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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anatabloc Cream

Twice daily use of active facial cream

Group Type ACTIVE_COMPARATOR

Anatabloc Cream

Intervention Type OTHER

subject will apply active cream topically, twice per day according to instructions

Placebo Cream

Twice daily use of placebo facial cream

Group Type PLACEBO_COMPARATOR

Placebo Cream

Intervention Type OTHER

subject will apply placebo cream topically, twice per day according to instructions

Interventions

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Anatabloc Cream

subject will apply active cream topically, twice per day according to instructions

Intervention Type OTHER

Placebo Cream

subject will apply placebo cream topically, twice per day according to instructions

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes