact
  • Full name: Yara Martins Ortigosa Leonardo
  • • Address: Rua Domiciano Rossi, 600 Apto 152 H
    • City: São Bernardo do Campo / Brazil
    • Zip code: 09726-121
  • Phone: +55011998501338
  • Email: yara_mot@hotmail.com
  • Affiliation: Clínica Dermatológica Dra Luciena Ortigosa
   
• Site contact
  • Full name: Yara Martins Ortigosa Leonardo
  • • Address: Rua Domiciano Rossi, 600 Apto 152 H
    • City: São Bernardo do Campo / Brazil
    • Zip code: 09726-121
  • Phone: +55011998501338
  • Email: yara_mot@hotmail.com
  • Affiliation: Clínica Dermatológica Dra Luciena Ortigosa
   

Additional links:

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