Overview

This trial is active, not recruiting.

Condition purpura
Treatments citrus bioflavanoid blend, calcium carbonate
Sponsor Nexgen Dermatologics, Inc.
Start date November 2008
End date July 2011
Trial size 75 participants
Trial identifier NCT01183910, 021775

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Arm
(Placebo Comparator)
Placebo medication to treat the appearance of the skin in patients with senile purpura
calcium carbonate
Oral Tablet Taken Twice a Day
(Active Comparator)
Patients take a novel, natural nutraceutical product to improve the appearance of the skin of patients with senile purpura
citrus bioflavanoid blend
Pill Taken Twice a Day

Primary Outcomes

Measure
IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA
time frame: 6 WEEKS

Secondary Outcomes

Measure
ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION
time frame: 6 WEEKS

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

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
Principal investigator JOSHUA M BERLIN, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Nexgen Dermatologics, Inc..