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

Sponsor

Rock Creek Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01740934

Collaborator

(none)

117

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Other: Anatabloc Cream Other: Placebo Cream	N/A

Study Design

Study Type:

Interventional

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 :

Nov 1, 2012

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Adverse Effects [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

Change in the appearance of the facial skin [8 to 16 weeks]
Change measured by comparison of questionnaire and rating scores over time

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Susan H. Weinkle, MD	Bradenton	Florida	United States	34209
2	Lupo Center for Aesthetic & General Dermatology	New Orleans	Louisiana	United States	70124
3	Diane Berson, MD	New York	New York	United States	10022