Chloasma (Melasma)
Conditions
Interventions
Interventions:
1. Cosmetic gel cream for the topical application Basic formulation composed of emulsifiers, emollients, polymers (gel), humectants and preservatives.
1A- topical formulation containing
Dietary supplement
Other
VS2.003.004
G07.203.300.456
Sponsors
Faculdade de Ciências Farmacêuticas de Riberão Preto - USP
Faculdade de Ciências Farmacêuticas de Riberão Preto - USP
Eligibility
Sex/Gender
Female
Age
30 Years to 50 Years
Inclusion criteria
Inclusion criteria: 30 to 50 years old; phototype III and IV (Fitzpatrick, 1998); facial hyperpigmentations patterns.
Exclusion criteria
Exclusion criteria: hyperpigmentations not diagnosed as melasma in the malar region; pregnancy or breastfeeding; individuals with a history of adverse reactions with the use of cosmetic products; individuals in the use of drugs capable of producing an abnormal skin response; cosmetic and dermo-cosmetic whitening treatments, superficial chemical peels and laser for less than 3 months; use of oral antioxidant supplementation for less than 3 months; localized or generalized dermatological diseases; excess hair on face.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: significant difference of the severity index and melasma area (mMASI) between the groups in each time evaluated, obtained through the method: The measure of the primary variable - Melasma Area and Severity Index (MMASI) - was calculated by a subjective evaluation of the researcher on two factors: area involved (A) and pigmentation (P), in the regions: (f), right malar (md), left malar (me) and chin chin (q), corresponding to 30%, 30%, 30% and 10%, respectively. For the area involved in these 4 regions a numerical value of 0 to 6: 0 = without involvement is provided; 1 <10%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%. The pigmentation is classified as 0 to 4: 0 = absent; 1 = slight; 2 = moderate; 3 = accentuated; 4 = intense. The mMASI is then calculated by adding the sum of the severity ratings for the pigmentation multiplied by the value of the area of ??involvement in the 4 facial regions (PANDYA et al, 2011). Thus, this assigned index will be compared among the four study groups by statistical analysis. So, the outcome would be whether or not there is a significant difference by the ANOVA statistical test for the comparison of the 4 groups under study of the mMASI variable described in the course of the study comparing the time: baseline, 30, 60 and 90 days.;Outcome 1: no significant difference between melasma severity index and area (mMASI) between groups at each evaluated time, obtained through the method: The measure of the primary variable - Melasma Area and Severity Index (MMASI) - was calculated by a subjective evaluation of the researcher on two factors: area involved (A) and pigmentation (P), in the regions: (f), right malar (md), left malar (me) and chin chin (q), corresponding to 30%, 30%, 30% and 10%, respectively. For the area involved in these 4 regions a numerical value of 0 to 6: 0 = without involvement is provided; 1 <10%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%. The pigmentation is classifi | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: no significant difference in the variable - measure of transepidermal loss of water - between the groups in the measurement times, obtained by the method: the use of TM 210 (Courage & Khazaka Electronic GmbH, Köln, Germany) was used to measure water evaporation from the skin surface, thus the transepidermal loss of water in the unit g / h / m2 (WAGEMAKER et al. 2015). Thus, this attributed measure will be compared between the four groups of the study by statistical analysis. So, the outcome would be whether or not there is a significant difference by the ANOVA statistical test for the comparison of the 4 groups under study of the mMASI variable described in the course of the study comparing the time: baseline, 30, 60 and 90 days..;Conclusion 1: no significant difference in the variable - measure of transepidermal loss of water - between the groups in the measurement times, obtained by the method: the use of TM 210 (Courage & Khazaka Electronic GmbH, Köln, Germany) was used to measure water evaporation from the skin surface, thus the transepidermal loss of water in the unit g / h / m2 (WAGEMAKER et al. 2015). So, the outcome was that there was no significant difference by the ANOVA statistical test for the comparison of the 4 groups under study of the mMASI variable described in the course of the study comparing the time: baseline, 30, 60 and 90 days. | — |
Countries
Brazil
Contacts
Public ContactJulia ;Patricia Bagatin;Maia Campos
Faculdade de Ciências Farmacêuticas de Riberão Preto - USP;Faculdade de Ciências Farmacêuticas de Riberão Preto - USP
Outcome results
None listed