The extra benefit of using topical Clobetasol before Hydroquinone 4% in the treatment of Melasma

Topical Clobetasol as an adjunct treatment to 4% Hydroquinone in moderate to severe facial Melasma: a randomized, double-blind, controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-4mzcwpw

Enrollment

Unknown

Registered

2022-12-28

Start date

2023-01-02

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

The selected participants will be randomized into blocks by computer simulation and allocated consecutively. There will be blinding for participants and researchers characterizing the study as double-

will be delivered in numbered brown envelopes. IThe selected participants will be randomized into blocks by computer simulation and allocated consecutively. There will be blinding for participants and

VS3.003.001.006

Eligibility

Sex/Gender

Female

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Women; age between 18 and 60 years old; with moderate to severe facial melasma or mMasi greater than 5; without treatment for at least 45 days except of the using of sunscreen

Exclusion criteria

Exclusion criteria: Pregnant and lactating women; carriers of other concomitant facial dermatoses; dermatoses with photosensitivity; glaucoma; previous episode of perioral dermatitis; melasma with mMASI less than 5; history of hypersensitivity or local adverse reactions to the use of hydroquinone or clobetasol or any other component of the formulation described

Design outcomes

Primary

Measure	Time frame
It is expected to find a reduction in the mMASI score verified through the application of this score during the serial evaluations. The reduction will be compared according to the generalized linear mixed effects model. In IBM SPSS 25.0 software. Considering the significant value of p = 0.05, two-tailed.	—

Secondary

Measure	Time frame
It is expected to improve the MELASQoL, mMASI, colorimetry parameters, global appearance and clinical assessment by the participant and the researcher through serial reassessments and application of the scores and instruments described. The reduction will be compared according to the generalized linear mixed effects model. In IBM SPSS 25.0 software. Considering the significant value of p = 0.05, two-tailed.	—

Measure

Time frame

It is expected to improve the MELASQoL, mMASI, colorimetry parameters, global appearance and clinical assessment by the participant and the researcher through serial reassessments and application of the scores and instruments described. The reduction will be compared according to the generalized linear mixed effects model. In IBM SPSS 25.0 software. Considering the significant value of p = 0.05, two-tailed.

—

Countries

Brazil

Contacts

Public ContactHélio Miot

Universidade Estadual Paulista (UNESP)

heliomiot@gmail.com+55(14)38134727

Outcome results

None listed

Source: REBEC (via WHO ICTRP)