PURPURANCT01183910
A Novel Oral Natural Extract for the Treatment of Senile Purpura
A study testing Citrus Bioflavanoid Blend and Calcium Carbonate in people with PURPURA, run by Nexgen Dermatologics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- PURPURA
- What is being tested?
- Citrus Bioflavanoid Blend and Calcium Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with evidence of purpura on physical exam
Who cannot join
- Preexisting condition that would not allow the patients to take oral calcium supplement
Trial locations and contacts
1 site in 1 country.
United States1 site
Berlin Center of Medical Aesthetics
Boynton Beach, Florida, 33437
About this study
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
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.
- Conditions
- PURPURA
- Being tested
- Citrus Bioflavanoid Blend, Calcium Carbonate
- Keywords
- PURPURA, SENILE PURPURA, BATEMAN'S PURPURA
- Medical subject headings
- Purpura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrus Bioflavanoid BlendDietary supplement
Pill Taken Twice a Day
Calcium CarbonateDietary supplement
Oral Tablet Taken Twice a Day
| Study group | Role | What they receive |
|---|---|---|
| Calcium carbonate placebo pill | Placebo comparator | Placebo medication to treat the appearance of the skin in patients with senile purpura Receives: 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 Receives: Dietary Supplement: Citrus Bioflavanoid Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA
Measured: 6 WEEKS
Secondary outcomes (1)
ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION
Measured: 6 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startNov 2008
- Primary completionJul 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PURPURAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nexgen Dermatologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- JOSHUA M BERLIN, MD, Principal investigator, STUDY PROTOCOL, INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183910
- Sponsor's protocol ID
- 021775
- Status last verified
- Jun 2011
- First submitted
- 16 Aug 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01183910
- Acronym / sponsor ID
- 021775
- Conditions
- PURPURA
- Keywords
- PURPURA, SENILE PURPURA, BATEMAN'S PURPURA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Nexgen Dermatologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium carbonate placebo pill | Placebo comparator | Dietary Supplement: Calcium CarbonatePlacebo medication to treat the appearance of the skin in patients with senile purpura |
| Nutraceutical | Active comparator | Dietary Supplement: Citrus Bioflavanoid BlendPatients take a novel, natural nutraceutical product to improve the appearance of the skin of patients with senile purpura |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with evidence of purpura on physical exam
Key exclusion criteria (1 listed)
- Preexisting condition that would not allow the patients to take oral calcium supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citrus Bioflavanoid BlendPill Taken Twice a Day | Dietary supplement | Nutraceutical |
| Calcium CarbonateOral Tablet Taken Twice a Day | Dietary supplement | Calcium carbonate placebo pill |
Primary outcome
IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA
Time frame: 6 WEEKS
1 secondary outcome
ADVERSE EFFECTS IN PATIENTS WITH SENILE PURPURA TAKING THIS MEDICATION
Time frame: 6 WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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RecruitingPhase 3
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSHUA M BERLIN, MD principal investigator
STUDY PROTOCOL, INC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrus Bioflavanoid Blend and Calcium Carbonate in people with PURPURA, run by Nexgen Dermatologics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMPROVEMENT IN PATIENT'S SKIN APPEARANCE WITH SENILE PURPURA (time frame: 6 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.