Back to resultsA Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea
Primary Purpose
Rosacea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anatabloc Cream
Placebo Cream
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea focused on measuring rosacea, anatabine, Anatabloc, dermatology
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)
Sites / Locations
- Susan H. Weinkle, MD
- Lupo Center for Aesthetic & General Dermatology
- Diane Berson, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Anatabloc Cream
Placebo Cream
Arm Description
Twice daily use of active facial cream
Twice daily use of placebo facial cream
Outcomes
Primary Outcome Measures
Adverse Effects
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
Change measured by comparison of questionnaire and rating scores over time
Full Information
NCT ID
NCT01740934
First Posted
November 30, 2012
Last Updated
October 29, 2015
Sponsor
Rock Creek Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01740934
Brief Title
A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rock Creek Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
rosacea, anatabine, Anatabloc, dermatology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anatabloc Cream
Arm Type
Active Comparator
Arm Description
Twice daily use of active facial cream
Arm Title
Placebo Cream
Arm Type
Placebo Comparator
Arm Description
Twice daily use of placebo facial cream
Intervention Type
Other
Intervention Name(s)
Anatabloc Cream
Intervention Description
subject will apply active cream topically, twice per day according to instructions
Intervention Type
Other
Intervention Name(s)
Placebo Cream
Intervention Description
subject will apply placebo cream topically, twice per day according to instructions
Primary Outcome Measure Information:
Title
Adverse Effects
Description
Collected information of the safety, tolerability and adverse events, and subjective experience related to the use of Anatabloc Cream by subjects
Time Frame
8 to 16 weeks
Secondary Outcome Measure Information:
Title
Change in the appearance of the facial skin
Description
Change measured by comparison of questionnaire and rating scores over time
Time Frame
8 to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Varga, MD
Organizational Affiliation
Star Scientific
Official's Role
Study Director
Facility Information:
Facility Name
Susan H. Weinkle, MD
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Lupo Center for Aesthetic & General Dermatology
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Diane Berson, MD
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea
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