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

October 29, 2015 updated by: Rock Creek Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34209
        • Susan H. Weinkle, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70124
        • Lupo Center for Aesthetic & General Dermatology
    • New York
      • New York, New York, United States, 10022
        • Diane Berson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anatabloc Cream
Twice daily use of active facial cream
Other: Anatabloc Cream
subject will apply active cream topically, twice per day according to instructions
Placebo Comparator: Placebo Cream
Twice daily use of placebo facial cream
Other: Placebo Cream
subject will apply placebo cream topically, twice per day according to instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Effects
Time Frame: 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
8 to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the appearance of the facial skin
Time Frame: 8 to 16 weeks
Change measured by comparison of questionnaire and rating scores over time
8 to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rock Creek Pharmaceuticals, Inc.

Investigators

  • Study Director: M Varga, MD, Star Scientific

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCP-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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