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Oral ketotifen associated with oral tranexamic acid for the treatment of facial melasma in women

Oral ketotifen associated with oral tranexamic acid for the treatment of facial melasma in women: a randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-10jn7f39
Enrollment
Unknown
Registered
2024-01-23
Start date
2022-09-01
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

This is a prospective, randomized, comparative, parallel-group, double-blind clinical study. Fifty adult women with facial melasma without prior treatment for at least 30 days will be included. Partic
E05.318.308.980

Sponsors

Universidade Federal de São Paulo - UNIFESP
Lead Sponsor
Universidade Federal de São Paulo - UNIFESP
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adult women aged 18 to 65 will be included, with a clinical diagnosis of facial melasma without previous treatment, except for the use of sunscreen, for at least one month.

Exclusion criteria

Exclusion criteria: Participants with other facial dermatoses, pregnant or lactating women and immunosuppressed women will not be included. Women at risk for thromboembolism: using contraceptives or hormone replacement therapy, smokers, obese, sedentary or with a personal or family history of thrombosis will also be excluded.

Design outcomes

Primary

MeasureTime frame
The expected primary outcome will be the relative reduction in mMASI on D30 and D90 for comparison between groups.

Secondary

MeasureTime frame
Secondary outcomes will be the relative reduction in MELASQol-BP, the difference in luminosity (*L) in colorimetry and histopathological findings, on D30 and D90 between the groups

Countries

Brazil

Contacts

Public ContactDaniel Cassiano

Univesidade Estadual de São Paulo UNIFESP

danielpcassiano@uol.com.br+55(11)996186432

Outcome results

None listed

Source: REBEC (via WHO ICTRP)