Clinical Trials List
Protocol NumberQCR19003
NCT Number(ClinicalTrials.gov Identfier)NCT
Active
2021-02-01 - 2026-12-31
Phase III
Recruiting5
A phase III, randomized, evaluator-blind, two-stage, two-way cross-over, active- and placebo-controlled, simulation study to evaluate the effectiveness and safety of Easy Antiseptic Cloth with 2% chlorhexidine gluconate (Aqua) as the topical antiseptics in healthy volunteers
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Trial Applicant
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Sponsor
Panion & BF Biotech Inc.
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 莊祐中 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林奕圻 無
- Nan-Yu Chen 無
- 陳南伃 Division of Infectious Disease
- 吳彥穆 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chien Chuang 無
- Chih Han Juan Division of Infectious Disease
- 劉思妤 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Disinfect before surgery
Objectives
The objective of this study is to evaluate the effectiveness and safety of Easy Antiseptic Cloth with 2% chlorhexidine gluconate(CHG)(Aqua) as the topical antiseptics for pre-operative skin preparation in healthy subjects.
Test Drug
Easy Antiseptic Cloth with 2% CHG(Aqua)
Active Ingredient
Chlorhexidine Gluconate
Dosage Form
Polyester cloth
Dosage
2%
Endpoints
Primary endpoints:
(1)To compare the change from baseline in bacterial count at 10 minutes post-treatment on test areas in abdominal and groin regions between the IP and placebo (superiority)
(2)To compare the change from baseline in bacterial count at 10 minutes post-treatment on test areas in abdominal and groin regions between the IP andactive control (non-inferiority)
(3)To determine the percentage of subjects whose bacterial countson test areas in abdominal and groinregions arelower than or equal to their own baselinesat 6 hours post-treatmentof IP
Secondary endpoints:
(1)To compare thechange from baseline in bacterial count at 30 seconds post-treatment on test area in abdominal region between the IP and placebo (superiority)
(2)To compare the change from baseline in bacterial count at 30 seconds post-treatment on test area in abdominal region between the IP and active control (non-inferiority)
(3)To assess the safety profile ofIP,including skin irritation,clinical laboratory test, vital signs,physical examinations,and adverse event (AE)/serious adverse event (SAE)during the study period
(1)To compare the change from baseline in bacterial count at 10 minutes post-treatment on test areas in abdominal and groin regions between the IP and placebo (superiority)
(2)To compare the change from baseline in bacterial count at 10 minutes post-treatment on test areas in abdominal and groin regions between the IP andactive control (non-inferiority)
(3)To determine the percentage of subjects whose bacterial countson test areas in abdominal and groinregions arelower than or equal to their own baselinesat 6 hours post-treatmentof IP
Secondary endpoints:
(1)To compare thechange from baseline in bacterial count at 30 seconds post-treatment on test area in abdominal region between the IP and placebo (superiority)
(2)To compare the change from baseline in bacterial count at 30 seconds post-treatment on test area in abdominal region between the IP and active control (non-inferiority)
(3)To assess the safety profile ofIP,including skin irritation,clinical laboratory test, vital signs,physical examinations,and adverse event (AE)/serious adverse event (SAE)during the study period
Inclution Criteria
Main inclusion criteria:
Subjectsenrolled in this studyshould meet all inclusion criteria:
(1)Male or female healthy volunteer aged ≥ 20 years old.
(2)Subjects with no evidence of dermatosis, dermatitis, inflammation, scarring, tattoo, open wounds, or injuries,in/around theabdominal and groinregions at the screening visit and during the study period.
(3)Subject with a conditioning baseline bacterial count ≥ 1,000 (3 log10) colony forming unit (CFU) per square centimeter (cm2) on individual side (both left and right) of abdomen.
(4)Subjectwith a conditioning baseline bacterial count ≥ 100,000 (5 log10) CFU/cm2on individual side (both left and right) of groin.
(5)Subjects with no clinically significant abnormal findings with the physical examination, vital sign, medical/medication history, or clinical laboratory results at the screening visit as judged by the investigator
(6)Female subject with childbearing potential must have a negative urinepregnancy test at the screening visit.
(7)Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measures during the study period. Effective birth control includes(at least one of the following methods should be used):(a)Intrauterinedevice (IUD) plus one barrier method;(b)Oral, implantable, or injectable contraceptives plus one barrier method; or(c)2-barrier methodsEffective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
(8)Subject must be willing to comply with all the instructions, study visits and procedures,and agree to provide the written informed consent.
Subjectsenrolled in this studyshould meet all inclusion criteria:
(1)Male or female healthy volunteer aged ≥ 20 years old.
