cellulite
Conditions
Interventions
Evaluation of Cellulite-Reducing Dermatological Clinical Effectiveness
To assess the clinical effectiveness of the product in the 30 participants, the following parameters will be observed: The produc
Reduced the appearance of orange peel
Reduced the appearance of waviness in the skin
It left the skin smoother
Reduced sagging skin, making it firmer
Reduced swelling in
place of application of the product
Reduced measures at the product application site
Reduced fat located at the product application site
The product prevented the skin from drying out, leaving it more hydrated
The product reduced the roughness of the skin, leaving it softer
Improved the overall appearance of
skin
, and these will be classified and / or quantified before (D0) and after 30 ± 2 days (D30) of the use of the product, by subjective analysis, that is, visual analysis by the dermatologist and register
Other
L03.9
Sponsors
Malwee Malhas Ltda,
Malwee Malhas Ltda,
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Age from 18 to 45 years; Women; Healthy participants (evaluated by the dermatologist); Phototypes I to IV (according to the Fitzpatrick classification), due to the study of acceptability and the possibility of quickly detecting skin reactions with this scale; Presence of cellulite in the experimental region (buttocks and thighs); Presence of grade I, II, III and IV cellulite; Participants who accept not to change the normal daily routine of their cosmetic habits, except for the use of topical products with activity similar to the test product during the entire study, these do not must be used; The Informed Consent Form (ICF) has been clarified and signed; Participants who want to participate in the study without financial profit. They will be reimbursed for expenses related to the test, such as transportation and food, among others; Participants who have not participated in similar studies for at least 2 months prior to study; Regular / occasional users of cosmetic products similar to the product under investigation; Participants who declared they were not at risk of pregnancy during the survey period
Exclusion criteria
Exclusion criteria: Allergy to the tested product category; Pregnancy or lactation; Immunodeficiencies; Active atopic dermatitis; Kidney, heart or liver transplantation; Use of the following medications: corticosteroids, antihistamines, immunosuppressants, retinoids, anti-inflammatories; Any condition that may interfere with the evaluations according to the Investigator of the study; Participants who refuse to participate in the study in question. Note: the participants included are instructed not to change their diet, cosmetic and hygiene habits, exercise routine and contraceptive method. Also, not to use products of the same product category tested in the experimental region
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to prove the acceptability of the investigational product, capable of promoting non-sensitization and allergy to the 30 participants included in the study, from using the product at home for 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to prove the effectiveness of the investigational product, under normal conditions of use, capable of promoting the reduction of cellulite in the region where it will be applied, and / or improving the appearance of the skin of the participants included in the study. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed