RBR-4bj4tgd Polydioxanone threads in the treatment of facial melasma

Date of registration: 11/05/2021 ^(mm/dd/yyyy)
Last approval date : 11/05/2021 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code:

• Public title:

  en

  Polydioxanone threads in the treatment of facial melasma

  pt-br

  Fios de polidioxanona no tratamento do melasma facial

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 45891321.0.0000.5411
    Issuing authority: Plataforma Brasil
  • 4.699.661
    Issuing authority: Comitê de ética da Faculdade de Medicina de Botucatu

Sponsors

• Primary sponsor: Faculdade de Medicina de Botucatu (FMB - Unesp)
• Secondary sponsor:
  • Institution: Faculdade de Medicina de Botucatu (FMB - Unesp)
• Supporting source:
  • Institution: Faculdade de Medicina de Botucatu (FMB - Unesp)

Health conditions

• Health conditions:

  en

  Melasma

  pt-br

  Melasma

• General descriptors for health conditions:

  en

  C17 Skin and connective tissue diseases

  pt-br

  C17 Doenças da pele e do tecido conjuntivo

• Specific descriptors:

  en

  Q22 Melasma

  pt-br

  Q22 Melasma

Interventions

• Interventions:

  en

  Intervention group: 6 women with facial melasma. In addition to tinted sunscreen, all participants will be submitted to an application of subcutaneous polydioxanone threads in the zygomatic region affected by melasma, bilaterally, with ten threads on each side, applied in parallel with a distance of 1 cm between them, according to the usual collagen biostimulation protocol. The participants will be evaluated at T0, T60, T120 and T180, and the main outcome will be the mMASI melasma severity scale, compared to the two areas treated with the control area. The MELASQoL quality of life scale, facial colorimetry and adverse effects will also be evaluated. The outcomes will be analyzed, according to the intention of treatment (ITT) and the dropouts will be imputed with the values of the last available visits (LOCF).

  pt-br

  Grupo intervenção: 6 mulheres portadoras de melasma facial. Além do filtro solar com cor, todas as participantes serão submetidas a uma aplicação de fios de polidioxanona subcutânea na região zigomática acometida pelo melasma, bilateralmente, sendo dez fios em cada lado, aplicados em paralelo com distanciamento de 1 cm entre eles, segundo protocolo usual em bioestimulação. As participantes serão avaliadas no T0, T60, T120 e T180, e o principal desfecho será a escala de gravidade do melasma mMASI, comparadas as duas áreas tratadas com área de controle. Serão avaliadas ainda a escala de qualidade de vida MELASQoL, colorimetria facial e efeitos adversos. Os desfechos serão analisados, segundo intenção de tratamento (ITT) e os dropouts serão imputados com os valores das últimas visitas disponíveis (LOCF).

• Descriptors:

  en

  Q65.020 /therapy

  pt-br

  Q65.020 /tratamento

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 05/02/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  6	F	45 Y	60 Y

• Inclusion criteria:

  en

  Women over 45 years old, with facial melasma affecting the zygomatic region bilaterally and another area of the face (control) and phototypes II to V (Fitzpatrick). Participants must avoid sun exposure during the study period.

  pt-br

  Mulheres acima de 45 anos com melasma facial obrigatoriamente acometendo região zigomática bilateralmente e outra área da face (controle) e fototipos II a V (Fitzpatrick). As participantes deverão evitar exposição solar durante o período do estudo.

• Exclusion criteria:

  en

  Pregnant and lactating women; individuals who are using other clarifying substances and those who refuse to be photographed; women who work with photo exposure; carriers of autoimmune diseases; menopausal women;

  pt-br

  Mulheres grávidas e lactantes; indivíduos que estejam utilizando outras substâncias clareadoras e aquelas que se recusarem a ser fotografadas; mulheres que trabalham fotoexpostas; portadoras de doenças autoimunes; mulheres na menopausa;

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Single-group	1	Open	Single-arm-study	N/A

Outcomes

• Primary outcomes:

  en

  The primary outcomes will be the reduction of the mMASI score. Participants will be assessed for primary outcomes at the time points: T0, T60, T120 and T180.

  pt-br

  O desfecho primário será a redução do escore mMASI e do índice colorimétrico nas áreas tratadas e de controle. As participantes serão avaliadas quanto aos desfechos primários nos momentos: T0, T60, T120 e T180.

  en

  The primary outcome will be the reduction of the colorimetric index in the treated and control areas. Participants will be assessed for primary outcomes at the time points: T0, T60, T120 and T180.

  pt-br

  O desfecho primários será a redução do índice colorimétrico nas áreas tratadas e de controle. As participantes serão avaliadas quanto aos desfechos primários nos momentos: T0, T60, T120 e T180.

• Secondary outcomes:

  en

  Secondary outcomes will be evaluated through MELASQoL, dermatoscopy and clinical evaluation by the participant and the researcher, both at T0 and T60 and T90.

  pt-br

  Os desfechos secundários serão avaliados através do MELASQoL, dermatoscopia e avaliação clínica pela participante e pelo pesquisador, tanto no T0 quanto T60 e T90.

Contacts

• Public contact
  • Full name: Helio Amante Miot
  • • Address: Departamento de Dermatologia, SN, Campus Universitário da Unesp
    • City: Botucatu / Brazil
    • Zip code: 18618-000
  • Phone: +55 14 38134727
  • Email: heliomiot@gmail.com
  • Affiliation:
   
• Scientific contact
  • Full name: Helio Amante Miot
  • • Address: Departamento de Dermatologia, SN, Campus Universitário da Unesp
    • City: Botucatu / Brazil
    • Zip code: 18618-000
  • Phone: +55 14 38134727
  • Email: heliomiot@gmail.com
  • Affiliation:
   
• Site contact
  • Full name: Helio Amante Miot
  • • Address: Departamento de Dermatologia, SN, Campus Universitário da Unesp
    • City: Botucatu / Brazil
    • Zip code: 18618-000
  • Phone: +55 14 38134727
  • Email: heliomiot@gmail.com
  • Affiliation:
   

Additional links:

• Download in ICTRP format