A Novel Oral Natural Extract for the Treatment of Senile Purpura

June 6, 2011 updated by: Nexgen Dermatologics, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA
Time Frame: 6 WEEKS
6 WEEKS

Secondary Outcome Measures

Outcome Measure
Time Frame
ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION
Time Frame: 6 WEEKS
6 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nexgen Dermatologics, Inc.

Investigators

  • Principal Investigator: JOSHUA M BERLIN, MD, Study Protocol, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 021775

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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