Condition category
Skin and Connective Tissue Diseases
Date applied
28/11/2018
Date assigned
28/12/2018
Last edited
28/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Editorial Notes