Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Rare Diseases

Neoplasm Metastasis

Sclerosis

Scleroderma, Systemic

Scleroderma, Diffuse

Raynaud Disease

Neoplastic Processes

Connective Tissue Diseases

Skin Diseases

Vascular Diseases

Livedoid Vasculopathy

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Embolism

Embolism and Thrombosis

Peripheral Arterial Disease

Peripheral Vascular Diseases

Skin Diseases, Vascular

Systemic Scleroderma

Acute Graft Versus Host Disease

Vasodilator Agents

Platelet Aggregation Inhibitors

Urological Agents

All Drugs and Chemicals

Alprostadil

300 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration

1000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration

3000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, two dispensers for each administration

Placebo

Barbara Troupin, MD, MBA

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).

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

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)

NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

Patients of this group will receive 2,4 mg of pl-vegf165 administered by intramuscular injection which is given in the hand

Patients of this group will receive standard therapy accepted in a clinical centre

Neovasculgen is an original gene construction that contains supercoiled plasmid DNA (1.2 mg) that encodes pCMV-vegf165 as the active substance. The drug will be supplied to the study centre as a sterile lyophilisate that will be then dissolved in 2 ml of water for injections immediately prior to administration. The drug will be administered intramuscularly (interosseous muscles of hand) at 4-5 injection sites in the dorsal surface of the hand.

Neovasculgen

Igor Plaksa

The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of digital ulcers related to secondary Raynaud's phenomenon associated with systemic scleroderma

This is a randomized, open, comparing clinical trial assessing the therapeutic efficacy of pl-vegf165 (Neovasculgen) in treating scleroderma-associated Raynaud's syndrome. Each patient of clinical group will undergo several intramuscular injections with a treatment dose of pl-vegf165 (Neovasculgen) in hand where digital ulcers locate. In the control group patients will receive only standard of care without gene therapy drug.

Study participants at the first study visit will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive capillaroscopy. After this initial assessment, the patients of clinical group will undergo intramuscular injections of pl-vegf165 (Neovasculgen) in a hand altered with digital ulcers.

Patient will report the severity of their Raynaud's symptoms weekly over the six month study period. At three month post-injection, the patient will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive capillaroscopy. At six months post-injection, the patient will again complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive capillaroscopy.

Safety and Efficacy Study of Gene Therapy Drug (Neovasculgen) to Treat Secondary Raynaud's Phenomenon

Safety and Efficacy Study of Pl-vegf165 to Treat Secondary Raynaud's Phenomenon Caused by Systemic Scleroderma

To determine the ability of pl-vegf165 to prevent development of new digital ulcers the frequency of new digital ulcers will be measured in both groups and then compared

The ability of pl-vegf165 to accelerate the healing of the digital ulcer will be measured by estimating the area of the defect in progress

Visual analog scale is a diagnostic tool providing an assessment of the severity and quality of pain experienced by patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis	NCT02228850	Raynaud's Pheno...	Alprostadil Placebo	18 Years - 79 Years	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis	NCT02228850	Raynaud's Pheno...	Alprostadil Placebo	18 Years - 79 Years	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Safety and Efficacy Study of Gene Therapy Drug (Neovasculgen) to Treat Secondary Raynaud's Phenomenon	NCT02356809	Secondary Rayna...	Neovasculgen	18 Years - 65 Years	Human Stem Cell Institute, Russia

Spots Global Cancer Trial Database for secondary raynaud's phenomenon