NCT01183910

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

2.7 years

First QC Date

August 16, 2010

Last Update Submit

June 6, 2011

Conditions

PURPURA

Keywords

PURPURASENILE PURPURABATEMAN'S PURPURA

Outcome Measures

Primary Outcomes (1)

  • IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA

    6 WEEKS

Secondary Outcomes (1)

  • ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION

    6 WEEKS

Study Arms (2)

Calcium carbonate placebo pill

PLACEBO COMPARATOR

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

Dietary Supplement: Calcium Carbonate

Nutraceutical

ACTIVE COMPARATOR

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

Dietary Supplement: Citrus Bioflavanoid Blend

Interventions

Citrus Bioflavanoid BlendDIETARY_SUPPLEMENT

Pill Taken Twice a Day

Nutraceutical
Calcium CarbonateDIETARY_SUPPLEMENT

Oral Tablet Taken Twice a Day

Calcium carbonate placebo pill

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with evidence of purpura on physical exam

You may not qualify if:

  • Preexisting condition that would not allow the patients to take oral calcium supplement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berlin Center of Medical Aesthetics

Boynton Beach, Florida, 33437, United States

Location

MeSH Terms

Conditions

Purpura

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • JOSHUA M BERLIN, MD

    STUDY PROTOCOL, INC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 18, 2010

Study Start

November 1, 2008

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

US(1)