(2)Subjects with no evidence of dermatosis, dermatitis, inflammation, scarring, tattoo, open wounds, or injuries,in/around theabdominal and groinregions at the screening visit and during the study period.
(3)Subject with a conditioning baseline bacterial count ≥ 1,000 (3 log10) colony forming unit (CFU) per square centimeter (cm2) on individual side (both left and right) of abdomen.
(4)Subjectwith a conditioning baseline bacterial count ≥ 100,000 (5 log10) CFU/cm2on individual side (both left and right) of groin.
(5)Subjects with no clinically significant abnormal findings with the physical examination, vital sign, medical/medication history, or clinical laboratory results at the screening visit as judged by the investigator
(6)Female subject with childbearing potential must have a negative urinepregnancy test at the screening visit.
(7)Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measures during the study period. Effective birth control includes(at least one of the following methods should be used):(a)Intrauterinedevice (IUD) plus one barrier method;(b)Oral, implantable, or injectable contraceptives plus one barrier method; or(c)2-barrier methodsEffective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
(8)Subject must be willing to comply with all the instructions, study visits and procedures,and agree to provide the written informed consent.
Exclusion Criteria
Main exclusion criteria:
Subjects will be excluded if they meet any of the following criteria:
(1)Subject whose test areas(abdomen and groin)have been exposed/contacted withanyCHG-containing products, antiseptic/antimicrobial/medicatedpersonalhygieneproducts or skin care productsincluding soap, shampoo, conditioner, cream, or lotion (e.g.,Savlon, IBL, Dettol, etc.),household cleaning chemicalsor personal hygiene products containing alcohol, acids, bases, chloride, or potassium iodide (such as organic solvents for cleaning, laundry detergents, fabric softener-treated clothing, etc.), within 2 weeks prior to the screening visitorVisit (V) 8that may affect the effectiveness evaluations of study products by the investigator’s discretion.
(2)Subject who had used CHG-containing products for oral use (e.g.,oral/mouth rinse) within 2 weeks prior to the screening visit.
(3)Subjectwho had a history of skin allergies,or had experienced allergies,or hypersensitive event possibly related to the usage of CHG or any of the ingredients of the study products in their lifetime.
(4)Subjectwho underwent or is planning to have any antibiotic products/treatments (including systemic, oral,or topical) within 2 weeks prior to the screening visit or during the study period.
(5)Subjectwho used any biocide treated pools, hottubs, tanning beds, sunbathe, hot waxes, or depilatories within 2 weeks prior to the screening visitorV8.
(6)Subjectwho participated in other clinical studies or received any investigational product/device within 30 days prior to the screening visitorV8.
(7)Subject with any medical condition (including diabetes mellitus or posing risks with infectious disease)that the investigator believes it may interfere with the safety of the subject or the conduct of the study.
(8)Female subject who is breast-feeding, pregnant, or planning to become pregnant.
Subjects will be excluded if they meet any of the following criteria:
(1)Subject whose test areas(abdomen and groin)have been exposed/contacted withanyCHG-containing products, antiseptic/antimicrobial/medicatedpersonalhygieneproducts or skin care productsincluding soap, shampoo, conditioner, cream, or lotion (e.g.,Savlon, IBL, Dettol, etc.),household cleaning chemicalsor personal hygiene products containing alcohol, acids, bases, chloride, or potassium iodide (such as organic solvents for cleaning, laundry detergents, fabric softener-treated clothing, etc.), within 2 weeks prior to the screening visitorVisit (V) 8that may affect the effectiveness evaluations of study products by the investigator’s discretion.
(2)Subject who had used CHG-containing products for oral use (e.g.,oral/mouth rinse) within 2 weeks prior to the screening visit.
(3)Subjectwho had a history of skin allergies,or had experienced allergies,or hypersensitive event possibly related to the usage of CHG or any of the ingredients of the study products in their lifetime.
(4)Subjectwho underwent or is planning to have any antibiotic products/treatments (including systemic, oral,or topical) within 2 weeks prior to the screening visit or during the study period.
(5)Subjectwho used any biocide treated pools, hottubs, tanning beds, sunbathe, hot waxes, or depilatories within 2 weeks prior to the screening visitorV8.
(6)Subjectwho participated in other clinical studies or received any investigational product/device within 30 days prior to the screening visitorV8.
(7)Subject with any medical condition (including diabetes mellitus or posing risks with infectious disease)that the investigator believes it may interfere with the safety of the subject or the conduct of the study.
(8)Female subject who is breast-feeding, pregnant, or planning to become pregnant.
The Estimated Number of Participants
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Taiwan
148(最多266) participants
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Global
0 participants
