A Novel Oral Natural Extract for the Treatment of Senile Purpura

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Nexgen Dermatologics, Inc.

ClinicalTrials.gov Identifier:

NCT01183910

First received: August 16, 2010

Last updated: June 6, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 16, 2010

Last Updated Date

June 6, 2011

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA [ Time Frame: 6 WEEKS ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01183910 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION [ Time Frame: 6 WEEKS ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Novel Oral Natural Extract for the Treatment of Senile Purpura

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled Study To Assess the Safety and Efficacy of a Novel Oral Natural Extract for the Treatment of Senile Purpura

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

PURPURA

Intervention ^ICMJE

Dietary Supplement: Citrus Bioflavanoid Blend
Pill Taken Twice a Day
Dietary Supplement: Calcium Carbonate
Oral Tablet Taken Twice a Day

Study Arm (s)

Placebo Comparator: Calcium carbonate placebo pill
Placebo medication to treat the appearance of the skin in patients with senile purpura

Intervention: Dietary Supplement: Calcium Carbonate
Active Comparator: Nutraceutical
Patients take a novel, natural nutraceutical product to improve the appearance of the skin of patients with senile purpura

Intervention: Dietary Supplement: Citrus Bioflavanoid Blend

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01183910

Other Study ID Numbers ^ICMJE

021775

Has Data Monitoring Committee

Yes

Responsible Party

GARY BERLIN, ESQUIRE, NEXGEN DERMATOLOGICS, INC.

Study Sponsor ^ICMJE

Nexgen Dermatologics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

JOSHUA M BERLIN, MD

STUDY PROTOCOL, INC

Information Provided By

Nexgen Dermatologics, Inc.

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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