Plain English Summary
Background and study aims
A defective skin barrier and bacterial colonization are two important factors in maintenance and progression of dry skin and eczema. The aim was to evaluate the antimicrobial efficacy of Neosalus cream.
Who can participate?
Healthy subjects at least 18 years of age of both genders who had normal skin that was free of disease and injury.
What does the study involve?
Upon completion of a 7-day product restriction period, a trained technician applied the test cream to the skin of one forearm. The other forearm received no test cream. Four sites were delineated on the skin of each forearm and, 10 minutes following the product application procedure, the sites were exposed to bacteria for contact times of 5 minutes, 10 minutes, 20 minutes, and 40 minutes. A collection liquid was then placed on the surface of the skin for one minute and then removed. The number of bacteria present in the collection liquid was then assessed in the laboratory. All participants received the same treatment.
What are the possible benefits and risks of participating?
There was nothing for the individual to gain from participating. No side effects were expected.
Where is the study run from?
The study was performed by Bioscience Laboratories, Bozeman Montana.
When is the study starting and how long is it expected to run for?
Study started 10/11/2009 – completed 29/03/2010
Who is funding the study?
Exceltis USA Dermatology
Who is the main contact?
Ruby Ghadially ruby.ghadially@ucsf.edu
Trial website
Contact information
Type
Scientific
Primary contact
Prof Ruby Ghadially
ORCID ID
Contact details
1700 Owens street
Dermatology
3rd floor
San Francisco
94158
United States of America
415 -575-0529
ruby.ghadially@va.gov
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2018-001
Study information
Scientific title
Phase 1 of a Two-Phase Evaluation of the Antimicrobial Properties of Various Product Formulations
Acronym
Study hypothesis
Neosalus Cream will have antimicrobial effects when applied to human skin.
Ethics approval
Gallatin Institutional Review Board, 20/11/2009, ref. 090426-150.0
Study design
Single centre, blinded, within-subject, interventional
Primary study design
Interventional
Secondary study design
Within-subject
Trial setting
Other
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Dry skin
Intervention
Twenty subjects, ten subjects per group, were evaluated on the forearms to determine the efficacy of Neosalus by comparing the recoveries of Escherichia coli (ATCC #11229) and Staphylococcus aureus MRSA (ATCC #33593) bacteria from the skin of treated forearms to recoveries from the skin of untreated forearms.
After a 7-day product restriction period, a trained technician applied 1ml neosalus cream to the skin of one randomly assigned forearm. The left or right forearm was randomized to treatment with the test formulation, and the remaining forearm served as the untreated control. Following demarcation (see below), the four test sites of the skin of each forearm were assigned randomly and bilaterally to post-treatment sample times.
Four sites were delineated on the skin of each forearm and, 10 minutes following the product application procedure, the sites were exposed to the randomly assigned challenges of bacterial suspensions (Staphylococcus aureus or Escherichia coli 1.0 x 10E7 CFU/ml) for contact times of 5 minutes, 10 minutes, 20 minutes, and 40 minutes, and then sampled.
On completion of testing, subjects were required to perform a I-minute rinse of their forearms with 70% ethanol and an air¬ dry, followed by a supervised 4-minute wash with a 4% chlorhexidine gluconate solution. A topical antibiotic ointment was applied to the forearms following the decontamination procedure.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Microbial counts recovered from subjects' forearms was measured using the Cylinder Sampling Technique at 5, 10, 20, and 40 minutes.
Secondary outcome measures
N/A
Overall trial start date
10/11/2009
Overall trial end date
29/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy
2. Over 18 years old
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Clinically evident dermatosis
2. Skin injury
Recruitment start date
07/12/2009
Recruitment end date
14/12/2009
Locations
Countries of recruitment
United States of America
Trial participating centre
BioScience Laboratories, Inc. (testing facility)
300 N. Willson Avenue
Bozeman, Montana
59715
United States of America
Sponsor information
Organisation
(973) 324-0200
Sponsor details
411 S. State Street
3rd Floor
Newton
18940
United States of America
(973) 324-0200
ContactUsUSA@exeltis.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Quinnova Pharmaceuticals, Inc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in BMC dermatology (under review).
IPD sharing statement: the datasets generated during and/or analysed during the current study are/will be available upon request from: Ruby Ghadially, ruby.ghadially@ucsf.edu, raw data, available by written request.
Intention to publish date
12/12/2018
Participant level data
Available on request
Basic results (scientific)
See additional file (36025_BasicResults_10Dec18.pdf)
Publication list
Publication citations
Additional files
- 36025_BasicResults_10Dec18.pdf Uploaded 10/12/2018