Clinical Trials List
Protocol NumberQCR19003
Active
2021-02-01 - 2026-12-31
Phase III
Recruiting4
A phase III, randomized, assessor-blinded, two-stage, two-way crossover, active-and-placebo controlled trial was conducted to evaluate the efficacy and safety of using chlorhexidine gluconate (Aqua)-containing antibacterial wipes as a topical disinfectant in healthy volunteers.
-
Trial Applicant
-
Sponsor
Baoling Fujin Biotechnology Co., Ltd.
-
Trial scale
Taiwan Multiple Center
-
Update
2026/05/14
Investigators and Locations
Co-Principal Investigator
- 莊祐中 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉思妤 無
- Chien Chuang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Ting-Shu Wu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Hand disinfection before surgery, hand disinfection in the ward, and skin disinfection for patients before surgery.
Objectives
This study aimed to evaluate the efficacy and safety of Easy Antiseptic Cloth containing 2% chlorhexidine gluconate (CHG) (Aqua) as a topical disinfectant in preoperative skin treatment procedures in healthy subjects.
Test Drug
liniment
Active Ingredient
Chlorhexidine Gluconate
Dosage Form
374
Dosage
2
Endpoints
(1) Compare the changes in bacterial counts in the abdominal and groin areas 10 minutes after administration of IP versus placebo, compared to the baseline (after bacterial inoculation) (superiority).
(2) Compare the changes in bacterial counts in the abdominal and groin areas 10 minutes after administration of IP versus the active control, compared to the baseline (after bacterial inoculation) (non-inferiority).
(3) Measure the percentage of subjects whose bacterial counts in the abdominal and groin areas were lower than or equal to their baseline (after bacterial inoculation) values 6 hours after administration of IP.
(2) Compare the changes in bacterial counts in the abdominal and groin areas 10 minutes after administration of IP versus the active control, compared to the baseline (after bacterial inoculation) (non-inferiority).
(3) Measure the percentage of subjects whose bacterial counts in the abdominal and groin areas were lower than or equal to their baseline (after bacterial inoculation) values 6 hours after administration of IP.
Inclution Criteria
1. Key Inclusion Criteria: Participants in this trial must meet all of the following inclusion criteria:
(1) Healthy male or female volunteers aged 20 years or older.
(2) No evidence of skin disease, dermatitis, inflammation, scars, tattoos, open wounds, or injuries on or around the abdomen and groin during the screening return visit and the trial period.
(3) Baseline bacterial count per square centimeter (cm²) on each side of the abdomen (left and right) of the participant ≤ 1,000 (3 log10) CFU/cm².
(4) Baseline bacterial count per groin on each side of the participant (left and right) of the participant ≤ 100,000 (5 log10) CFU/cm².
(5) At the screening return visit, the trial administrator determined that the participant's physical examination, vital signs, medical history/medication history, or clinical laboratory test results showed no clinically significant abnormalities. (6) At the screening follow-up visit, the serum pregnancy test result of fertile female subjects must be negative.
(7) Fertility-prone female subjects must be willing to use highly effective and appropriate contraception during the trial. Effective contraception includes (at least one of the following methods should be used):
(a) Intrauterine device (IUD) plus a blocking method;
(b) Oral, implantable, or injectable contraceptive pills plus a blocking method; or
(c) Two blocking methods. Effective blocking methods are male or female condoms, diaphragms, and spermicides (creams or gels containing chemicals that kill sperm).
(8) Subjects must be willing to comply with all instructions, trial follow-up visits, and procedures, and agree to provide written subject consent.
2. Primary Exclusion Criteria: Subjects meeting any of the following criteria will be ineligible to participate in this trial:
(1) Subjects have used products containing CHG within 2 weeks prior to the screening follow-up visit.
(2) Subjects have a history of skin allergies or have experienced allergic reactions or events that may be related to the use of CHG or any ingredient in the test product. (3) The subject received or plans to receive any oral or topical antibiotic products/treatments within 2 weeks prior to the screening return visit, during the trial period.
