Evaluation of Skin Irritancy and Sensitization of a Liquid Bandage

Skin Care Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05876546
• Other study ID #: EF184A
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2024
• Source: Eurofarma Laboratorios S.A.
• Contact: Edilene Macedo
• Phone: 1150908600
• Email: edilene.macedo[@]eurofarma.com
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Skin Care

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