Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02228850
• Date of registration: 20/08/2014
• Prospective Registration: Yes
• Primary sponsor: NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
• Public title: Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
• Scientific 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)
• Date of first enrolment: November 2014
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02228850
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Barbara Troupin, MD, MBA
• Affiliation: NEXMED (U.S.A.), Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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;

a. 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:

1. Intrauterine devices

2. Double barrier methods (e.g. condom or diaphragms with spermicidal gel or foam)

3. 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.

Exclusion Criteria:

- 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;

- 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.



Age minimum: 18 Years
Age maximum: 79 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Raynaud's Phenomenon Secondary to Systemic Sclerosis

Intervention(s)

Other: Placebo

Drug: Alprostadil

Primary Outcome(s)

Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. [Time Frame: One month]

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]

Secondary ID(s)

NexMed 2014-RPS-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors