FindTrial
Sign In

The benefit of Nicotinamide + Vitamin C + Hyaluronic Acid, compared to Hydroquinone in the treatment of Melasma

Efficacy and safety topical Nicotinamide 10%, associated with VCPMG 5% and Hyaluronic Acid 5%, compared to Hydroquinone 4% tested in Brazilian women with Melasma: a double-blind, randomized and controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4mkfmr8
Enrollment
Unknown
Registered
2023-03-20
Start date
2023-02-01
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

A double-blind blinding study will be carried out and the allocation will be randomized and controlled. Intervention Group: 25 participants (women with facial melasma)
application of 10% nicotinamide, associated with VCPMG 5% and hyaluronic acid cream gel on melasma patches (topical administration route) twice a day, for 8 weeks. During the day, facial sunscreen sho
sunscreen SPF 60 (topical). Control group: 25 participants (women with facial melasma)
application of 4% hydroquinone in cream gel (topical administration route) on the spots at night and cream gel containing placebo on the spots in the morning. During the day: application of facial sun
VS3.003.001.006

Sponsors

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista
Lead Sponsor
Faculdade de Medicina de Botucatu, Universidade Estadual Paulista
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Women; age between 18 and 60 years; with facial melasma; Fitzpatrick phototypes 2 to 5

Exclusion criteria

Exclusion criteria: Pregnant or lactating women; women using other bleaches; women who refuse to be photographed

Design outcomes

Primary

MeasureTime frame
Reduction in the severity of melasma that will be evaluated through the mMASI Score (modified Melasma Area and Severity Index) and a percentage reduction of at least 10% is expected at the end of treatment when compared to the beginning—

Secondary

MeasureTime frame
Global clinical improvement is expected, assessed using the MELASQoL and GAIS scale—

Countries

Brazil

Contacts

Public ContactHelio Miot

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista

heliomiot@gmail.com+55 14 38134727

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 5, 2026