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

MedlinePlus related topics: Calcium
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 ] [ Designated as safety issue: No ]

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

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2012