A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea

Not Applicable

Completed

• Conditions: Rosacea
• Interventions: Other: Placebo Cream; Other: Anatabloc Cream

• Registration Number: NCT01740934
• Lead Sponsor: Rock Creek Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Cream	Placebo Cream	Twice daily use of placebo facial cream
Anatabloc Cream	Anatabloc Cream	Twice daily use of active facial cream

Primary Outcome Measures

Name	Time	Method
Adverse Effects	8 to 16 weeks	Collected information of the safety, tolerability and adverse events, and subjective experience related to the use of Anatabloc Cream by subjects

Secondary Outcome Measures

Name	Time	Method
Change in the appearance of the facial skin	8 to 16 weeks	Change measured by comparison of questionnaire and rating scores over time

Trial Locations

Locations (3)

Susan H. Weinkle, MD; 🇺🇸 Bradenton, Florida, United States

Lupo Center for Aesthetic & General Dermatology; 🇺🇸 New Orleans, Louisiana, United States

Diane Berson, MD; 🇺🇸 New York, New York, United States