Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000448448
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 2 Two-Center, Randomized, Double-blind, Placebo-controlled, Paired Treatment Site Comparison Study to Evaluate the Safety and Preliminary Efficacy of a Topical Antimicrobial (NEO101) in Reduction of Wound Bioburden among Adults Treated with Curettage & Electrodessication for Superficial Basal Cell Carcinomas of the Trunk and Extremities
Scientific title
A Phase 2 Two-Center, Randomized, Double-blind, Placebo-controlled, Paired Treatment Site Comparison Study to Evaluate the Safety and Preliminary Efficacy of a Topical Antimicrobial (NEO101) in Reduction of Wound Bioburden among Adults Treated with Curettage & Electrodessication for Superficial Basal Cell Carcinomas of the Trunk and Extremities
Universal Trial Number (UTN)
Trial acronym
NEO101-CLIN-BCC001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antimicrobial treatment of wounds 2202 0
Condition category
Condition code
Skin 2322 2322 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. Treatment (blinded to treatment assignment) will be administered to paired target surface areas twice daily for 7 days. A 14-day safety and efficacy assessment period will follow the treatment period.
Intervention code [1] 1917 0
Treatment: Drugs
Comparator / control treatment
Placebo Gel
Control group
Placebo

Outcomes
Primary outcome [1] 3187 0
The primary objective of this study is to evaluate the safety and local tolerability of twice-daily topical application of NEO101 gel for 7 days in adult subjects treated with curettage and electrodessication for superficial basal cell carcinomas of the trunk and extremities.
Timepoint [1] 3187 0
Safety and local tolerability will be assessed during the 7-day treatment period and through the 14-day follow-up period. Physical examinations will be performed at Screening and on Days 1, 8 and 22.
Secondary outcome [1] 5315 0
1) To make a preliminary evaluation of the efficacy of bid topical application of NEO101 in the eradication of wound bioburden by Staphylococcus aureus, Streptococci, Proteus or Pseudomonas species, and Escherichia coli or Klebsiella species.
Timepoint [1] 5315 0
Cultures will be performed on Days 1, 2, 8 and 15

Eligibility
Key inclusion criteria
Clinical diagnosis of superficial basal cell carcinoma from each of two paired proposed treatment sites; have been treated for basal cell carcinoma with standard curettage and electrodessication (c and e) within 7 days prior to enrollment; have full-thickness epithelial defect with surface area less than or equal to 5 cm squared at the c and e site; have paired positive culture for either Staphylococcus aureus, Strepococci, Proteus species or Pseudomonas species, Escherischia coli or Klebsiella species from both proposed treatment areas in the absence of clinical evidence of tissue infection; compliant with defined birth control.
Minimum age
30 Years
Maximum age
80 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 response to treatment; have immunocompromised status; have a history of malignancy not in remission for at least 5 years excluding basal cell carcinoma; have an active intercurrent infection or poorly controlled medical condition; have used topical antibiotic or antibacterial soap between Screening Visit and Day 1; have used systemic antibiotic within 1 week prior to Day 1; have received systemic corticosteroid treatment 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 site (paired treatment sites A or B) is to be treated with NEO101, while the other site is to be treated with vehicle. Each study clinic location will be supplied with blinded numbered study drug kits and a drug dispensation list. Subjects will be randomized to treatment site using the order established on the drug dispensation list. Blinding of treatment assignment is achieved using vials distinguished by a green-colored label (to be used ONLY for Treatment Site A application) and a blue label (to be used ONLY for Treatment Site B 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 site (paired Treatment Site A or B) is to be treated with NEO101, while the other site is to be treated with vehicle. Each study clinic location will be supplied with blinded numbered study drug kits and a drug dispensation list. Subjects will be randomized to treatment site using the order established on the drug dispensation list. The randomization schedule was developed using a blocked randomization scheme, stratified for the two planned study sites.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
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] 213 0
4217
Recruitment postcode(s) [2] 214 0
4152

Funding & Sponsors
Funding source category [1] 2460 0
Commercial sector/Industry
Name [1] 2460 0
Neosil Inc
Country [1] 2460 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] 2233 0
None
Name [1] 2233 0
not applicable
Address [1] 2233 0
Country [1] 2233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4412 0
Bellberry Limited
Ethics committee address [1] 4412 0
Ethics committee country [1] 4412 0
Australia
Date submitted for ethics approval [1] 4412 0
Approval date [1] 4412 0
06/08/2007
Ethics approval number [1] 4412 0
72/07, 72/07a

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27731 0
Address 27731 0
Country 27731 0
Phone 27731 0
Fax 27731 0
Email 27731 0
Contact person for public queries
Name 11106 0
Carolyn Nicholls
Address 11106 0
The Skin Centre
Suite 5 AHC House
14 Carrara Street
Benowa QLD 4217
Country 11106 0
Australia
Phone 11106 0
+61 7 5597 7170
Fax 11106 0
+61 7 5597 7370
Email 11106 0
carolynnicholls@ozemail.com.au
Contact person for scientific queries
Name 2034 0
Andria Langenberg, MD
Address 2034 0
Neosil Inc.
Suite 525
5980 Horton Street
Emeryville California 94608
Country 2034 0
United States of America
Phone 2034 0
+1 510 547 3610, ext. 180
Fax 2034 0
+1 510 547 3604
Email 2034 0
andria.langenberg@neosil.com

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.