- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05876546
Evaluation of Skin Irritancy and Sensitization of a Liquid Bandage
Assessment of the Primary, Accumulated Irritability and Skin Sensitization Potential of an Elastic Collodion-based Liquid Bandage Under Controlled and Maximized Conditions (RIPT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natalia Gianni
- Phone Number: 41449500
- Email: natalia.gianni@eurofarma.com
Study Contact Backup
- Name: Edilene Macedo
- Phone Number: 1150908600
- Email: edilene.macedo@eurofarma.com
Study Locations
-
-
-
São Paulo, Brazil, 06696-000
- Eurofarma Laboratorios S.A
-
Contact:
- Edilene Macedo
- Phone Number: 1150908600
- Email: edilene.macedo@eurofarma.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liquid bandage
liquid bandage - The liquid bandage will be distributed on a contact test filter paper disc, appropriately identified, in the letter of the alphabet corresponding to the experimental product.
|
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.
|
Sham Comparator: Saline Solution
saline solution - The sterile saline solution (NaCl 0.9%) will be used as control in another contact test filter paper disc, appropriately identified, in the letter of the alphabet corresponding to the control.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prove the absence of primary irritability potential of the experimental product under maximized conditions.
Time Frame: 6 weeks
|
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EF184A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Skin Care
-
Revision SkincareStephens & Associates, Inc.CompletedSkin Care | Photodamaged SkinUnited States
-
LycoRed Ltd.CompletedSkin CareUnited States
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
Power Life Sciences Inc.Not yet recruiting
-
Wayne State UniversityCompletedSkin CareUnited States
-
Marmara UniversityRecruiting
-
Eurofarma Laboratorios S.A.Not yet recruiting
-
Sakarya UniversityCompleted
Clinical Trials on Liquid bandage
-
Federal University of São PauloTerminated
-
Eurofarma Laboratorios S.A.Not yet recruiting
-
Medical University of ViennaOutcomes Research ConsortiumTerminated
-
University Hospital, ToulouseRecruiting
-
Universidade Norte do ParanáCompleted
-
Johnson & Johnson Consumer Inc. (J&JCI)CompletedWound HealingUnited States
-
Goldman, Butterwick, Fitzpatrick and GroffCompletedExposure LaserUnited States
-
University of AlcalaCompleted
-
Instituto Nacional de Cancer, BrazilNot yet recruiting
-
Hospital Clinic of BarcelonaCompleted