A Novel Oral Natural Extract for the Treatment of Senile Purpura
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Nexgen Dermatologics, Inc..
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Nexgen Dermatologics, Inc.
Information provided by:
Nexgen Dermatologics, Inc.
ClinicalTrials.gov Identifier:
NCT01183910
First received: August 16, 2010
Last updated: June 6, 2011
Last verified: June 2011
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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:
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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183910
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
| 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, Dietary Calcium Carbonate Bone Density Conservation Agents Physiological Effects of Drugs Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 28, 2016