Melanosis
Conditions
Interventions
A randomized clinical trial will be conducted at the Teaching Laboratory of Aesthetic Health of the State University of Ponta Grossa. The study will enroll 40 female participants, aged 30 to 60 years,
Melasma Area and Severity Index score
and patient satisfaction (classified as good, imperceptible, or poor improvement). The randomization process will use sequential codes for the two types of formulations, with only one designated resea
Sponsors
Universidade Estadual de Ponta Grossa
Universidade Estadual de Ponta Grossa
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women with facial melasma over 18 years of age; Users of SPF 50 sunscreen
Exclusion criteria
Exclusion criteria: Women under 18 years of age; pregnant or breastfeeding women; women undergoing hormone replacement therapy or treatments with photosensitizing drugs such as tetracycline, spironolactone, phenytoin, and carbamazepine; hypersensitivity to the formulations used in the study; bleeding disorders; skin conditions (facial warts, active or recurrent herpes simplex, seborrheic, atopic, or eczematous dermatitis/dermatosis); history of keloids or hypertrophic scars; immunocompromised patients; patients undergoing chemotherapy or radiotherapy; and patients with a history of using any other therapy for the treatment of melasma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A greater lightening of the spots is expected in the patients who used the formulation containing metformin, evaluated by means of the melasma severity index and by photographs | — |
Secondary
| Measure | Time frame |
|---|---|
| An increase in skin hydration is expected in the patients who used the formulation containing metformin, as evaluated by a skin hydration analyzer. | — |
Countries
Brazil
Contacts
Public ContactPatrícia Boscardin
Universidade Estadual de Ponta Grossa
Outcome results
None listed