(4) The subject used any disinfectant/medicated/antimicrobial personal hygiene products or skin care products, including soaps, shampoos, conditioners, creams, or lotions (e.g., Savlon, IBL, Dettol, etc.), which the testing physician deems may affect the effectiveness of the test product within 2 weeks prior to the screening return visit.
(5) The subject used any swimming pools, hot tubs, tanning beds, sunbathing, hot waxes, or depilatories disinfected with bactericides within 2 weeks prior to the screening return visit and during the trial period.
(6) Within 2 weeks prior to the screening return visit and during the trial period, the subject's test area (abdomen and groin) was exposed to/contacted with household chemical cleaners or personal hygiene products containing alcohol, acids, alkalis, chlorides, or potassium iodide (e.g., cleaning organic solvents, laundry detergent, fabric softener) that the testing physician deems may affect the effectiveness of the test product. (7) The subject has participated in other clinical trials or received any product/device used in any study within 30 days prior to the screening return visit.
(8) The subject has any medical condition (including diabetes or risk of infectious diseases) that the trial administrator believes may interfere with the subject's safety or the conduct of the trial.
(9) The subject is a breastfeeding, pregnant, or planning to become pregnant.
(1) Healthy male or female volunteers aged 20 years or older.
(2) No evidence of skin disease, dermatitis, inflammation, scars, tattoos, open wounds, or injuries on or around the abdomen and groin during the screening return visit and the trial period.
(3) Baseline bacterial count per square centimeter (cm²) on each side of the abdomen (left and right) of the participant ≤ 1,000 (3 log10) CFU/cm².
(4) Baseline bacterial count per groin on each side of the participant (left and right) of the participant ≤ 100,000 (5 log10) CFU/cm².
(5) At the screening return visit, the trial administrator determined that the participant's physical examination, vital signs, medical history/medication history, or clinical laboratory test results showed no clinically significant abnormalities. (6) At the screening follow-up visit, the serum pregnancy test result of fertile female subjects must be negative.
(7) Fertility-prone female subjects must be willing to use highly effective and appropriate contraception during the trial. Effective contraception includes (at least one of the following methods should be used):
(a) Intrauterine device (IUD) plus a blocking method;
(b) Oral, implantable, or injectable contraceptive pills plus a blocking method; or
(c) Two blocking methods. Effective blocking methods are male or female condoms, diaphragms, and spermicides (creams or gels containing chemicals that kill sperm).
(8) Subjects must be willing to comply with all instructions, trial follow-up visits, and procedures, and agree to provide written subject consent.
2. Primary Exclusion Criteria: Subjects meeting any of the following criteria will be ineligible to participate in this trial:
(1) Subjects have used products containing CHG within 2 weeks prior to the screening follow-up visit.
(2) Subjects have a history of skin allergies or have experienced allergic reactions or events that may be related to the use of CHG or any ingredient in the test product. (3) The subject received or plans to receive any oral or topical antibiotic products/treatments within 2 weeks prior to the screening return visit, during the trial period.
(4) The subject used any disinfectant/medicated/antimicrobial personal hygiene products or skin care products, including soaps, shampoos, conditioners, creams, or lotions (e.g., Savlon, IBL, Dettol, etc.), which the testing physician deems may affect the effectiveness of the test product within 2 weeks prior to the screening return visit.
(5) The subject used any swimming pools, hot tubs, tanning beds, sunbathing, hot waxes, or depilatories disinfected with bactericides within 2 weeks prior to the screening return visit and during the trial period.
(6) Within 2 weeks prior to the screening return visit and during the trial period, the subject's test area (abdomen and groin) was exposed to/contacted with household chemical cleaners or personal hygiene products containing alcohol, acids, alkalis, chlorides, or potassium iodide (e.g., cleaning organic solvents, laundry detergent, fabric softener) that the testing physician deems may affect the effectiveness of the test product. (7) The subject has participated in other clinical trials or received any product/device used in any study within 30 days prior to the screening return visit.
(8) The subject has any medical condition (including diabetes or risk of infectious diseases) that the trial administrator believes may interfere with the subject's safety or the conduct of the trial.
(9) The subject is a breastfeeding, pregnant, or planning to become pregnant.
Exclusion Criteria
none
The Estimated Number of Participants
-
Taiwan
266 participants
-
Global
0 participants
