RBR-7g4gp4 Effect, safety and action of Ketotifen associated with Famotidine in the treatment of facial stains.

Date of registration: 03/20/2020 ^(mm/dd/yyyy)
Last approval date : 03/20/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1248-0572

• Public title:

  en

  Effect, safety and action of Ketotifen associated with Famotidine in the treatment of facial stains.

  pt-br

  Efeito, segurança e ação de Cetotifeno associado a Famotidina para tratamento de manchas do rosto

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • CAAE: 26340919.0.0000.5411
    Issuing authority: Plataforma Brasil
  • Número do parecer do CEP: 3.823.615
    Issuing authority: Cômite de ética e pesquisa

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

  Skin disorders

  pt-br

  Anormalidades da pele

• 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

  It will be conducted in a randomized clinical trial, as a test, comparative, controlled, double blind and parallel. As participants they will be randomized in blocks by computer simulation and allocated consecutively. All participants, regardless of the most randomized group, receive facial sunscreen with guidance for replication every 3 hours (Vichy® Ideal Soleil with dry touch SPF 50). A group composed of 22 patients who received capsules containing Ketotifen 1 mg associated with Famotidine 20 mg every 12 hours; another group with 22 patients receives Placebo with the same characteristics, available to participants and researchers. The duration of oral procedures will be 8 weeks.

  pt-br

  Ensaio clínico randomizado tipo prova conceito, comparativo, controlado, duplo cego e paralelo. As participantes serão randomizadas em blocos por simulação computacional e alocadas consecutivamente. Todas as participantes receberão filtro solar facial com orientação para reaplicação a cada 3 horas (Vichy® Ideal Soleil com cor toque seco FPS 50) . Um grupo composto por 22 pacientes receberá cápsulas contendo Cetotifeno 1 mg associado a Famotidina 20mg a cada 12horas; outro grupo com 22 pacientes receberá Placebo com as mesmas características, haverá cegamento para os participantes e pesquisadores. A duração dos tratamentos via oral será de 8 semanas.

• Descriptors:

  en

  Q65.020 /drug therapy

  pt-br

  Q65.020 /tratamento farmacológico

  es

  Q65.020 /tratamiento farmacológico

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 03/20/2020 ^(mm/dd/yyyy)
• Date last enrollment: 11/20/2020 ^(mm/dd/yyyy)

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

• Inclusion criteria:

  en

  women; aged 18 to 60 years; moderate to severe facial melasma; no treatment for at least 30 days.

  pt-br

  Mulheres; idade entre 18 e 60 anos; melasma facial moderado a grave; ausência de tratamento há pelo menos 30 dias.

• Exclusion criteria:

  en

  dermatoses with photosensitivity; history of hypersensitivity to ketotifen or famotidine; personal history of liver disease; pregnant women; lactating women.

  pt-br

  Dermatoses com fotossensibilidade; história de hipersensibilidade ao cetotifeno ou famotidina; história pessoal de doença hepática; gestantes; lactantes.

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	N/A

Outcomes

• Primary outcomes:

  en

  Expected outcome 1: reduction of facial melasma pigmentation, verified by variation of the mMASI, in the before and after intervention measurements based on the images photographed in the two moments.

  pt-br

  O desfecho primário será a redução do escore mMASI. A avaliação do mMASI será realizada por pesquisador “cego” quanto aos grupos alocados, a partir das imagens fotografadas nos dois momentos .

• Secondary outcomes:

  en

  Expected outcome 2: reduction of facial melasma pigmentation, verified by colorimetric index variation.

  pt-br

  Os desfechos secundários serão avaliados através do MELASQoL, dermatoscopia, colorimetria (diferencial entre pele sã e melasma) e avaliação clínica pela participante e pelo pesquisador

Contacts

• Public contact
  • Full name: Hélio Amante Miot
  • • Address: Rua Magnólia, 400
    • City: Botucatu / Brazil
    • Zip code: 18607-670
  • Phone: +55-14-38801267
  • Email: heliomiot@gmail.com
  • Affiliation: Faculdade de Medicina de Botucatu (FMB - Unesp)
   
• Scientific contact
  • Full name: Hélio Amante Miot
  • • Address: Rua Magnólia, 400
    • City: Botucatu / Brazil
    • Zip code: 18607-670
  • Phone: +55-14-38801267
  • Email: heliomiot@gmail.com
  • Affiliation: Faculdade de Medicina de Botucatu (FMB - Unesp)
   
• Site contact
  • Full name: Hélio Amante Miot
  • • Address: Rua Magnólia, 400
    • City: Botucatu / Brazil
    • Zip code: 18607-670
  • Phone: +55-14-38801267
  • Email: heliomiot@gmail.com
  • Affiliation: Faculdade de Medicina de Botucatu (FMB - Unesp)
   

Additional links:

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