Cleaning Product Causing Toxic Effect Clinical Trial
Official title:
Comparison of Antimicrobial Activity of AvenovaTM as a Sterile Skin Preparation in Humans
Verified date | January 2020 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim 1: To determine in vivo capability of AvenovaTM against common cutaneous microbial biome
on human skin
Aim 2: To compare to povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
against AvenovaTM as a sterile skin agent
Status | Completed |
Enrollment | 21 |
Est. completion date | December 20, 2019 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults age 18 and above able to provide informed consent to participate Adults attending Dr. Wendy Lee Oculoplastics Clinic Exclusion Criteria: - Adults unable to consent - Individuals who less than 18 years of age - Prisoners - Pregnant women - while these cleansing agents are used on pregnant women as standard cleansing agents, effects to fetus unknown - Patients currently using oral or topical antimicrobial agents - History of skin infection to facial injectable of surgery - Inability to tolerate cleansing procedure - Inability to sit comfortably for 15 - 30 minutes |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Bascom Palmer Eye Institute | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
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Debabov D, Noorbakhsh C, Wang L, et al. Avenova™ with Neutrox™ (pure 0.01% HOCl) compared with OTC product (0.02% HOCl). NovaBay Pharmaceuticals, Inc., Emeryville, California, USA.
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Steinsapir KD, Woodward JA. Chlorhexidine Keratitis: Safety of Chlorhexidine as a Facial Antiseptic. Dermatol Surg. 2017 Jan;43(1):1-6. doi: 10.1097/DSS.0000000000000822. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare the efficacy of Avenova to other standard of care cleansing agents: growth vs. no growth | Growth or no growth of bacteria in the thioglycollate broth will be noted for the control and each quadrant after cleansing with the 4 agents listed above. | 12 months | |
Secondary | Bacterial Identification | Positive thioglycollate samples will be cultured on blood agar plates and the bacterial species then identified. | 12 months |