A Novel Oral Natural Extract for the Treatment of Senile... | NCT01183910

Studies
A Novel Oral Natural Extract for the Treatment of Senile Purpura

NCT01183910

Sponsor

Nexgen Dermatologics, Inc.

Status

Unknown status

Last Update Posted

Jun 8, 2011Estimated

Enrollment

75Estimated

Phase

Not Applicable

Conditions

PURPURA

Interventions

Citrus Bioflavanoid Blend
Calcium Carbonate

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jul 2011Estimated

Completion Date

Aug 2011Estimated

First Submitted Date

Aug 16, 2010

First Submission Date that Met QC Criteria

Aug 17, 2010

First Posted Date

Aug 18, 2010Estimated

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

Jun 6, 2011

Last Update Posted Date

Jun 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A randomized, double-blind, placebo controlled study to assess the safety and effectiveness of a novel oral natural extract to improve the appearance of the skin of patients with senile purpura.

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

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Calcium carbonate placebo pill	Placebo Comparator	Placebo medication to treat the appearance of the skin in patients with senile purpura	Dietary Supplement: Calcium Carbonate
Nutraceutical	Active Comparator	Patients take a novel, natural nutraceutical product to improve the appearance of the skin of patients with senile purpura	Dietary Supplement: Citrus Bioflavanoid Blend

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Citrus Bioflavanoid Blend	Dietary Supplement	Pill Taken Twice a Day	Nutraceutical

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA		6 WEEKS

Secondary Outcomes

Measure	Description	Time Frame
ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION		6 WEEKS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with evidence of purpura on physical exam

Exclusion Criteria:

Preexisting condition that would not allow the patients to take oral calcium supplement

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JOSHUA M BERLIN, MD	STUDY PROTOCOL, INC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Berlin Center of Medical Aesthetics		Boynton Beach	Florida	33437	United States

Condition Browse Module

MeSH Terms

ID	Term
D011693	Purpura

Ancestor Terms

ID	Term
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006470	Hemorrhage

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002119	Calcium Carbonate

Ancestor Terms

ID	Term
D017610	Calcium Compounds
D007287	Inorganic Chemicals
D002254	Carbonates
D002255	Carbonic Acid

Browse Leaves

Not provided

Browse Branches

Not provided