Evaluation of the Efficacy and Safety of a product for health, through the Evaluation of a Dermatologist and Application of Questionnaire

Not Applicable

• Conditions: Contact dermatitis; C17.800.174.255

• Registration Number: RBR-9bb2pt
• Lead Sponsor: Ipclin - Pesquisa Clínica Integrada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Age between 18 to 65 years; Female or male; Phototypes I to IV; Subjects susceptible to the appearance of wound and/or contact dermatitis; Able to follow the guidelines and reliable to respect the restrictions of the protocol.

Exclusion Criteria

Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, ephelides and nevus in large quantities, sunburn); Active dermatoses (local and disseminated) that may interfere with the results of the study; Pregnant or lactating women; History of allergic reactions, irritation or intense feelings of discomfort to topical products: cosmetics and medicines; Participants with a history of allergy to the material used in the study; History of atopy; History of conditions aggravated or triggered by ultraviolet radiation; Immunodeficiency carriers; Renal, cardiac or hepatic transplanted; Intense sun exposure or tanning session up to 15 days prior to initial assessment; Prediction of intense sun exposure or the tanning session during the period of study conduction; Forecast to take a bath, pool or sauna during the study; Participants who practice water sports; Use of the following topical systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatories, and corticosteroids up to two weeks prior to selection; Treatment with acid vitamin A and / or its derivatives orally or topically up to 01 month before the start of the study; Prediction of vaccination during the study or until 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 accomplishment of this protocol and their relatives.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in skin conditions, identified by counting of positive responses from research participants, after completing a questionnaire of appreciability and post-intervention medical evaluation.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected.