Abdominal Fat
Conditions
Interventions
F02.463.785.477
This is a study of the effectiveness of skin protection during the procedure of cryolipolysis the product (MANTA PARA CRIOLIPÓLISE). It will be coupled with the Crioredux equipment from the manufactur
and in localized fat reduction of the abdominal region, in which it will be applied by the trained professional (esthetician).
It is expected the inclusion of 35 female participants, aged 18 to 65 yea
Device
Sponsors
Ipclin - Pesquisa Clínica Integrada
VITA VERT INDUSTRIA E COMERCIO DE COSMETICOS LTDA
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 30 participants in total. age group from 18 to 65 years. female or male. in the study regions. phototypes I to IV (according to the Fitzpatrick classification). participants agreeing to follow the procedures and requirements of the study and participating in the Institution at the time and date determined for the evaluation. Have been clarified about the research (objective, methodology, duration, risks and expected benefits). Participants who have the capacity to consent to their participation. sign the Free and Informed Consent Form; (TCLE). Participants who agree not to use products of the same category during this survey. Participants who wish to participate in the study without financial gain. They will only be refunded for expenses like food. Participants who did not participate in similar studies for at least two months prior to the study. Participants who declared that there was no risk of pregnancy during the study period.
Exclusion criteria
Exclusion criteria: Diabetes. Skin diseases. vitiligo. psoriasis. lupus. atopic dermatitis. Skin marks in the experimental area that interfere with the evaluation of possible skin reactions. Active dermatoses (local and disseminated) that may interfere with the study results. Pregnant or nursing mothers. History of allergic reactions. irritation or intense discomfort sensations the product category tested. Participants with a history of allergy to the material used in the study. History of atopy. Immunodeficiency carriers. Renal, cardiac or hepatic transplanted. Intense sun exposure or tanning session up to 15 days prior to the initial evaluation. Prediction of intense sun exposure or the tanning session during the study driving period. Forecast to take a bath, pool or sauna during the study. Use of the following topical systemic medicinal products: immunosuppressants, antihistamines, non-hormonal anti-inflammatories, and corticosteroids up to two weeks prior to selection. Treatment with acid vitamin A and / or its derivatives oral or topical up to 01 month before the start of the study. Prediction of vaccination during the study or up to 03 weeks before the study. Be participating in another study. Any condition not mentioned above that, in the opinion of the investigator, could compromise the evaluation of the study. History of absence of adherence or unwillingness to adhere to the study protocol. Professionals directly involved in the implementation of this protocol and their families
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that under normal conditions of use the product under investigation (MANTA PARA CRIOLIPÓLISE) is able to protect the skin and reduce fat measurements of the participants included in the study. The sensations of discomfort and clinical signs of each participant will be evaluated by a dermatologist and, if at least 70% of the participants do not report / show feelings of discomfort or clinical signs, the product will be considered dermato and gynecologically safe. | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical efficacy of the product was verified in the abdominal region, it helps to protect the skin after application cryolipolysis with the Crioredux equipment with the trained professional | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed