ActivePhase 2ACTRN12607000448448

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

Sponsor

Neosil Inc.

Enrollment

15 participants

Start Date

Sep 10, 2007

Study Type

Interventional

Conditions

Antimicrobial treatment of wounds

Summary

The Skin Centre Suite 5 AHC House 14 Carrara Street Benowa, Queensland 4217 Southeast Dermatology 1202 Creek Road Carina Heights, Queensland 4152 Therapeutics Goods Administration CTN Number 2007/487

Eligibility

Sex: Both males and femalesMin Age: 30 YearssMax Age: 80 Yearss

Inclusion Criteria1

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.

Exclusion Criteria1

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.

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Interventions

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 are

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.

Locations(1)

Australia

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ACTRN12607000448448