RBR-73zrnjh Efficacy of the oral use of the drug N-acetylcysteine in the treatment of facial melasma in women

Date of registration: 02/21/2022 ^(mm/dd/yyyy)
Last approval date : 02/21/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1266-3079

• Public title:

  en

  Efficacy of the oral use of the drug N-acetylcysteine in the treatment of facial melasma in women

  pt-br

  Eficácia do uso oral do medicamento N-acetilcisteína no tratamento do melasma facial em mulheres

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • Número parecer CEP: 4.767.182
    Issuing authority: Comitê de Ética em Pesquisa da Faculdade de Medicina de Botucatu
  • CAAE: 46715721.4.0000.5411
    Issuing authority: Plataforma Brasil

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)
  • 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

  N-acetylcysteine intervention group: 25 participants (women with facial melasma); ingestion of one capsule containing n-acetylcysteine 600mg twice a day, morning and evening. During the day, facial sunscreen with color should be used (replication advice every 3 hours) Avène color sunscreen - Dry touch sun emulsion SPF 70 Color - Universal (topical) Control Group: 25 participants (women with facial melasma); ingestion of a capsule containing placebo, with instructions for use identical to the active one, twice a day. During the day, facial sunscreen with color should be used (replication advice every 3 hours) Avène color sunscreen - Dry touch sun emulsion SPF 70 Color - Universal (topical)

  pt-br

  Grupo intervenção N-acetilcisteína: 25 participantes (mulheres com melasma facial); ingestão de uma cápsula contendo n-acetilcisteina 600mg duas vezes ao dia, de manhã e à noite. Durante o dia, deve ser utilizado filtro solar facial com cor (orientação para reaplicação a cada 3 horas) Protetor solar com cor Avène - Emulsão solar toque seco FPS 70 Color - Universal (via tópica) Grupo Controle: 25 participantes (mulheres com melasma facial); ingestão de uma cápsula contendo placebo, com orientação de uso idêntica ao do ativo, duas vezes ao dia. Durante o dia, deve ser utilizado filtro solar facial com cor (orientação para reaplicação a cada 3 horas) Protetor solar com cor Avène - Emulsão solar toque seco FPS 70 Color - Universal (via tópica)

• Descriptors:

  en

  C17.800.621.430.530 Melanosis

  pt-br

  C17.800.621.430.530 Melanose

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 03/01/2022 ^(mm/dd/yyyy)

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

• Inclusion criteria:

  en

  Women with facial melasma 18 to 60 years old, Fitzpatrick's phototypes II to V

  pt-br

  Mulheres com melasma facial de 18 a 60 anos, fototipos II a V (Fitzpatrick)

• Exclusion criteria:

  en

  Patients with other concomitant facial skin diseases, skin diseases with photosensitivity, melasma with mMASI less than 5, history of hypersensitivity to the active substance oral melatonin or to any other component of the formulation described, pregnant or lactating women.

  pt-br

  Portadoras de outras dermatoses faciais concomitantes, dermatoses com fotossensibilidade, melasma com mMASI inferior a 5, história de hipersensibilidade à substância ativa melatonina oral ou a qualquer outro componente da formulação descrita, gestantes ou 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

  Assessment of the severity of melasma assessed through the mMASI Score (modified Melasma Area and Severity Index); evaluation at T0 and T8 (60th day of treatment); a percentage reduction of at least 20% is expected in T8 compared to T0

  pt-br

  Avaliação da gravidade do melasma avaliada através do Escore mMASI (modified Melasma Area and Severity Index); avaliação no T0 e T8 (60º dia de tratamento); espera-se redução percentual de pelo menos 20% no T8 em relação ao T0

• Secondary outcomes:

  en

  Improved quality of life in patients with internationally validated melasma; evaluation at T0 and T8 (60th day of treatment) using the MELASQoL scale;

  pt-br

  Melhora da qualidade de vida em pacientes com melasma internacionalmente validada; avaliação no T0 e T8 (60º dia de tratamento) através da escala MELASQoL;

Contacts

• Public contact
  • Full name: Helio Amante Miot
  • • Address: Distrito de Rubião Junior, s/n
    • City: Botucatu / Brazil
    • Zip code: 18610-000
  • Phone: +55-14-99671-5656
  • Email: heliomiot@gmail.com
  • Affiliation: Faculdade de Medicina de Botucatu (FMB Unesp)
   
• Scientific contact
  • Full name: Helio Amante Miot
  • • Address: Distrito de Rubião Junior, s/n
    • City: Botucatu / Brazil
    • Zip code: 18610-000
  • Phone: +55-14-99671-5656
  • Email: heliomiot@gmail.com
  • Affiliation: Faculdade de Medicina de Botucatu (FMB Unesp)
   
• Site contact
  • Full name: Helio Amante Miot
  • • Address: Distrito de Rubião Junior, s/n
    • City: Botucatu / Brazil
    • Zip code: 18610-000
  • Phone: +55-14-99671-5656
  • Email: heliomiot@gmail.com
  • Affiliation: Faculdade de Medicina de Botucatu (FMB Unesp)
   

Additional links:

• Download in ICTRP format