None listed
Conditions
Brief 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
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 areas twice daily for 7 days. A 14-day safety and efficacy assessment period will follow the treatment period.
Sponsors
Neosil Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed