Evaluation of the antimicrobial properties of Neosalus cream when applied to human skin
| ISRCTN | ISRCTN18191379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18191379 |
| Secondary identifying numbers | 2018-001 |
- Submission date
- 28/11/2018
- Registration date
- 28/12/2018
- Last edited
- 18/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
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
Contact information
Scientific
1700 Owens street, Dermatology, 3rd floor
San Francisco
94158
United States of America
| Phone | 415 -575-0529 |
|---|---|
| ruby.ghadially@va.gov |
Study information
| Study design | Single centre, blinded, within-subject, interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Within-subject |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Phase 1 of a Two-Phase Evaluation of the Antimicrobial Properties of Various Product Formulations |
| Study hypothesis | Neosalus Cream will have antimicrobial effects when applied to human skin. |
| Ethics approval(s) | Gallatin Institutional Review Board, 20/11/2009, ref. 090426-150.0 |
| 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 |
| 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 study start date | 10/11/2009 |
| Overall study end date | 29/03/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 20 |
| Participant inclusion criteria | 1. Healthy 2. Over 18 years old |
| 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
Study participating centre
Bozeman, Montana
59715
United States of America
Sponsor information
Industry
411 S. State Street, 3rd Floor
Newton
18940
United States of America
| Phone | (973) 324-0200 |
|---|---|
| ContactUsUSA@exeltis.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 12/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in BMC dermatology (under review). |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 10/12/2018 | 10/12/2018 | No | No | |
| Results article | 22/01/2019 | 18/01/2023 | Yes | No |
Additional files
- 36025_BasicResults_10Dec18.pdf
- Uploaded 10/12/2018
Editorial Notes
18/01/2023: Removed publication and added correct publication.
17/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
