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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:
ClinicalTrials.gov Identifier:
NCT01183910
First Posted: August 18, 2010
Last Update Posted: June 8, 2011
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.
Information provided by:
Nexgen Dermatologics, Inc.
  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:


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

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.


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
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
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
First Submitted: August 16, 2010
First Posted: August 18, 2010
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:
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents