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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01740934
First received: November 30, 2012
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Rosacea
Other: Anatabloc Cream
Other: Placebo Cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rock Creek Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Adverse Effects [ Time Frame: 8 to 16 weeks ] [ Designated as safety issue: No ]
    Collected information of the safety, tolerability and adverse events, and subjective experience related to the use of Anatabloc Cream by subjects


Secondary Outcome Measures:
  • Change in the appearance of the facial skin [ Time Frame: 8 to 16 weeks ] [ Designated as safety issue: No ]
    Change measured by comparison of questionnaire and rating scores over time


Enrollment: 117
Study Start Date: November 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anatabloc Cream
Twice daily use of active facial cream
Other: Anatabloc Cream
Placebo Comparator: Placebo Cream
Twice daily use of placebo facial cream
Other: Placebo Cream

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740934

Locations
United States, Florida
Susan H. Weinkle, MD
Bradenton, Florida, United States, 34209
United States, Louisiana
Lupo Center for Aesthetic & General Dermatology
New Orleans, Louisiana, United States, 70124
United States, New York
Diane Berson, MD
New York, New York, United States, 10022
Sponsors and Collaborators
Rock Creek Pharmaceuticals, Inc.
Investigators
Study Director: M Varga, MD Star Scientific
  More Information

No publications provided

Responsible Party: Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01740934     History of Changes
Other Study ID Numbers: RCP-012
Study First Received: November 30, 2012
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rock Creek Pharmaceuticals, Inc.:
rosacea
anatabine
Anatabloc
dermatology

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014