Evaluation of the Efficacy and Safety of a product for health in burned skin.

Not Applicable

• Conditions: Burns; C26.200

• Registration Number: RBR-6ws3m6
• Lead Sponsor: Ipclin - Pesquisa Clínica Integrada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified