Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000447459
Ethics application status
Approved
Date submitted
22/08/2007
Date registered
31/08/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1/2 Single Center, Randomized, Double-blind, Placebo-controlled, Left-Right Comparison Study to Evaluate the Safety and Preliminary Efficacy of a Topical Antimicrobial (NEO101) in Older Adolescents and Adults with at least Moderate Atopic Dermatitis
Scientific title
A Phase 1/2 Single Center, Randomized, Double-blind, Placebo-controlled, Left-Right Comparison Study to Evaluate the Safety and Preliminary Efficacy of a Topical Antimicrobial (NEO101) in Older Adolescents and Adults with at least Moderate Atopic Dermatitis
Universal Trial Number (UTN)
Trial acronym
NEO101-CLIN-AD001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antimicrobial treatment of atopic dermatitis 2196 0
Condition category
Condition code
Skin 2344 2344 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible subjects will be randomized to receive both NEO101 0.95% gel and vehicle-containing placebo gel twice daily for 14 days. Treatment (blinded to treatment assignment) will be administered to the left and right side target skin surface areas for 14 days. A 14-day safety and efficacy assessment period will follow the treatment period.
Intervention code [1] 1911 0
Treatment: Drugs
Comparator / control treatment
Placebo Gel
Control group
Placebo

Outcomes
Primary outcome [1] 3181 0
The primary objective of this study is to evaluate the safety and local tolerability of twice-daily topical application of NEO101 gel for 14 days in subjects with a clinical diagnosis of at least moderate atopic dermatitis.
Timepoint [1] 3181 0
Safety and local tolerability will be assessed during the 14-day treatment period and through the 14-day follow-up period. Physical examinations will be performed at Screening, and on Days 1, 15 and 29.
Secondary outcome [1] 5305 0
1) To make a preliminary evaluation of the efficacy of bid topical application of NEO101 in the reduction or eradication of Staphylococcus aureus.
Timepoint [1] 5305 0
Cultures will be performed on Days 1, 2, 4, 8, 15 and 22
Secondary outcome [2] 5306 0
2) To make a preliminary evaluation of the efficacy of bid topical application of NEO101 in the reduction or eradication of other microorganisms including Streptococci and gram-negative bacteria such as Proteus or Pseudomonas.
Timepoint [2] 5306 0
Cultures will be performed on Days 1, 8 and 15.

Eligibility
Key inclusion criteria
Diagnosed with atopic dermatitis as defined by pruritus, eczmetatous dermatitis, personal or family history of atopy; have a Physician's Global Assessment score equivalent to mild-to-moderate atopic dermatitis at Screening and Day 1; have a target treatment area of 50-150 cm squared on both a left and a right side of the body; have a positive culture for Staphylococcus aureus on both target treatment areas; compliant with defined birth control.
Minimum age
16 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate subject response; have immunocompromised status; have any clinically significant abnormal clinical laboratory test results at screening; have a history of malignancy not in remission for at least 5 years excluding basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin; have an active intercurrent infection; have used any topical antibiotic or antibacterial soap or bleach baths within 72 hours prior to Day 1; have used any systemic antibiotic within 1 week prior to Day 1; have a history of hypersensitivity or allergic reactions to parabens, sodium sulfite or 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)
Once a subject is identified as eligible to be randomized into the study, he/she will be assigned a unique subject number, which will correspond to the randomization code indicating which side (left or right) is to be treated with NEO101, while the other side is to be treated with vehicle. The study site will be supplied with blinded numbered study drug kits and a drug dispensation list. Subjects will be randomized to treatment side using the order established on the drug dispensation list. Blinding of treatment assignment is achieved using vials distinguished by a yellow (lemon)-colored label (to be used ONLY for left side application) and a white label (to be used ONLY for right side application).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be assigned a unique subject number, which will correspond to the randomization code indicating which side (left or right) is to be treated with NEO101, while the other side is to be treated with vehicle. The study site will be supplied with blinded numbered study drug kits and a drug dispensation list. Subjects will be randomized to treatment side using the order established on the drug dispensation list. The randomization schedule was developed using a blocked randomization scheme.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a left-right treatment site comparison study. The investigator, study staff and subjects will be blinded.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
10/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 215 0
4217

Funding & Sponsors
Funding source category [1] 2454 0
Commercial sector/Industry
Name [1] 2454 0
Neosil Inc
Country [1] 2454 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Neosil Inc.
Address
5980 Horton Street, Suite 525
Emeryville, California 94608
Country
United States of America
Secondary sponsor category [1] 2226 0
None
Name [1] 2226 0
not applicable
Address [1] 2226 0
Country [1] 2226 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4413 0
Bellberry Limited
Ethics committee address [1] 4413 0
First Floor
71 Anzac Highway
Ashford, South Australia 5035
Ethics committee country [1] 4413 0
Australia
Date submitted for ethics approval [1] 4413 0
Approval date [1] 4413 0
26/07/2007
Ethics approval number [1] 4413 0
57/07

Summary
Brief summary
The Skin Centre
Suite 5
AHC House
14 Carrara Street
Benowa, Queensland 4217

Therapeutic Goods Administration
CTN Number 2007/490
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27725 0
Address 27725 0
Country 27725 0
Phone 27725 0
Fax 27725 0
Email 27725 0
Contact person for public queries
Name 11100 0
Carolyn Nicholls
Address 11100 0
The Skin Centre
Suite 5
AHC House
14 Carrara Street
Benowa QLD 4217
Country 11100 0
Australia
Phone 11100 0
+61 7 5597 7170
Fax 11100 0
+61 7 5597 7370
Email 11100 0
[email protected]
Contact person for scientific queries
Name 2028 0
Andria Langenberg, MD
Address 2028 0
Neosil Inc.
Suite 525
5980 Horton Street
Emeryville California 94608
Country 2028 0
United States of America
Phone 2028 0
+1 510 547 3610, ext. 180
Fax 2028 0
+1 510 547 3604
Email 2028 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.