Burns
Conditions
Interventions
This is a clinical study to evaluate dermatological acceptability and clinical efficacy of research products. It is expected that 36 participants, aged 18-65 years and phototypes from I to VI (Fitzpat
Device
Sponsors
Ipclin - Pesquisa Clínica Integrada
Sterifarma Produtos Cirurgicos Ltda
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age from 18 to 65 years. Gender: male or female. All phototypes. Skin integrity in the test area, selected by the dermatologist, except for possible grade I or II skin burn resulting from radiotherapy. Participants who have given their free and informed consent, are cooperative and aware of the necessity and duration of the controls, so that a perfect adherence to the protocol can be expected. Participants able to read and understand the documents delivered (information leaflet and consent form) and what is explained to them. Participants who agree not to apply any other cosmetic products on the face during the study period, except for the research product and usual hygiene products.
Exclusion criteria
Exclusion criteria: Pregnancy or lactation; Pregnancy or lactation. Skinmarks in the test region that interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, ephelides and nevus in large numbers). Participant with skin problem, in particular: urticaria, edema, eczema, recurrent herpes, herpes zoster occurred in the last 3 months, polycythemia, common acne with onset of nodules or cysts, psoriasis, ichthyosis, lichen planus, lupus, hyperhidrosis. Active dermatoses (local or disseminated) that may interfere with the study results. History of allergic or irritant reactions to topical products: medicines, cosmetics or health correlates of the same category (or other category, but which the investigator considers relevant). History of intense discomfort sensations to topical products: medicines, cosmetics or health correlates of the same category (or other category, but which the researcher considers relevant). Be participating or have participated in another clinical study completed less than 14 days prior to the selection. Any previously unquoted condition which, in the opinion of the investigator, could jeopardize the evaluation of the study; History of absence of adherence or unwillingness to adhere to the study protocol. Professionals directly involved in the realization of this protocol and their relatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to verify the acceptability of the research product in the studied population, after the use of the product in real conditions, guaranteeing to the community the safety of the product. 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 dermatologically safe. | — |
Secondary
| Measure | Time frame |
|---|---|
| Through the participants' perception it is expected to show that the use of the product offers benefits to the prevention of burns | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed