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 Novel Oral Natural Extract for the Treatment of Senile Purpura

Sponsors

Lead sponsor: Nexgen Dermatologics, Inc.

Source Nexgen Dermatologics, Inc.
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.

Overall Status Unknown status
Start Date November 2008
Completion Date August 2011
Primary Completion Date July 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA 6 WEEKS
Secondary Outcome
Measure Time Frame
ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION 6 WEEKS
Enrollment 75
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Citrus Bioflavanoid Blend

Description: Pill Taken Twice a Day

Arm group label: Nutraceutical

Intervention type: Dietary Supplement

Intervention name: Calcium Carbonate

Description: Oral Tablet Taken Twice a Day

Arm group label: Calcium carbonate placebo pill

Eligibility

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

Gender: All

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
JOSHUA M BERLIN, MD Principal Investigator STUDY PROTOCOL, INC
Location
facility Berlin Center of Medical Aesthetics
Location Countries

United States

Verification Date

June 2011

Responsible Party

Name title: GARY BERLIN, ESQUIRE

Organization: NEXGEN DERMATOLOGICS, INC.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Calcium carbonate placebo pill

Arm group type: Placebo Comparator

Description: Placebo medication to treat the appearance of the skin in patients with senile purpura

Arm group label: Nutraceutical

Arm group type: Active Comparator

Description: Patients take a novel, natural nutraceutical product to improve the appearance of the skin of patients with senile purpura

Study Design Info

Allocation: Randomized

Intervention model: Single Group Assignment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov