Evaluation of Skin Irritancy and Sensitization of a Liquid Dressing

Overview

Compatibility researches, carried out through patch testing, seek to prove the absence of adverse events during the application of a product for the first time on the skin. The product will be applied to the right and/or left back of the research participants for three consecutive weeks. The research participants shall come [to the research site] three times in a week for application/reading. After this "induction" period, the research participants will be at rest for at least 10 days and must return for reapplication of the investigational product that will be removed after approximately 48 hours and shall come [to the research site] to the readings. The objective of the study is to observe the effects of the application of the product on the skin and prove the non-appearance of irritability and/or allergy.

Full Title of Study: “Evaluation of the Potential for Primary, Accumulated Irritability and Skin Sensitization of a Liquid Dressing Under Controlled and Maximized Conditions”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Screening
  • Masking: Single (Outcomes Assessor)
• Study Primary Completion Date: July 30, 2023

Interventions

• Device: Liquid bandage
  • The product will be applied to the right and/or left back of the research participants for three consecutive weeks. The research participants should come [to the research site] three times in a week for application/reading. (1st to 3rd week). After this “induction” period, research participants will be at rest for at least 10 days. (4th to 5th week). They should return to reapply the investigational product that will be removed after approximately 48 hours and should come [to the research site] for the readings. (6th week) Participants will undergo a final clinical dermatological evaluation to evaluate possible signs and sensations of discomfort.
• Device: Saline Solution
  • The product will be applied to the right and/or left back of the research participants for three consecutive weeks. The research participants should come [to the research site] three times in a week for application/reading. (1st to 3rd week). After this “induction” period, research participants will be at rest for at least 10 days. (4th to 5th week). They should return to reapply the investigational product that will be removed after approximately 48 hours and should come [to the research site] for the readings. (6th week) Participants will undergo a final clinical dermatological evaluation to evaluate possible signs and sensations of discomfort.

Arms, Groups and Cohorts

• Experimental: Liquid bandage
  • liquid bandage – The liquid bandage will be distributed on a patch test filter paper disc, duly identified, in the letter of the alphabet corresponding to the Investigational Product.
• Placebo Comparator: Saline Solution
  • saline solution – The sterile saline solution (NaCl 0.9%) will be used as control in another patch test filter paper disc.

Clinical Trial Outcome Measures

Primary Measures

• Evaluation of skin irritation and sensitization in 6 weeks
  • Time Frame: 6 weeks
  • 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).

Participating in This Clinical Trial

Inclusion Criteria

1. Agreement to comply with safety guidelines to minimize the risks of COVID-19 contamination; 2. Participants vaccinated against Covid-19; 3. Healthy participants; 4. Intact skin in the test region; 5. Agreement to comply with the procedures and requirements of the test and to come the institute on the day(s) and time(s) determined for the evaluations; 6. Ability to consent their participation in the study; 7. Aged between 18 and 70 years; 8. Phototype (Fitzpatrick): I to IV; 9. Any sex. Exclusion Criteria:

1. Participants who belong to the COVID-19 risk group, i.e., with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the doctor judges as belonging to the risk group; 2. Pregnant or lactating women; 3. Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scarring, increased hairiness, large quantities of ephelides and nevus, sunburn); 4. Active dermatosis (local or disseminated) that may interfere with the study results; 5. History of allergic reactions, irritation or intense sensations of discomfort to topical products: cosmetics, health products or medicines; 6. History of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.); 7. Feeling of discomfort with temperature changes (too hot/too cold) and/or when in the air conditioning; 8. Participants with a history of allergy to the materials used in the study; 9. Participants with known allergy to acrylates; 10. History of pathologies aggravated or triggered by ultraviolet radiation; 11. Immunodeficiency carriers; 12. Intense sun exposure or tanning session up to 15 days before the initial evaluation; 13. Expected intense sun exposure or tanning session during the study period; 14. Expected to bathe in the sea, pool, or bathtub during the study; 15. Participants who practice water sports; 16. Dermographism; 17. Aesthetic and/or dermatological body treatment up to 03 weeks before selection; 18. Use of the following drugs of topical or systemic use: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids up to 2 weeks before selection or, considering deposition corticoids, the interval should be 1 month before selection; 19. Treatment with acidic vitamin A and/or its derivatives orally or topically up to 01 month before the start of the study; 20. Expected vaccination during the study or up to 03 weeks before the study; 21. Participating or having participated in another clinical trial closed less than 7 days prior to selection, in case the previous study was of acceptability in use; 22. Participating or having participated in another clinical trial closed less than 21 days before, if the previous trial was a compatibility or investigational Adverse Reaction study; 23. Any condition not mentioned above that, in the opinion of the investigator, may jeopardize the study evaluation; 24. History of lack of adherence or unwillingness to adhere to the study protocol; 25. Professionals directly involved in the implementation of this protocol and their families.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Eurofarma Laboratorios S.A.
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Contact(s)
  • Edilene Macedo, 1150908600, edilene.macedo@eurofarma.com