A Novel Oral Natural Extract for the Treatment of Senile Purpura
Sponsor
Nexgen Dermatologics, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01183910
Collaborator
(none)
75
1
2
33
2.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
75 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, 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
Study Start Date
:
Nov 1, 2008
Anticipated Primary Completion Date
:
Jul 1, 2011
Anticipated Study Completion Date
:
Aug 1, 2011
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA [6 WEEKS]
Secondary Outcome Measures
- ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION [6 WEEKS]
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01183910
Other Study ID Numbers:
- 021775
First Posted:
Aug 18, 2010
Last Update Posted:
Jun 8, 2011
Last Verified:
Jun 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms: