None listed
Conditions
Brief summary
The Skin Centre Suite 5 AHC House 14 Carrara Street Benowa, Queensland 4217 Therapeutic Goods Administration CTN Number 2007/490
Interventions
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.
Sponsors
Neosil Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed