A Study to Evaluate the Safety, Tolerability, and Effects... | NCT01740934

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

NCT01740934

Sponsor

Rock Creek Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Nov 2, 2015Estimated

Enrollment

117Actual

Phase

Not Applicable

Conditions

Rosacea

Interventions

Anatabloc Cream
Placebo Cream

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Nov 30, 2012

First Submission Date that Met QC Criteria

Nov 30, 2012

First Posted Date

Dec 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2015

Last Update Posted Date

Nov 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anatabloc Cream	Active Comparator	Twice daily use of active facial cream	Other: Anatabloc Cream
Placebo Cream	Placebo Comparator	Twice daily use of placebo facial cream	Other: Placebo Cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anatabloc Cream	Other	subject will apply active cream topically, twice per day according to instructions	Anatabloc Cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Effects	Collected information of the safety, tolerability and adverse events, and subjective experience related to the use of Anatabloc Cream by subjects	8 to 16 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
M Varga, MD	Star Scientific	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Susan H. Weinkle, MD		Bradenton	Florida	34209	United States
Lupo Center for Aesthetic & General Dermatology

Condition Browse Module

MeSH Terms

ID	Term
D012393	Rosacea

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided