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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01740934

Enrollment

117

Registered

2012-12-04

Start date

2012-11-30

Completion date

2013-08-31

Last updated

2015-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Keywords

rosacea, anatabine, Anatabloc, dermatology

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.

Interventions

OTHERAnatabloc Cream

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

OTHERPlacebo Cream

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 70 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Change in the appearance of the facial skin	8 to 16 weeks	Change measured by comparison of questionnaire and rating scores over time

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026