Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Novel Oral Natural Extract for the Treatment of Senile Purpura

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01183910
Recruitment Status : Unknown
Verified June 2011 by Nexgen Dermatologics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 18, 2010
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Nexgen Dermatologics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
PURPURA Dietary Supplement: Citrus Bioflavanoid Blend Dietary Supplement: Calcium Carbonate Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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
Study Start Date : November 2008
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA [ Time Frame: 6 WEEKS ]

Secondary Outcome Measures :
  1. ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION [ Time Frame: 6 WEEKS ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183910


Locations
Layout table for location information
United States, Florida
Berlin Center of Medical Aesthetics
Boynton Beach, Florida, United States, 33437
Sponsors and Collaborators
Nexgen Dermatologics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: JOSHUA M BERLIN, MD STUDY PROTOCOL, INC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: GARY BERLIN, ESQUIRE, NEXGEN DERMATOLOGICS, INC.
ClinicalTrials.gov Identifier: NCT01183910    
Other Study ID Numbers: 021775
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Keywords provided by Nexgen Dermatologics, Inc.:
PURPURA
SENILE PURPURA
BATEMAN'S PURPURA
Additional relevant MeSH terms:
Layout table for MeSH terms
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Calcium Carbonate
 Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents