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

Evaluation of the efficacy of using Ketotifen associated with Famotidine in the oral 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-7g4gp4
Enrollment
Unknown
Registered
2020-03-20
Start date
2020-03-20
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

Skin disorders

Interventions

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 allocat
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.
Drug
Q65.020

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.—

Secondary

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

Countries

Brazil

Contacts

Public ContactHélio Miot

Faculdade de Medicina de Botucatu (FMB - Unesp)

heliomiot@gmail.com+55-14-38801267

Outcome results

None listed

Source: REBEC (via WHO ICTRP)