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Trial registered on ANZCTR


Registration number
ACTRN12606000424505
Ethics application status
Approved
Date submitted
16/09/2006
Date registered
3/10/2006
Date last updated
14/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Single-Center, Randomized, Placebo-Controlled, Double-Blind Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Candidate Topical Antimicrobial (NEO101) in the Reduction of Propionibacterium acnes among Healthy Young Adult Men
Scientific title
A Phase 1 Single-Center, Randomized, Placebo-Controlled, Double-Blind Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Candidate Topical Antimicrobial (NEO101) in the Reduction of Propionibacterium acnes among Healthy Young Adult Men
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Propionibacterium acnes amongst healthy volunteers 1396 0
Condition category
Condition code
Skin 1488 1488 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible subjects will be randomized to receive active treatment with 0.95% NEO101 gel which will be applied to the forehead twice daily for a total of 28 days. A 2-week follow-up period will follow the treatment period.
Intervention code [1] 1360 0
Treatment: Drugs
Comparator / control treatment
Eligible subjects will be randomized to receive vehicle-containing placebo gel, which will be applied to the forehead twice daily for a total of 28 days.
Control group
Placebo

Outcomes
Primary outcome [1] 2059 0
To evaluate the safety and tolerability of twice-daily (bid) topical application of NEO101 in healthy adult male subjects.
Timepoint [1] 2059 0
Assessed at baseline and then at each study visit (every weekday during the 28-day treatment period), and at the end of the two-week post-treatment follow-up period.
Secondary outcome [1] 3548 0
To make a preliminary evaluation of the efficacy of twice-daily (bid) topical application of NEO101 as an anti-acne preparation, by quantitative microbiologic determinations of Propionibacterium acnes levels before, during and after treatment in normal healthy adult male subjects.
Timepoint [1] 3548 0
This outcome will be measured at baseline and on a weekly basis during and immediately following the treatment period (through Study Day 29).

Eligibility
Key inclusion criteria
Sign an informed consent;- are in general good health;-do not have active acne lesions on the forehead;- are colonized with P. acnes, as demonstrated by a screening culture with a P. acnes count of >10,000/cm2 on facial skin (forehead);- have not used any form of topical or systemic antibiotics within 28 days prior to enrollment;- compliant with adequate birth control (defined).
Minimum age
18 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Have concomitant dermatologic or medical condition(s) which may interfere wtih the investigator's ability to evaluate the subject's response to the study drug;- have atopic dermatitis, active allergic rhinitis, or nasal polyps, seborrheic dermatitis or psoriasis, or any facial piercing;- have a history of hypersensitivity or allergic to parabens, sodium sulfite or any other ingredient in the vehicle formulation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The subject and assessor are blinded
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 225 0
Australia

Funding & Sponsors
Funding source category [1] 1625 0
Commercial sector/Industry
Name [1] 1625 0
Neosil, Inc.
Address [1] 1625 0
5980 Horton Street Suite 525 Emeryville, CA 94608
Country [1] 1625 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Neosil, Inc.
Address
5980 Horton Street Suite 525
Emeryville, CA 94608
Country
United States of America
Secondary sponsor category [1] 1426 0
None
Name [1] 1426 0
Not applicable
Address [1] 1426 0
Country [1] 1426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3072 0
Clive Berghofer Cancer Research Centre
Ethics committee address [1] 3072 0
Qpharm Pty Ltd, Level D, Clive Berghofer Cancer Research Centre, 300C Herston Road, Herston, QLD 4006
Ethics committee country [1] 3072 0
Australia
Date submitted for ethics approval [1] 3072 0
Approval date [1] 3072 0
24/08/2006
Ethics approval number [1] 3072 0
H0608-030T (P1010)

Summary
Brief summary
This study will evaluate the safety of a new anti-infective gel, and will also measure how well it is tolerated when applied two times a day to the forehead for 28 days.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27587 0
Address 27587 0
Country 27587 0
Phone 27587 0
Fax 27587 0
Email 27587 0
Contact person for public queries
Name 10549 0
Suzanne Elliott, Operations Manager
Address 10549 0
Q-Pharm Pty, Ltd
PO Box 78
Royal Brisbane Hospital
Brisbane
QLD 4029
Country 10549 0
Australia
Phone 10549 0
+61 7 38453644
Fax 10549 0
+61 7 38453637
Email 10549 0
s.elliott@qpharm.com.au
Contact person for scientific queries
Name 1477 0
Andria Langenberg, MD
Address 1477 0
5980 Horton Street
Suite 525
Emeryville, CA 94608
Country 1477 0
United States of America
Phone 1477 0
+1 510 5473610 x180
Fax 1477 0
+1 510 5473604
Email 1477 0
andria.langenberg@neosil.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary