Irritation study of Medical absorbent pad from pineapple fibers coat with polyacrylic acid and chlorhexidine in healthy volunteers (Clinical Trial Phase I)

Phase 1

Active, not recruiting

• Conditions: Irritation studies were conducted in healthy participants. therefore, Healthy participants had no complications in this study.; Irritation, Skin test

• Registration Number: TCTR20220202005
• Lead Sponsor: Government Pharmaceutical Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-02
• Study Completion: 2022-02-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Healthy volunteers
2. Male and female Aged between 18-50 years
3. Interview volunteers before starting the research study. The subjects had no history of allergy to chlorhexidine, such as products containing chlorhexidine in mouthwash, toothpaste, soap, cream, or a solution applied to the skin as a disinfectant. by the nature of allergic reactions such as hives, itchy rash, red swelling, difficulty breathing, swollen face, swollen lips, etc.
4. Voluntarily participate in the project after hearing a description of the research process until it is understood. and is not in the process of participating in another research project

Exclusion Criteria

1. have a skin rash Skin disease or allergic rash is a skin lesion on the back.
2. have a history of liver disease, kidney disease, blood disease or other serious disease that will affect the test
3. Taking or applying immunosuppressants or corticosteroids or other immunosuppressive drugs during the test. and did not stop taking the drug at least 2 weeks before the test
4. Pregnant women or women who wish to conceive during the research period including women who are breastfeeding
5. Have a history of allergy or allergic to plaster, micropore/microfilm.
6. Never stop applying skin care products. At least 1 week before the test
7. Volunteers with a history of allergy to rubber, banana, avocado, kiwi and pineapple.

Study & Design

• Study Type: Interventional
• Study Design: Not specified