RBR-87kphy Evaluation of a new substance (isobutylamido thiazolyl resorcinolcream) compared to the use of hydroquinone 4% cream to ...

Date of registration: 10/09/2020 ^(mm/dd/yyyy)
Last approval date : 07/07/2021 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1258-9350

• Public title:

  en

  Evaluation of a new substance (isobutylamido thiazolyl resorcinolcream) compared to the use of hydroquinone 4% cream to treat facial blemishes

  pt-br

  Avaliação de uma nova substância (isobutilamido-tiazolyl resorcinol em creme) comparada ao uso de hidroquinona 4% em creme para tratamento de manchas do rosto

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • CAAE: 36914620.3.0000.5411
    Issuing authority: Plataforma Brasil
  • Número do Parecer: 4.301.135
    Issuing authority: Comitê de Ética em Pesquisa da Faculdade de Medicina de Botucatu

Sponsors

• Primary sponsor: Faculdade de Medicina de Botucatu (FMB - Unesp)
• Secondary sponsor:
  • Institution: Escola Paulista de Medicina (EPM/UNIFESP)
• Supporting source:
  • Institution: Faculdade de Medicina de Botucatu (FMB - Unesp)
  • Institution: Escola Paulista de Medicina (EPM/UNIFESP)

Health conditions

• Health conditions:

  en

  Melasma

  pt-br

  Melasma

  es

  Melasma

• General descriptors for health conditions:

  en

  C23 Pathological conditions, signs and symptoms

  pt-br

  C23 Condições patológicas, sinais e sintomas

  es

  C23 Melasma

• Specific descriptors:

  en

  Q22 Melasma

  pt-br

  Q22 Melasma

  es

  Q22 Melasma

Interventions

• Interventions:

  en

  Intervention Group: 25 participants (women with facial melasma); application of 0.2% isobutylamido thiazolyl resorcinol cream 5% cream on the melasma spots (topically) in two layers in the morning and two layers in the morning. During the day, colored facial sunscreen should be used (guidance for reapplication every 3 hours) tinted facial sunscreen SPF 60 (topically). Control group: 25 participants (women with facial melasma); application of 4% hydroquinone in cream (topically) on the stains at night. During the day: application of colored facial sunscreen (guidance for reapplication every 3 hours) tinted facial sunscreen SPF 60 (topically).

  pt-br

  Grupo Intervenção: 25 participantes (mulheres com melasma facial); aplicação de creme de isobutylamido thiazolyl resorcinol 0,2% creme 5% sobre as manchas de melasma (via de administração tópica) em duas camadas pela manhã e duas camadas à. Durante o dia, deve ser utilizado filtro solar facial com cor (orientação para reaplicação a cada 3 horas) filtro solar com cor FPS 60 (via tópica). Grupo controle: 25 participantes (mulheres com melasma facial); aplicação de hidroquinona 4% em creme (via de administração tópica) sobre as manchas a noite. Durante o dia: aplicação de filtro solar facial com cor (orientação para reaplicação a cada 3 horas) filtro solar com cor FPS 60 (via de administração tópica).

• Descriptors:

  en

  Q65.020 /therapy

  pt-br

  Q65.020 /tratamento

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 10/13/2020 ^(mm/dd/yyyy)

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

• Inclusion criteria:

  en

  Women with facial melasma 18 to 50 years old, Fitzpatrick's phototypes II to V.

  pt-br

  Mulheres com melasma facial de 18 a 50 anos, fototipos II a V (Fitzpatrick).

• Exclusion criteria:

  en

  Pregnant and lactating women; women with vitiligo or photosensitizing diseases; individuals who are using other whitening substances and those who refuse to be photographed; photoexposed women and menopausal women (after 50 years).

  pt-br

  Mulheres grávidas e lactantes; portadoras de vitiligo ou doenças fotossensibilizantes; indivíduos que estejam utilizando outras substâncias clareadoras e aquelas que se recusarem a ser fotografadas; mulheres que trabalham fotoexpostas e mulheres na menopausa (após 50 anos).

Study type

• Study design:

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

Outcomes

• Primary outcomes:

  en

  Evaluation of the severity of melasma assessed using the mMASI score (modified Melasma Area and Severity Index); evaluation at T30 (30th day) and T90 (90th day of treatment); a percentage reduction of at least 10% is expected in T90 compared to T0.

  pt-br

  Avaliação da gravidade do melasma avaliada através do Escore mMASI (modified Melasma Area and Severity Index); avaliação no T30 (30º dia) e T90 (90º dia de tratamento); espera-se redução percentual de pelo menos 10% no T90 em relação ao T0.

• 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:

• Previous revision

• Download in ICTRP format