RBR-4mzcwpw The extra benefit of using topical Clobetasol before Hydroquinone 4% in the treatment of Melasma

Date of registration: 12/28/2022 ^(mm/dd/yyyy)
Last approval date : 12/28/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1281-6589

• Public title:

  en

  The extra benefit of using topical Clobetasol before Hydroquinone 4% in the treatment of Melasma

  pt-br

  O benefício extra do uso do Clobetasol tópico antes da Hidroquinona 4% no tratamento do Melasma

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 59640922.0.0000.5411
    Issuing authority: Plataforma Brasil
  • 5.532.720
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Estadual Paulista (UNESP)

Sponsors

• Primary sponsor: Universidade Estadual Paulista (UNESP)
• Secondary sponsor:
  • Institution: Universidade Estadual Paulista (UNESP)
• Supporting source:
  • Institution: Universidade Estadual Paulista (UNESP)

Health conditions

• Health conditions:

  en

  Melasma

  pt-br

  Melasma

• General descriptors for health conditions:

  en

  C17.800 Skin Diseases

  pt-br

  C17.800 Dermatopatias

• Specific descriptors:

  en

  C17.800.621.430.530 Melasma

  pt-br

  C17.800.621.430.530 Melasma

Interventions

• Interventions:

  en

  The selected participants will be randomized into blocks by computer simulation and allocated consecutively. There will be blinding for participants and researchers characterizing the study as double-blind. The bottles containing the dermatological creams will be separated and numbered by a third doctor who will not participate in the other stages of the trial, they will contain identical packaging for both groups, as well as the color of the content; will be delivered in numbered brown envelopes. IThe selected participants will be randomized into blocks by computer simulation and allocated consecutively. There will be blinding for participants and researchers. The bottles containing the dermatological creams will be separated and numbered by a third doctor who will not participate in the other stages of the work, they will contain identical packaging for both groups, as well as the color of the content and it will be delivered in numbered brown envelopes. The intervention group will consist of 25 women with facial melasma who will apply 0.05% clobetasol cream at night for 2 weeks, followed by use of 4% hydroquinone cream once a night for another 6 weeks. During the day, they should use a broad spectrum sunscreen with color every 3 hours. The control group will have 25 women with facial melasma who will apply 4% hydroquinone cream at night for 8 weeks. During the day, this group should also use a broad spectrum sunscreen with color every 3 hours.

  pt-br

  As participantes selecionadas serão randomizadas em blocos por simulação computacional e alocadas consecutivamente. Haverá cegamento para os participantes e pesquisadores, caracterizando o estudo como duplo-cego. Os frascos contendo os cremes dermatológicos serão separados e numerados por um terceiro médico que não participará das demais etapas do trabalho, conterão embalagem idêntica para ambos os grupos, bem como cor do conteúdo e serão entregues dentro de envelopes pardos numerados. O grupo intervenção será composto por 25 mulheres com melasma facial que aplicarão clobetasol creme 0,05% a noite, por 2 semanas, seguido por uso de hidroquinona creme 4% , 1 vez a noite, por mais 6 semanas. Durante o dia, deverão utilizar filtro solar de amplo espectro com cor a cada 3 horas. O grupo controle terá 25 mulheres com melasma facial que aplicarão hidroquinona creme 4%, a noite por 8 semanas. Durante o dia, esse grupo também deverá utilizar filtro solar de amplo espectro com cor a cada 3 horas.

• Descriptors:

  en

  VS3.003.001.006 Therapeutics

  pt-br

  VS3.003.001.006 Terapêutica

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 01/02/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  50	F	18 Y	60 Y

• Inclusion criteria:

  en

  Women; age between 18 and 60 years old; with moderate to severe facial melasma or mMasi greater than 5; without treatment for at least 45 days except of the using of sunscreen

  pt-br

  Mulheres; entre 18 e 60 anos; com melasma facial moderado a grave ou mMasi maior que 5; sem tratamento há pelo menos 45 dias exceto pelo uso de filtro solar

• Exclusion criteria:

  en

  Pregnant and lactating women; carriers of other concomitant facial dermatoses; dermatoses with photosensitivity; glaucoma; previous episode of perioral dermatitis; melasma with mMASI less than 5; history of hypersensitivity or local adverse reactions to the use of hydroquinone or clobetasol or any other component of the formulation described

  pt-br

  Mulheres grávidas e lactantes; portadoras de outras dermatoses faciais concomitantes; dermatoses com fotossensibilidade; glaucoma; episódio prévio de dermatite perioral; melasma com mMASI inferior a 5; história de hipersensibilidade ou reações adversas locais ao uso da hidroquinona ou do clobetasol ou a qualquer outro componente da formulação descrita

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Double-blind	Randomized-controlled	3

Outcomes

• Primary outcomes:

  en

  It is expected to find a reduction in the mMASI score verified through the application of this score during the serial evaluations. The reduction will be compared according to the generalized linear mixed effects model. In IBM SPSS 25.0 software. Considering the significant value of p ≤ 0.05, two-tailed.

  pt-br

  Espera-se encontrar redução do escore mMASI verificado por meio da aplicação desse escore durante as avaliações seriadas. A redução será comparada segundo o modelo linear generalizado de efeitos mistos. No software IBM SPSS 25.0. Considerado o valor significativo de p ≤ 0,05, bicaudal.

• Secondary outcomes:

  en

  It is expected to improve the MELASQoL, mMASI, colorimetry parameters, global appearance and clinical assessment by the participant and the researcher through serial reassessments and application of the scores and instruments described. The reduction will be compared according to the generalized linear mixed effects model. In IBM SPSS 25.0 software. Considering the significant value of p ≤ 0.05, two-tailed.

  pt-br

  Espera-se obter a melhora dos scores MELASQoL, mMASI, dos parâmetros de colorimetria, aspecto global e avaliação clínica pela participante e pelo pesquisador por meio da realização de reavaliações seriadas e aplicação dos escores e instrumentos descritos. redução será comparada segundo o modelo linear generalizado de efeitos mistos. No software IBM SPSS 25.0. Considerado o valor significativo de p ≤ 0,05, bicaudal.

Contacts

• Public contact
  • Full name: Hélio Amante Miot
  • • Address: Departamento de Dermatologia, Anexo Vermelho, segundo andar, s/n, Campus Universitário da Universidade Estadual Paulista (UNESP)
    • City: Botucatu / Brazil
    • Zip code: 18618-687
  • Phone: +55(14)38134727
  • Email: heliomiot@gmail.com
  • Affiliation: Universidade Estadual Paulista (UNESP)
   
• Scientific contact
  • Full name: Hélio Amante Miot
  • • Address: Departamento de Dermatologia, Anexo Vermelho, segundo andar, s/n, Campus Universitário da Universidade Estadual Paulista (UNESP)
    • City: Botucatu / Brazil
    • Zip code: 18618-687
  • Phone: +55(14)38134727
  • Email: heliomiot@gmail.com
  • Affiliation: Universidade Estadual Paulista (UNESP)
   
• Site contact
  • Full name: Hélio Amante Miot
  • • Address: Departamento de Dermatologia, Anexo Vermelho, segundo andar, s/n, Campus Universitário da Universidade Estadual Paulista (UNESP)
    • City: Botucatu / Brazil
    • Zip code: 18618-687
  • Phone: +55(14)38134727
  • Email: heliomiot@gmail.com
  • Affiliation: Universidade Estadual Paulista (UNESP)
   

Additional links:

• Download in ICTRP format