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

Phase 1

• Conditions: Antimicrobial treatment of atopic dermatitis; Skin - Dermatological conditions

• Registration Number: ACTRN12607000447459
• Lead Sponsor: eosil Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified