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

Rock Creek Pharmaceuticals

Status: Completed

Conditions: Rosacea

Treatments: Other: Placebo Cream; Other: Anatabloc Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01740934

RCP-012

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 2 patient groups, including a placebo group

Anatabloc Cream

Active Comparator group

Description:

Twice daily use of active facial cream

Treatment:

Other: Anatabloc Cream

Placebo Cream

Placebo Comparator group

Description:

Twice daily use of placebo facial cream

Treatment:

Other: Placebo Cream