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A multi-centre, blinded, randomised, placebo-controlled, laboratory-based study of MQX-503, a novel topical gel formulation of nitroglycerine, in patients with Raynaud phenomenon
  1. Laura K Hummers1,
  2. Carin E Dugowson2,
  3. Frederick J Dechow3,
  4. Robert A Wise1,
  5. Jeffrey Gregory4,
  6. Joel Michalek5,
  7. Gayane Yenokyan6,
  8. John McGready6,
  9. Fredrick M Wigley1
  1. 1Department of Medicine, Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  2. 2Department of Medicine, Division of Rheumatology, University of Washington, Seattle, Washington, USA
  3. 3MediQuest Therapeutics, Inc., Bothell, Washington, USA
  4. 4Acucela Inc, Seattle Washington, USA
  5. 5Department of Epidemiology and Biostatistics, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA
  6. 6Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, Maryland, USA
  1. Correspondence to Dr Laura Kathleen Hummers, Division of Rheumatology, Johns Hopkins University, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA; lhummers{at}jhmi.edu

Abstract

Objective MQX-503 is a novel nitroglycerine preparation designed to absorb quickly and allow local vasodilatation in the skin. We examined the efficacy and tolerability of this medication in Raynaud phenomenon (RP) in a laboratory-based study.

Methods In this multi-centre, double-blind, randomised, placebo-controlled, cross-over study, subjects were treated with 0.5% or 1.25% nitroglycerine or placebo gel. Subjects received each dose twice in a randomised order. Each study session consisted of baseline laser Doppler measurements, study gel application and 5 min of cold chamber exposure (−20°C). Blood flow (BF) was measured at the end of exposure and for the next 120 min at set intervals. Other outcome measures included achievement of baseline BF; the time to achieve 50% and 70% baseline skin temperature (ST); and pain, tingling and numbness scores.

Results 37 subjects completed 214 treatment periods. Time to achieve baseline BF was significantly shorter in the two treated groups (HR=1.77 and 2.02 for 0.5% and 1.25% vs placebo, respectively). The proportion of subjects achieving baseline BF was 45.8% for placebo, 66.2% for 0.5% and 69% for 1.25% (p=0.01 and p=0.002 for 0.5% and 1.25% vs placebo, respectively). No meaningful differences were seen in ST or pain/numbness/tingling scores. Treatment was well tolerated with no serious adverse events.

Conclusions Treatment with MQX-503 caused a significant improvement in skin BF compared with placebo. Data from this proof of concept study suggest benefit of MQX-503 in subjects with RP.

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