TerminatedPhase 2ACTRN12607000447459

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


Sponsor

Neosil Inc.

Enrollment

15 participants

Start Date

Sep 10, 2007

Study Type

Interventional

Conditions

Summary

The Skin Centre Suite 5 AHC House 14 Carrara Street Benowa, Queensland 4217 Therapeutic Goods Administration CTN Number 2007/490


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 50 Yearss

Inclusion Criteria1

  • 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 Criteria1

  • 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.

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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 t

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.


Locations(1)

Australia

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ACTRN12607000447459