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NCT01740934 Clinical Trial

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

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01740934
Other study ID # RCP-012
Secondary ID
Status Completed
Phase N/A
First received November 30, 2012
Last updated October 29, 2015
Start date November 2012
Est. completion date August 2013

Study information
Verified date October 2015
Source Rock Creek Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 117
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 70 Years
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Other:
• Anatabloc Cream
subject will apply active cream topically, twice per day according to instructions
• Placebo Cream
subject will apply placebo cream topically, twice per day according to instructions

Locations
Country Name City State
United States Susan H. Weinkle, MD Bradenton Florida
United States Lupo Center for Aesthetic & General Dermatology New Orleans Louisiana
United States Diane Berson, MD New York New York

Sponsors (1)
Lead Sponsor Collaborator
Rock Creek Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Change in the appearance of the facial skin Change measured by comparison of questionnaire and rating scores over time 8 to 16 weeks No
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