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Polydioxanone threads in the treatment of facial melasma

Polydioxanone threads in the treatment of facial melasma: a proof of concept study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4bj4tgd
Enrollment
Unknown
Registered
2021-11-05
Start date
2021-05-02
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

Intervention group: 6 women with facial melasma. In addition to tinted sunscreen, all participants will be submitted to an application of subcutaneous polydioxanone threads in the zygomatic region aff

Sponsors

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

Eligibility

Sex/Gender
Female
Age
45 Years to 60 Years

Inclusion criteria

Inclusion criteria: Women over 45 years old, with facial melasma affecting the zygomatic region bilaterally and another area of the face (control) and phototypes II to V (Fitzpatrick). Participants must avoid sun exposure during the study period.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women; individuals who are using other clarifying substances and those who refuse to be photographed; women who work with photo exposure; carriers of autoimmune diseases; menopausal women;

Design outcomes

Primary

MeasureTime frame
The primary outcomes will be the reduction of the mMASI score. Participants will be assessed for primary outcomes at the time points: T0, T60, T120 and T180.;The primary outcome will be the reduction of the colorimetric index in the treated and control areas. Participants will be assessed for primary outcomes at the time points: T0, T60, T120 and T180.

Secondary

MeasureTime frame
Secondary outcomes will be evaluated through MELASQoL, dermatoscopy and clinical evaluation by the participant and the researcher, both at T0 and T60 and T90.

Countries

Brazil

Contacts

Public ContactHelio Miot
heliomiot@gmail.com+55 14 38134727

Outcome results

None listed

Source: REBEC (via WHO ICTRP)