A Novel Oral Natural Extract for the Treatment of Senile Purpura

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2011 by Nexgen Dermatologics, Inc..
Recruitment status was: Active, not recruiting

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

Purpose

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.

Condition	Intervention
PURPURA	Dietary Supplement: Citrus Bioflavanoid Blend Dietary Supplement: Calcium Carbonate


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator)
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Calcium carbonate

U.S. FDA Resources

Further study details as provided by Nexgen Dermatologics, Inc.:

Primary Outcome Measures:

IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA [ Time Frame: 6 WEEKS ]

Secondary Outcome Measures:

ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION [ Time Frame: 6 WEEKS ]


Estimated Enrollment:	75
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Calcium carbonate placebo pill Placebo medication to treat the appearance of the skin in patients with senile purpura	Dietary Supplement: Calcium Carbonate Oral Tablet Taken Twice a Day
Active Comparator: Nutraceutical Patients take a novel, natural nutraceutical product to improve the appearance of the skin of patients with senile purpura	Dietary Supplement: Citrus Bioflavanoid Blend Pill Taken Twice a Day

Eligibility


Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183910

Locations


United States, Florida
Berlin Center of Medical Aesthetics
Boynton Beach, Florida, United States, 33437

Sponsors and Collaborators

Nexgen Dermatologics, Inc.

Investigators


Principal Investigator:	JOSHUA M BERLIN, MD	STUDY PROTOCOL, INC

More Information


Responsible Party:	GARY BERLIN, ESQUIRE, NEXGEN DERMATOLOGICS, INC.
ClinicalTrials.gov Identifier:	NCT01183910 History of Changes
Other Study ID Numbers:	021775
Study First Received:	August 16, 2010
Last Updated:	June 6, 2011

Keywords provided by Nexgen Dermatologics, Inc.:


PURPURA SENILE PURPURA BATEMAN'S PURPURA

Additional relevant MeSH terms:


Purpura Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations	Signs and Symptoms Calcium Carbonate Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 21, 2017

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