Facial melasma MedDRA version: 16.1 Level: LLT Classification code 10027161 Term: Melasma System Organ Class: 100000004858
Conditions
Interventions
Product Code: MelanoDerm 4% Crema
Pharmaceutical Form: Cream
INN or Proposed INN: HYDROQUINONE
CAS Number: 123-31-9
Other descriptive name: HYDROQUINONE
Concentration unit: % (W/W) percent weight/weig
Sponsors
Mesoestetic Pharma group S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult women aged between 18-75 years old. Fitzpatrick phototypes I to IV. Presenting noderate to severe facial melasma facial, with a basal MASI Index between 10 and 20. Women of childbearing potential must use an adecuate 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 proecedures. Participation in other clinical trial simultaneously or in the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face.;Secondary Objective: To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face. To assess patient?s satisfaction regarding Melanoderm 4% Crema.;Primary end point(s): MASI Index;Timepoint(s) of evaluation of this end point: Basal, week 4, week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Collection of adverse effects. VAS (Visual Analogic Scale).;Timepoint(s) of evaluation of this end point: Adverse events will be recorded throughout the study and 30 days after the end of treatment. VAS will be completed by the patients at the end of the treatment (week 8). | — |
Countries
Spain
Contacts
Public ContactLiana de Plasencia
Dynamic S.L.
Outcome results
None listed