Green Banana Peel Extract for Melasma Treatment

Universidade do Vale do Sapucai

Status and phase: Completed; Phase 1

Conditions: Melasma

Treatments: Biological: SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract; Biological: SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05031689

Melasma

Details and patient eligibility

About

To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.

Full description

Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 60 patients divided into two groups. In the Control Group, SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to SPF 30 sunscreen, pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, evaluated every 30 days through clinical evaluation and MELASQol.

Enrollment: 74 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients with melasma.
• Patients aged 18 years or over and 60 years or less.
• Patients who agree to participate in the study. -

Exclusion criteria

• Patients who have other types of facial hyperchromia.
• Patients who give up, for any reason, to continue treatment.
• Patients who have any type of allergic reaction to the product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups, including a placebo group

SPF 30 and Placebo

Placebo Comparator group

Description:

Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract

Treatment:

Biological: SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract

SPF 30 and pharmaceutical formulation with green banana peel

Active Comparator group

Description:

In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used.

Treatment:

Biological: SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract