Cellulite
Conditions
Interventions
This is a prospective, open, randomized and comparative clinical trial. The intended 30 will be divided into two treatment groups. The division of the participants will be done by drawing lots, that i
E02.190.599.750.750
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
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Female participant; participant between 20 and 40 years old; with gynoid lipodystrophy grade II or III in thighs and/or glutes bilaterally; with a body mass index between 18.5 and 29.9 kg/m2
Exclusion criteria
Exclusion criteria: Skin infection; an inflammatory process on the skin; cancerous lesions; psoriasis; active acne; active herpes; in other procedures; in other procedures during the last 6 months; allergic to any asset used; pregnancy or breastfeeding; restrictive diet for weight loss; athlete or high-performance sports
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Cellulite Severity Scale (CSS) or photonumeric cellulite severity scale evaluates the number of evident depressions, the depth of the depressions, the morphological aspect of changes in the skin's surface, the grade of laxity, flaccidity or sagging of the skin and the classification scale by Nürnberger and Müller. Being divided into 5 criteria: (A) Number of evident depressions. This item refers to the total number of depressions evident by visual inspection in the area to be examined. Scores are expressed as: zero = no depression, 1 = A small amount: 1-4 depressions are visible, 2 = A moderate amount: 5-9 depressions are visible, 3 = A large amount: 10 or more depressions are visible. (B) Depth of depressions. This item assesses the depth of depressions by visual inspection of the affected areas. Zero = no depressions, 1 = superficial depressions, 2 = medium depth depressions, 3 = deep depressions. (C) Morphological aspect of skin surface changes. This item evaluates the different morphological patterns of the altered skin surface. Zero = no raised areas, 1 = 'orange peel' appearance, 2 = 'cottage cheese' appearance, 3 = 'mattress' appearance. (D) Grade of laxity, flaccidity or sagging skin. Flaccidity gives the affected skin a draped appearance and this effect worsens the appearance of cellulite. Zero = no skin sagging, 1 = slightly draped appearance, 2 = moderate draped appearance, 3 = severe draped appearance. (E) Classification scale by Nürnberger and Müller: This item is based on the current classification of cellulite. Patients should be evaluated in the standing position with the relaxed gluteus muscles. However, if the patient has no evident depressions, they should be asked to contract the gluteus or the pinch test should be applied (by pinching the skin between the thumb and index finger) in order to differentiate between scores 0 and 1. Zero = zero grade, 1 = first grade, 2 = second grade, 3 = third grade. The classification is determined by the seve | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes, improvements in quality of life related to gynoid lipodystrophy will be assessed through the difference in scores on the cellulite-related quality of life questionnaire (CelluQol) at 0, 30, 60 and 90 days. CelluQol is a cellulite-related quality of life assessment instrument in questionnaire format that assesses the following criteria: How much the fact of having cellulite affects the way you dress, the choice of colors in your clothing, the choice of fabrics of your clothing, choosing a tight fit and wearing short clothes. How much does participation in activities that involve exposing your body in a group (beach, pool), participation in activities that involve exposing your body in a restricted manner (massage) affect your leisure time? How much the fact of having cellulite affects the practice of physical activity and the practice of physical activities that involve exposing the body (swimming, water aerobics). How much it affects your relationship with your partner by exposing your body to your partner, fear of losing your partner, sex life, the fact that your partner notices that you have cellulite. How much the fact of having cellulite affects your feelings (fear, shame, low self-esteem) generating embarrassment, difficulties and doubts about the results of treatments, disbelief, guilt, frustration, discouragement, self-esteem and rebellion. How much the fact of having cellulite affects the change in daily habits such as changes in eating habits, budget compromise and restrictions on other expenses in favor of treating cellulite. It can be answered as 1 for not bothered at all, 2 for not bothered most of the time, 3 for indifferent, 4 for bothered most of the time and 5 for bothered all the time.;The safety related to the interventions will be assessed 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 inter | — |
Countries
Brazil
Contacts
Public ContactGabriela Gomes de Lima
Faculdade de Farmácia da Universidade Federal do Rio de Janeiro
Outcome results
None listed