Facial Melasma
Conditions
Keywords
Facial Melasma
Brief summary
To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face, using a split-face randomization design, evaluating the MASI Score from baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo. To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face. To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.
Interventions
DRUGHydroquinone
DRUGPlacebo
Sponsors
Mesoestetic Pharma Group S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult women aged between 18-65 years old. * Fitzpatrick phototypes I to IV. * Presenting moderate to severe facial melasma facial, with a basal Melasma Area and Severity Index (MASI Index) between 10 and 20. * Women of childbearing potential must use an adequate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment. * Breastfeeding women will not be included in the study. * Having given freely and expressly her informed consent.
Exclusion criteria
* Those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products. * Fitzpatrick phototype V. * Skin pigmentation diseases different to melasma. * Evidence of active cancer disease or diagnosis of cancer in the last year. * Those receiving any topical or oral treatment that could interfere with melasma. * Pregnant or breastfeeding women, or those expecting to get pregnant during the study. * Evidence or suspicion of low compliance with the study visits and procedures. * Participation in other clinical trial simultaneously or in the previous 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face. | Baseline, week 4, week 8. | Efficacy assessments will be measured by the Melasma Area and Severity Index (MASI Index) at baseline, week 4 and week 8 (end of treatment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face. | Week 4, Week 8, Follow-up period (Week 12) | Adverse events will be recorded throughout the study and 30 days after the end of treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To assess patients' satisfaction regarding Melanoderm 4% Crema. | Week 8 | Patients' satisfaction in terms of efficacy and safety will be evaluated by a Visual Analogic Scale at week 8, which will be completed for each side of the face independently. |
Countries
Spain
Outcome results
None listed