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OpenTrials
Completed

NCT Number: NCT01740934

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

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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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Susan H. Weinkle, MD, Bradenton, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Anatabloc Cream

Other

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

Placebo Cream

Other

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

Primary outcomes

  1. Adverse Effects

    Time frame: 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 outcomes

  1. Change in the appearance of the facial skin

    Time frame: 8 to 16 weeks

    Change measured by comparison of questionnaire and rating scores over time

Sponsors and collaborators

Lead sponsor

Rock Creek Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 4, 2012
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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