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NCT01183910 Clinical Trial

A Novel Oral Natural Extract for the Treatment of Senile Purpura

PURPURA Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01183910
Other study ID # 021775
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 16, 2010
Last updated June 6, 2011
Start date November 2008
Est. completion date August 2011

Study information
Verified date June 2011
Source Nexgen Dermatologics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 75
Est. completion date August 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Citrus Bioflavanoid Blend
Pill Taken Twice a Day
• Calcium Carbonate
Oral Tablet Taken Twice a Day

Locations
Country Name City State
United States Berlin Center of Medical Aesthetics Boynton Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Nexgen Dermatologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA 6 WEEKS No
Secondary ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION 6 WEEKS Yes
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