A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea
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
1 other identifier
interventional
117
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 30, 2012
CompletedFirst Posted
Study publicly available on registry
December 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedNovember 2, 2015
October 1, 2015
9 months
November 30, 2012
October 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Effects
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 Outcomes (1)
Change in the appearance of the facial skin
8 to 16 weeks
Study Arms (2)
Anatabloc Cream
ACTIVE COMPARATORTwice daily use of active facial cream
Placebo Cream
PLACEBO COMPARATORTwice daily use of placebo facial cream
Interventions
subject will apply active cream topically, twice per day according to instructions
subject will apply placebo cream topically, twice per day according to instructions
Eligibility Criteria
You may qualify if:
- age between 25-70 years
- diagnosed with mild to moderate rosacea
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Susan H. Weinkle, MD
Bradenton, Florida, 34209, United States
Lupo Center for Aesthetic & General Dermatology
New Orleans, Louisiana, 70124, United States
Diane Berson, MD
New York, New York, 10022, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
M Varga, MD
Star Scientific
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2012
First Posted
December 4, 2012
Study Start
November 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
November 2, 2015
Record last verified: 2015-10