An Eight-Week, Multi-Site, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Subjects With Rosacea Followed by an Open-Label Extension

Rock Creek Pharmaceuticals, Inc.3 sites in 1 country117 target enrollmentNovember 2012

ConditionsRosacea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rosacea
Sponsor: Rock Creek Pharmaceuticals, Inc.
Enrollment: 117
Locations: 3
Primary Endpoint: Adverse Effects
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled, parallel-group study followed by an eight-week open-label extension to evaluate the safety, tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild to moderate rosacea.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

August 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rock Creek Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•age between 25-70 years
•diagnosed with mild to moderate rosacea

Exclusion Criteria

•allergy or sensitivity to the study products or their components
•severe rosacea
•current use of glucocorticoids, anti-acne products, antibiotics, topical retinoids, or vasoactive drugs
•recent oral isotretinoin use
•current use of anatabine-containing supplements (ie. Anatabloc, Anatabloc Unflavored, CigRx)