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A Novel Oral Natural Extract for the Treatment of Senile Purpura

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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
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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
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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

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Arms and Interventions
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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
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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
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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
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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
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Responsible Party: GARY BERLIN, ESQUIRE, NEXGEN DERMATOLOGICS, INC.
ClinicalTrials.gov Identifier: NCT01183910     History of Changes
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:
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
 Signs and Symptoms
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents