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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220202005
Enrollment
30
Registered
2022-02-02
Start date
2022-01-31
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Natural fibers from pineapple fibers are coated with polyacrylic acid combined with chlorhexidine by fluidization coating technique.
Experimental Device
Irritation study of Medical absorbent pad from pineapple fibers coat with polyacrylic acid and chlorhexidine

Sponsors

Government Pharmaceutical Organization
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
irritant 1 month after intervention Grading for irritant patch test

Secondary

MeasureTime frame
number of Irritation cases 1 month after intervention irritation cases reported outcome using physician

Countries

Thailand

Contacts

Public ContactKomgrit Eawsakul

School of medicine, Walailak University

komgrit.ea@wu.ac.th0619199938

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026