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

Efficacy of the use of oral N-acetylcysteine in the treatment of facial melasma in women: A randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-73zrnjh
Enrollment
Unknown
Registered
2022-02-21
Start date
2022-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Interventions

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 s
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 ho

Sponsors

Faculdade de Medicina de Botucatu (FMB - Unesp)
Lead Sponsor
Faculdade de Medicina de Botucatu (FMB - Unesp)
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

Secondary

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

Countries

Brazil

Contacts

Public ContactHelio Miot

Faculdade de Medicina de Botucatu (FMB Unesp)

heliomiot@gmail.com+55-14-99671-5656

Outcome results

None listed

Source: REBEC (via WHO ICTRP)