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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01740934
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : November 2, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rosacea Other: Anatabloc Cream Other: Placebo Cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01740934

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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.
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Study Director: M Varga, MD Star Scientific
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Responsible Party: Rock Creek Pharmaceuticals, Inc. Identifier: NCT01740934    
Other Study ID Numbers: RCP-012
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015
Keywords provided by Rock Creek Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
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Skin Diseases