Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers

NCT02801305 | Completed Phase 2 DMC

• 1 other identifier: 95010111653
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Digital ulcers are one of the most prevalent complications of scleroderma (systemic sclerosis). There can be found few surveys on effect of topical agents on healing process of the ulcers. Thus, the aim of this study is to assess and compare the effects of topical diltiazem on SSc digital ulcers versus topical nitroglycerin.

Conditions

Digital Ulcer of Scleroderma

Keywords

Scleroderma; Diltiazem; Nitroglycerin; Topical

Outcome Measures

Primary Outcomes (1)

• Assessing the effect of topical diltiazem on scleroderma digital ulcers' healing process according to their site and comparing it with topical nitroglycerin

  10 months

Secondary Outcomes (6)

• To see if there is any significant difference in mean diameters of scleroderma digital ulcers between patients receiving placebo and ones treated with diltiazem gel

  6 months

• To see if the patients, receiving diltiazem gel, develop significantly less numbers of new ulcers during the study

  6 months

• To see if there is any significant difference in mean diameters of scleroderma digital ulcers between patients receiving placebo and ones treated with nitroglycerin ointment

  6 months

• To see if ones receiving nitroglycerin ointment develop significantly less numbers of new ulcers during the study

  6 months

• To see if ones receiving diltiazem gel have difference in mean diameters of ulcers and numbers of new ones with group receiving nitroglycerin ointment

  6 months

Study Arms (3)

Vaseline

PLACEBO COMPARATOR

About 60 patients will be considered to be in control group receiving vaseline ointment as the placebo applying 2 times daily on their ulcers for 8 weeks.

Drug: Vaseline

Diltiazem Gel 2%

EXPERIMENTAL

About 30 patients will receive Diltiazem Gel 2% applying 2 times daily for 8 weeks on their digital ulcers.

Drug: Diltiazem Gel 2%

Nitroglycerin Ointment 2%

EXPERIMENTAL

About 30 patients will receive nitroglycerin 2% applying 2 times daily for 8 weeks on their digital ulcers.

Drug: Nitroglycerin Ointment 2%

Interventions

Diltiazem Gel 2% DRUG

This a topical agent which will be applied on digital ulcers by scleroderma patients.

Also known as: DILTIGEL

Diltiazem Gel 2%

Nitroglycerin Ointment 2% DRUG

This a topical agent which will be applied on digital ulcers by scleroderma patients.

Also known as: NITROCARD

Nitroglycerin Ointment 2%

Vaseline DRUG

This is used as the topical placebo agent.

Vaseline

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having the criteria of LeRoy.
• Having ages between 20-70 years old
• Having at least one active digital ulcer

You may not qualify if:

• Having co-morbid diseases such as diabetes, thyroid and cardiovascular diseases
• Being smoker, opium addict or alcohol abuser
• Ones received inhaled or oral prostanoid in last 3 months, phosphodiesterase inhibitors except for intermittent treatment of erectile dysfunction in last 1 month and the ones received antibiotics 2 weeks prior to the study
• The ones with moderate to severe hepatic impairment or increase in aminotransferase levels more than 3

Sponsors & Collaborators

• Mohammad Ali Nazarinia: lead
• Shiraz University of Medical Sciences: collaborator

Study Sites (1)

Rheumatology Reseach Center, Shiraz University of Medical Sciences, Shiraz, Iran.

Shiraz, Fars, Iran

Location

Related Publications (11)

• Katsumoto TR, Whitfield ML, Connolly MK. The pathogenesis of systemic sclerosis. Annu Rev Pathol. 2011;6:509-37. doi: 10.1146/annurev-pathol-011110-130312.

  PMID: 21090968 BACKGROUND

• Korn JH, Mayes M, Matucci Cerinic M, Rainisio M, Pope J, Hachulla E, Rich E, Carpentier P, Molitor J, Seibold JR, Hsu V, Guillevin L, Chatterjee S, Peter HH, Coppock J, Herrick A, Merkel PA, Simms R, Denton CP, Furst D, Nguyen N, Gaitonde M, Black C. Digital ulcers in systemic sclerosis: prevention by treatment with bosentan, an oral endothelin receptor antagonist. Arthritis Rheum. 2004 Dec;50(12):3985-93. doi: 10.1002/art.20676.

  PMID: 15593188 BACKGROUND

• Ngcozana T, Ong V, Denton CP. Management of digital vasculopathy in systemic sclerosis: benefits of multiple courses of endothelin-1 receptor antagonists. BMJ Case Rep. 2014 Mar 28;2014:bcr2013203174. doi: 10.1136/bcr-2013-203174.

  PMID: 24682137 BACKGROUND

• Herrick AL, Gush RJ, Tully M, Jayson MI. A controlled trial of the effect of topical glyceryl trinitrate on skin blood flow and skin elasticity in scleroderma. Ann Rheum Dis. 1994 Mar;53(3):212. doi: 10.1136/ard.53.3.212-a. No abstract available.

  PMID: 8154944 BACKGROUND

• Abraham S, Steen V. Optimal management of digital ulcers in systemic sclerosis. Ther Clin Risk Manag. 2015 Jun 15;11:939-47. doi: 10.2147/TCRM.S82561. eCollection 2015.

  PMID: 26109864 BACKGROUND

• LeRoy EC, Medsger TA Jr. Criteria for the classification of early systemic sclerosis. J Rheumatol. 2001 Jul;28(7):1573-6.

  PMID: 11469464 BACKGROUND

• Anderson ME, Moore TL, Hollis S, Jayson MI, King TA, Herrick AL. Digital vascular response to topical glyceryl trinitrate, as measured by laser Doppler imaging, in primary Raynaud's phenomenon and systemic sclerosis. Rheumatology (Oxford). 2002 Mar;41(3):324-8. doi: 10.1093/rheumatology/41.3.324.

  PMID: 11934971 RESULT

• Tingey T, Shu J, Smuczek J, Pope J. Meta-analysis of healing and prevention of digital ulcers in systemic sclerosis. Arthritis Care Res (Hoboken). 2013 Sep;65(9):1460-71. doi: 10.1002/acr.22018.

  PMID: 23554239 RESULT

• Tsunoda A, Kashiwagura Y, Hirose K, Sasaki T, Kano N. Quality of life in patients with chronic anal fissure after topical treatment with diltiazem. World J Gastrointest Surg. 2012 Nov 27;4(11):251-5. doi: 10.4240/wjgs.v4.i11.251.

  PMID: 23494072 RESULT

• Bulus H, Varol N, Tas A, Coskun A. Comparison of topical isosorbide mononitrate, topical diltiazem, and their combination in the treatment of chronic anal fissure. Asian J Surg. 2013 Oct;36(4):165-9. doi: 10.1016/j.asjsur.2013.01.010. Epub 2013 Mar 6.

  PMID: 24054756 RESULT

• Ala S, Saeedi M, Hadianamrei R, Ghorbanian A. Topical diltiazem vs. topical glyceril trinitrate in the treatment of chronic anal fissure: a prospective, randomized, double-blind trial. Acta Gastroenterol Belg. 2012 Dec;75(4):438-42.

  PMID: 23402088 RESULT

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Nitroglycerin; Petrolatum

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Hydrocarbons

Study Officials

• Mohammad Ali Nazarinia, M.D.

  Shiraz Geriatric Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Rheumatology, Shiraz University of Medical Sciences, Shiraz, Iran.

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 15, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 6, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)