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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05876546
Other study ID # EF184A
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 30, 2024
Est. completion date August 30, 2024

Study information

Verified date May 2024
Source Eurofarma Laboratorios S.A.
Contact Gleyce Lima
Phone 55 11 5090 8411
Email gleyce.lima@eurofarma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date August 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Liquid bandage
The liquid bandage will be applied through a patch test to the participants' backs for 3 consecutive weeks, with 3 weekly applications. Afterwards, there will be a rest period of between 10 and 15 days. The liquid bandage will be applied again to the participants' back, in a naive area and removed after 48 hours.
Saline Solution
The saline solution will be applied via patch test to the participants' backs for 3 consecutive weeks, with 3 weekly applications. Afterwards, there will be a rest period of between 10 and 15 days. The saline solution will be applied again to the participants' back, in a naive area and removed after 48 hours.

Locations

Country Name City State
Brazil Eurofarma Laboratorios S.A São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prove the absence of primary irritability potential of the experimental product under maximized conditions. Occurrence of primary irritation;
Occurrence of accumulated irritation;
Occurrence of sensitization;
Occurrence of AEs ;
Treatment discontinuations due to AEs . It is expected that after the study period, the product will be considered safe because it does not promote a positive irritability response and skin sensitization in the study group. No statistical inference analysis will be performed. The results will be presented in the form of tables demonstrating whether or not there was a positive response of irritability or skin sensitization in the study group. During the study, the regions of the product and control application will be evaluated and if any clinical sign is found, it will be classified according to the scale recommended by the International Contact Dermatitis Research Group - ICDRG - (FISHER, 1995).
6 weeks
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