Sensitization Potential Evaluation - BARZILAI

Phase 1

Terminated

• Conditions: Disturbances of skin sensation; L00-L99

• Registration Number: RBR-8sv755
• Lead Sponsor: INFAN - Indústria Química e Farmacêutica Nacional

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-03
• Study Completion: 2022-12-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Terminated
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Participants of both sexes; Age between 18 to 70 years; Phototypes: I, II, III and IV (according to an adapted Fitzpatrick scale - Annex 1); Skin of the whole test region; Agreement to obey the trial procedures and attend the clinic on the days and times
determined for medical evaluations and for application and reading of the dressings; Understand, consent and sign the Free
and Informed Consent Form (ICF).

Exclusion Criteria

Pregnancy or risk of pregnancy and / or lactation; (when women); Background atopic or allergic to health products; Use of anti-inflammatory drugs 30 days and / or immunosuppressive for up to three months before selection; Diseases that cause suppression of immunity, such as diabetes and HIV; Personal history of atopy; Intense sun exposure or tanning sessions up to 15 days before the evaluation; Prediction of intense exposure to sunlight or tanning sessions during the study period; Prediction of sea baths, pool or sauna during the study; Water sports practice during the study; Dermographism (property that has the skin of certain individuals to swell and redden in the place where it is streaked by something
relatively sharp); Use of oral or topical treatment with vitamin A acid and / or its derivatives up to 1 month before the beginning of the study; Aesthetic and / or dermatological treatment on the body within 03 weeks before selection; Vaccination scheduled during the study period or up to 03 weeks before selection; History of sensitization and irritation to a topical product; Active skin pathologies (local and / or disseminated) that may interfere with the results of the study; Use of new drugs, health products that
are not part of the participant's routine during
the study; Skin reactivity; Previous participation in studies with the
same product; Known history or suspected intolerance
to any ingredient in the study products (test or comparative products); History of lack of adherence or unwillingness to adhere to the study protocol; Other conditions considered by the
evaluating physician as reasonable for the disqualification from participation in the study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
o appearance of skin sensitivity is expected after application of the product in 85% of patients

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected