Raynaud's Phenomenon Secondary to Systemic SclerosisPhase 2NCT02228850
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
A Phase 2 study testing Alprostadil in people with Raynaud's Phenomenon Secondary to Systemic Sclerosis, run by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Raynaud's Phenomenon Secondary to Systemic Sclerosis
- What is being tested?
- Alprostadil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2014to Dec 2015
- Phase
- Phase 2
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a diagnosis of SSc by current ACR/EULAR Classification Criteria;
- Evidence of ongoing activity of Raynaud's Phenomenon as measured by a Raynaud Condition Score of 3 or greater at Screening;
- All females of childbearing potential must have a negative serum pregnancy test;
- Females of childbearing potential must abstain from sexual activity that could result in pregnancy, or agree to use an acceptable method of contraception throughout the study period and for 30 days following dosing of the investigational study drug. Acceptable contraception includes:
- Intrauterine devices
- Double barrier methods (e.g. condom or diaphragms with spermicidal gel or foam)
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- Condom use is advised for all forms of contraception
- Must be willing and able to discontinue ongoing therapy for RP for at least 72 hours prior to each application of study medication; such drugs include calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, short-acting PDE-5i (sildenafil, vardenafil, avanafil), sympatholytics and topical or systemic nitrates;
- Must be willing and able to discontinue consumption of caffeine-containing products (e.g., beverages and over-the-counter (OTC) medications) for at least 24 hours prior to each day of study dosing;
- Must be willing and able to remove jewelry from the treated hand prior to each day of study dosing;
- Must be willing to remove nail polish and/or nail coverings from the treated hand prior to each day of study dosing;
- Must not donate blood during the study;
- Have adequate finger extension to permit application of study treatments and attachment of physiologic measuring instruments.
- Must be willing to comply with all study procedures and study visits;
- Must provide written informed consent.
Who cannot join
- BMI less than 18.5;
- Clinically significant medical abnormality or history or presence of significant neurological, hepatic, renal, endocrine, gastrointestinal, cardiovascular, pulmonary, psychiatric and/or metabolic condition as determined by the Investigator);
- Clinical diagnosis of Systemic Sclerosis in association with other rheumatologic diseases including Mixed Connective Tissue Disease;
- Clinically significant abnormal laboratory test results at screening as determined by the Investigator;
- Raynaud's Phenomenon thought to be of non-systemic sclerosis etiology;
- Peripheral or central vasculopathy other than Systemic Sclerosis;
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- History of Scleroderma renal crisis or currently being treated for hypertension, however, subjects with controlled hypertension will not be excluded;
- Active digital ulcers or rash on hand intended for study medication;
- History in the past (5) five years of autonomic neuropathy or postural hypotension;
- Upper extremity sympathectomy at any level in the 12 months prior to study;
- Tobacco smoking within six months of screening or unwillingness to avoid smoking throughout the study (e.g., cigarette, pipe, cigar, e-cigarettes) and the use of nicotine-containing products;
- Systolic Blood pressure less than 85mm/Hg;
- Prostanoid use by any route of administration within the previous six months;
- Current use of systemic or topical nitrates, endothelin receptor antagonists (e.g., bosentan) or any long-acting PDE-5 Inhibitors (e.g. tadalafil);
- Use of topical corticosteroid to the hand or fingers within 10 days of screening;
- Current use of ergot preparations, methysergide, B-adrenergic antagonists, contraceptives containing female steroid hormones, cyclosporine, clonidine, nicotine and cocaine;
- Pregnant or lactating female;
- Has known exaggerated pharmacological sensitivity or hypersensitivity to any drug similar to Alprostadil or its excipients;
- Has known hypersensitivity to nitrile;
- Involvement in any investigational drug or device study within 30 days prior to screening;
- History of non-compliance with treatment or clinic visit attendance.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Scleroderma Program - Division of Rheumatology/Dept. of Internal Medicine
Ann Arbor, Michigan, 48109
Cleveland Clinic
Cleveland, Ohio, 44195
Diagnamics, Inc.
Encinitas, California, 92024
Scleroderma Research Center - University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15261
About this study
Official title: A Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)
The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).
Read the detailed description
The purpose of this study is to evaluate the pharmacodynamic (PD) effects of topical Alprostadil on digital perfusion by laser Doppler capillary velocimetry and digital temperature recovery with thermography following standardized cold challenge and to assess the safety and tolerability of 3 doses of Alprostadil topical cream and placebo cream in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).
- Being tested
- Alprostadil, Placebo
- Keywords
- Secondary Raynaud's Phenomenon, Secondary Raynaud's Disease, Scleroderma, Raynaud's Disease secondary to systemic sclerosis, CREST, Apricus Biosciences, laser doppler, thermography
- Medical subject headings
- Raynaud Disease, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprostadilDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Alprostadil Cream (300mcg) | Experimental | 300 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration Receives: Drug: Alprostadil; Other: Placebo |
| Alprostadil Cream (1000mcg) | Experimental | 1000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration Receives: Drug: Alprostadil; Other: Placebo |
| Alprostadil Cream (3000mcg) | Experimental | 3000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, two dispensers for each administration Receives: Drug: Alprostadil; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic evaluation: digital perfusion by laser Doppler capillary velocimetry and on digital temperature recovery with thermography.
Measured: two hours (intermittently) after cold-challenge and post-dose
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud's Phenomenon Secondary to Systemic SclerosisStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Troupin, MD, MBA, Study director, NEXMED (U.S.A.), Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228850
- Sponsor's protocol ID
- NexMed 2014-RPS-001
- Status last verified
- Mar 2016
- First submitted
- 20 Aug 2014
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)
- ClinicalTrials.gov ID
- NCT02228850
- Acronym / sponsor ID
- NexMed 2014-RPS-001
- Keywords
- Secondary Raynaud's Phenomenon, Secondary Raynaud's Disease, Scleroderma, Raynaud's Disease secondary to systemic sclerosis, CREST, Apricus Biosciences, laser doppler, thermography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Aug 2014 (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.
The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).
Detailed description
The purpose of this study is to evaluate the pharmacodynamic (PD) effects of topical Alprostadil on digital perfusion by laser Doppler capillary velocimetry and digital temperature recovery with thermography following standardized cold challenge and to assess the safety and tolerability of 3 doses of Alprostadil topical cream and placebo cream in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alprostadil Cream (300mcg) | Experimental | Drug: Alprostadil, Other: Placebo300 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration |
| Alprostadil Cream (1000mcg) | Experimental | Drug: Alprostadil, Other: Placebo1000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration |
| Alprostadil Cream (3000mcg) | Experimental | Drug: Alprostadil, Other: Placebo3000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, two dispensers for each administration |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects with a diagnosis of SSc by current ACR/EULAR Classification Criteria;
- Evidence of ongoing activity of Raynaud's Phenomenon as measured by a Raynaud Condition Score of 3 or greater at Screening;
- All females of childbearing potential must have a negative serum pregnancy test;
- Must be willing and able to discontinue ongoing therapy for RP for at least 72 hours prior to each application of study medication; such drugs include calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, short-acting PDE-5i (sildenafil, vardenafil, avanafil), sympatholytics and topical or systemic nitrates;
- Must be willing and able to discontinue consumption of caffeine-containing products (e.g., beverages and over-the-counter (OTC) medications) for at least 24 hours prior to each day of study dosing;
Key exclusion criteria (21 listed)
- BMI less than 18.5;
- Clinically significant medical abnormality or history or presence of significant neurological, hepatic, renal, endocrine, gastrointestinal, cardiovascular, pulmonary, psychiatric and/or metabolic condition as determined by the Investigator);
- Clinical diagnosis of Systemic Sclerosis in association with other rheumatologic diseases including Mixed Connective Tissue Disease;
- Clinically significant abnormal laboratory test results at screening as determined by the Investigator;
- Raynaud's Phenomenon thought to be of non-systemic sclerosis etiology;
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 |
|---|---|---|
| Alprostadil | Drug | Alprostadil Cream (1000mcg), Alprostadil Cream (3000mcg), Alprostadil Cream (300mcg) |
| Placebo | Other | Alprostadil Cream (1000mcg), Alprostadil Cream (3000mcg), Alprostadil Cream (300mcg) |
Primary outcome
Pharmacodynamic evaluation: digital perfusion by laser Doppler capillary velocimetry and on digital temperature recovery with thermography.
Time frame: two hours (intermittently) after cold-challenge and post-dose
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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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.
Barbara Troupin, MD, MBA study director
NEXMED (U.S.A.), Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alprostadil in people with Raynaud's Phenomenon Secondary to Systemic Sclerosis, run by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) at 4 sites 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 15 inclusion and 21 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: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacodynamic evaluation: digital perfusion by laser Doppler capillary velocimetry and on digital temperature recovery with thermography. (time frame: two hours (intermittently) after cold-challenge and post-dose). The study lists 2 primary outcomes in all. 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 22 Mar 2016.