Melanose
Conditions
Interventions
The intended 45 will be divided into three treatment groups. The division of the participants will be done by drawing lots, that is, at random, so that there is no possibility of predicting the alloca
Código DeSC: E02.190.292
Sponsors
Faculdade de Farmácia da Universidade Federal do Rio de Janeiro
Unidade de Farmácia da Universidade do Estado do Rio de Janeiro Campus Zona Oeste
Eligibility
Sex/Gender
Female
Age
25 Years to 60 Years
Inclusion criteria
Inclusion criteria: Female participant; participant between 25 and 60 years old; with melasma
Exclusion criteria
Exclusion criteria: Skin infection; an inflammatory process in the skin; cancerous lesions; psoriasis; active acne; active herpes; autoimmune disease; clotting disorders; using anticoagulant; in chronic use of anti-inflammatory drugs; using isotretinoin; in other procedures; allergic to any asset used; history of hypertrophic; history of keloid scarring; pregnancy; breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the severity of melasma, the MASI (Melasma Area and Severety Index), a useful measure in the clinical classification of melasma, has been the most used method in the literature to assess the response to treatment. The MASI score is calculated by evaluating three factors: area (A) of involvement, darkness (D) and homogeneity (H), with forehead (F), right malar region (RM), left malar region (LM) and chin (C), corresponding to 30%, 30%, 30% and 10% of the total face, respectively. The area of ??involvement in each of these 4 areas receives a numerical value from 0 to 6 (0 = no involvement; 1 = up to 10%; 2 = 10% to 29%; 3 = 30% to 49%; 4 = 50% to 69%; 5 = 70% to 89%; and 6 = 90% to 100%). Darkness and homogeneity are rated on a scale of 0 to 4 (0 = absent; 1 = mild; 2 = moderate; 3 = marked; and 4 = maximum). The MASI score is calculated by summing the severity ratings for darkness and homogeneity, multiplied by the area of ??involvement value, for each of the 4 facial areas. MASI = Forehead 0.3A (D+H) + Right Malar 0.3A (D+H) + Left Malar 0.3A (D+H) + Chin 0.3A (D+H). The total score range is from 0 to 48. (PANDYA et al., 2011). More recently, a new quantitative and scientific scoring system, the modified MASI, was created to replace the classic MASI scoring system. This new method uses image analysis under ultraviolet light. (HAMMERSCHMIDT et al., 2012). Area (A) and darkness (D) are classified as follows: area of ??involvement: 0 = absent, 1 = up to 10%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50 % to 69%, 5 = 70% and 89% and 6 = 90% and 100%; darkness: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = severe. Modified MASI = Forehead 0.3A D + Right cheekbone 0.3A D + Left cheekbone 0.3A D + Chin 0.1A D. The total score range is 0 to 24 (PANDYA et al., 2011). | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement quality of life related to melasma - Response to treatment will be evaluated on days 30, 60 and 90, also according to the three scoring methods. The MELASQol (Melasma Quality of Life Scale), a questionnaire capable of objectively evaluating the quality of life of affected participants. Questionnaire questions consider how they feel about melasma in the last week before the assessment as: Not at all bothered = 1, not bothered most of the time = 2, not bothered sometimes = 3, neutral = 4, bothered sometimes = 5, bothered most of the time = 6, or bothered all the time = 7. For the questions: 1. The appearance of your skin. 2. Frustration over the condition of your skin. 3. Embarrassment by the condition of your skin. 4. Feeling depressed about your skin condition. 5. The effects of your skin condition on relationships with other people (eg interactions with family, friends, intimate relationships, etc.). 6. The effects of your skin condition on your desire to be with people. 7. Your skin condition makes it difficult to show affection. 8. Skin blemishes make you feel unattractive to others. 9. Skin blemishes make you feel less important or productive. 10. Skin blemishes affect your sense of freedom. (CESTARI, et al., 2006; BALKRISHNAN R, et al., 2003);The safety related to the interventions will be evaluated through the number of participants who report adverse events, number of adverse events, duration of the adverse event and number of dropouts due to undesirable adverse events for the intervention and control groups. The notification of adverse events will occur throughout the treatment and follow-up period, and the researcher must be informed by the participant immediately when the adverse event occurs. | — |
Countries
Brazil
Contacts
Public ContactJenifer Santos
Faculdade de Farmácia da Universidade Federal do Rio de Janeiro
Outcome results
None listed