Dermatological test on revitalizing lotion and restorative lotio

Not Applicable

• Conditions: Skin aging; G13.750

• Registration Number: RBR-3hnmbdt
• Lead Sponsor: Kosmoscience Ciência e Tecnologia Cosm Imp Exp Ltda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-02
• Last Update Posted: 29 May 2023
• Study Completion: 2023-12-15

Recruitment & Eligibility

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

Inclusion Criteria

Healthy research participant; age range between 18 and 70 years; both sexes; phototype (Fitzpatrick): I to IV; agree to adhere to the requirements of the study in combating the COVID-19 pandemic, through preventive measures: use a mask as recommended by the WHO; use the mask while traveling to the research center and during study procedures; maintain social distancing; frequently wash your hands with soap and/or alcohol gel and attend the research center only at scheduled times to avoid crowds; agreement not to wet the site during the entire test period; understand the test procedures and agree to adhere to the study requirements; absence of inflammatory dermatoses or tattooing at the application site; signature of the Free and Informed Consent Term (TCLE)

Exclusion Criteria

Gestation; lactation; participants who have hyperthermia (body temperature greater than or equal to 37.5°C); participants who have been diagnosed with COVID-19 by RT-PCR test or by the presence of IgM antibodies in the serology test, in the last 4 weeks or who are showing the following symptoms: dry or productive cough, sneezing, runny nose, body pain , headache, anosmia (loss of smell), ageusia (loss of taste) and/or any other symptom that may be related to covid-19 at the discretion of the investigator; participant who belongs to the risk group for COVID-19, that is, with chronic cardiovascular, renal and respiratory problems, immunosuppression or other conditions that the doctor judges as belonging to the risk group; participants with heart diseases (for example, but not limited to: atrial fibrillation, obstructive coronary artery disease); participants with kidney and/or neurological diseases; participants with severe or decompensated pulmonary and/or respiratory diseases; use of corticoids, antihistamines and/or anti-inflammatories; presence of localized or generalized dermatological diseases; presence of active inflammatory dermatoses in the test region; frequent exposure to the sun or tanning beds; having participated in an allergenicity study within a period of less than four weeks from the start of the study; research participants with a history of allergy to the material used in the study; history of atopy; history of pathologies aggravated or triggered by ultraviolet radiation; people with immunodeficiencies; prediction of intense sun exposure or tanning session during the study period; plan to take a bath in the sea, pool or sauna during the study; research participants who practice water sports; survey participants with dermographism; use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticoids up to 2 weeks before selection; vitamin A acid treatment and/or its derivatives orally or topically up to 01 month before the beginning of the study; body aesthetic and/or dermatological treatment up to 03 weeks before selection; prediction of vaccination during the study or up to 03 weeks before the study; any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study; history of non-adherence or unwillingness to adhere to the study protocol; professionals directly involved in carrying out this protocol and their families; currently participating in another study; any condition that, in the opinion of the researcher, could compromise the study

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
t is expected not to find evidence of primary irritation, accumulated and skin sensitization, verified by means of a dermatological evaluation, based on the finding of absence of clinical signs, classified according to the scale recommended by the International Contact Dermatitis Research Group - ICDRG - (FISHER, 1995)

Secondary Outcome Measures

Name	Time	Method
o secondary outcomes expected