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NCT05876546 | COMPLETED | Skin Care

Evaluation of Skin Irritancy and Sensitization of a Liquid Bandage
Sponsor:

Eurofarma Laboratories S.A.

Brief Summary:

The investigational product constitutes a medical device that is freely accessible to consumers and, as such, must be safe under real or reasonably foreseeable conditions of use and its safety must be tested before being placed on the market. Therefore, this study was designed to evaluate the biocompatibility of the experimental product, as provided for in legislation.

Condition or disease

Skin Care

Intervention/treatment

Liquid bandage

Saline Solution

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 88 participants
Masking : SINGLE
Primary Purpose : SCREENING
Official Title : Assessment of the Primary, Accumulated Irritability and Skin Sensitization Potential of an Elastic Collodion-based Liquid Bandage Under Controlled and Maximized Conditions (RIPT)
Actual Study Start Date : 2025-01-31
Estimated Primary Completion Date : 2025-02-28
Estimated Study Completion Date : 2025-02-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Age between 18 and 70 years old.
  • * Fitzpatrick phototype I to IV.
  • * Presence of intact skin in the test region.
  • * Agreement to comply with the study procedures and requirements and attend the institute on the days and times determined for the assessments.
  • * Signature of the Informed Consent Form (ICF) before carrying out any study procedure.
Exclusion Criteria
  • * Presence of skin marks in the test region that interfere with the assessment of possible skin reactions (for example, pigmentation disorders, vascular malformations, scars, increased hairiness, large quantities of ephelides and nevus, sunburn).
  • * Presence of active dermatosis (local or disseminated) that could interfere with the study results.
  • istory of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).
  • - History of allergic reactions, irritation or intense sensations of discomfort to topical products such as, for example, cosmetics, health products or medicines.
Evaluation of Skin Irritancy and Sensitization of a Liquid Bandage

Location Details

NCT05876546

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Brazil, São Paulo

Allergic

Campinas, São Paulo, Brazil, 13084-791

Not yet recruiting

Brazil,

Eurofarma Laboratorios S.A

São Paulo, Brazil, 06696-000