Metronidazole Ointment in Non-healing Pilonidal Sinus Wounds

NCT04273997 | Unknown Phase 2

• 1 other identifier: MET-PS-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Title of Study: Randomised, double-blind, placebo-controlled trial evaluating the effects of metronidazole ointment in facilitating resolution on non-healing pilonidal sinus wounds Medical Condition Under Investigation Non-healing pilonidal sinus wounds Study centres: 2 Centres in Turkey Clinical Phase: Phase 2 Protocol Number: MET-PS-02 Study Design: Randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of metronidazole ointment applied to the wound, following debridement in non-healing pilonidal sinus wounds. Planned Sample Size: 80 subjects

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with complete healing by Week 6.

  Proportion of subjects treated with Metronidazole ointment to placebo with complete healing by Week 6.

  6 weeks

Secondary Outcomes (6)

• Determine the effects of Metronidazole ointment on the time course of healing • Determine the effects of metronidazole in promoting partial healing

  2-6 weeks

• Subjects with complete healing by weeks 2 and 4

  2-4 weeks

• Maintaining of complete healing over consecutive visits

  2-6 weeks

• response time for complete healing

  2-6 weeks

• PUSH score change

  weeks 2, 4 and 6

Study Arms (2)

Metronidazole Ointment

ACTIVE COMPARATOR

Treatment Group A: Metronidazole 10% w/w ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily. One dose contains approximately 70 mg metronidazole in a formulation of white soft paraffin. The Investigator will demonstrate to the subject how to apply a 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of IMP to ensure sufficient cover of the wound

Drug: Metronidazole 10% ointment

Placebo Ointment

PLACEBO COMPARATOR

Treatment Group B: Placebo ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily. One dose of placebo ointment contains titanium dioxide and white soft paraffin. The Investigator will demonstrate to the subject how to apply a 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of IMP to ensure sufficient cover of the wound.

Drug: Placebo ointment

Interventions

Metronidazole 10% ointment DRUG

Metronidazole 10% ointment

Also known as: Ortem

Metronidazole Ointment

Placebo ointment DRUG

Placebo ointment

Placebo Ointment

Eligibility Criteria

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

You may qualify if:

• Must give written informed consent.
• Male or female aged ≥18 years.
• Previous surgery for pilonidal disease and failure of healing for ≥ 6 weeks post-surgical excision of the pilonidal cyst/sinus;
• Willingness to stop all other concomitant topical preparations at the site of pilonidal sinus wounds.

You may not qualify if:

• The subject will be excluded from the study if any of the following applies:
• Presence of non-drained abscess (abscess must have been drained ≥ 6 weeks prior to entry).
• Subjects who are due to undergo surgery related to pilonidal sinus.
• Previous use (in the last 2 weeks) or current treatment with any antibiotic. To be determined by medical history prior to screening.
• Previous treatment with topical metronidazole for pilonidal sinus.
• Known allergic reaction to metronidazole.
• Known allergic reaction to excipients of IMP and placebo.
• Subject is taking any prohibited medication (warfarin-type anticoagulants, fluorouracil, glucocorticoids, other topical preparations to the area of the wound, lithium, cyclosporin and disulfiram).
• Experimental agents must have been discontinued at least 8 weeks prior to screening or for a period equivalent to 5 half-lives of the agent (whichever is longer).
• History of epilepsy or seizures.
• Subject has hepatic insufficiency as defined by laboratory values outside the normal ranges.
• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless surgically sterile must use effective contraception (either combined oestrogen and progestogen containing hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, transdermal\], progestogen only hormonal contraception associated with inhibition of ovulation \[oral, injectable, implantable\], intrauterine device \[IUD\], intrauterine hormone-releasing system \[IUS\], vasectomised partner, sexual abstinence (only considered an acceptable method of contraception when it is in line with the subjects' usual and preferred lifestyle), combination of male condom with either cap, diaphragm or sponge with spermicide \[double barrier methods\]), and willing and able to continue contraception for 1 month after the last administration of IMP. Women using oral contraception must have started using it at least 2 months prior to screening. Women are not considered to be of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels that have been confirmed to be in the "postmenopausal range". Or have had a surgical bilateral oophorectomy (with or without hysterectomy) or bilateral tubal ligation at least six weeks before the screening visit. In case of oophorectomy alone, the reproductive status of the woman should have been confirmed by follow up hormone level assessment.
• Women who are pregnant or breastfeeding at baseline.
• Subjects with concurrent disease considered by the Investigator to be clinically significant in the context of the study.
• Subjects who have clinically significant abnormalities on their screening blood tests. "Clinically significant" will be determined by the surgeon at the study site.

Sponsors & Collaborators

• S.L.A. Pharma AG: lead

Study Sites (2)

Erzincan Binali Yıldırım University General Surgery Clinic

Erzincan, 24100, Turkey (Türkiye)

Location

Samsun Training and Research Hospital General Surgery Clinic

Samsun, 55200, Turkey (Türkiye)

Location

Related Publications (6)

• Akinci OF, Bozer M, Uzunkoy A, Duzgun SA, Coskun A. Incidence and aetiological factors in pilonidal sinus among Turkish soldiers. Eur J Surg. 1999 Apr;165(4):339-42. doi: 10.1080/110241599750006875.

  PMID: 10365835 BACKGROUND

• Ala S, Saeedi M, Eshghi F, Mirzabeygi P. Topical metronidazole can reduce pain after surgery and pain on defecation in postoperative hemorrhoidectomy. Dis Colon Rectum. 2008 Feb;51(2):235-8. doi: 10.1007/s10350-007-9174-3. Epub 2008 Jan 4.

  PMID: 18176825 BACKGROUND

• Maeda Y, Ng SC, Durdey P, Burt C, Torkington J, Rao PK, Mayberry J, Moshkovska T, Stone CD, Carapeti E, Vaizey CJ; Topical Metronidazole in Perianal Crohn's Study Group. Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease. Br J Surg. 2010 Sep;97(9):1340-7. doi: 10.1002/bjs.7121.

  PMID: 20632322 BACKGROUND

• Saidy M, Ali A, Adewole A, Ambroze W, Schertzer M, King E, Armstrong D. (2016) Treatment of non-healing pilonidal disease using topical 10% metronidazole: a 10-year review. Annual scientific meeting American Society Colon and Rectal surgeon (ASCRS), April 30-May 4, Los Angeles, USA.

  BACKGROUND

• Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.

  PMID: 7745322 BACKGROUND

• Ypsilantis E, Carapeti E, Chan S. The use of topical 10% metronidazole in the treatment of non-healing pilonidal sinus wounds after surgery. Int J Colorectal Dis. 2016 Mar;31(3):765-7. doi: 10.1007/s00384-015-2269-8. Epub 2015 May 24. No abstract available.

  PMID: 26003119 BACKGROUND

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Metronidazole; Ointments

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Arda Isik

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

• Ozan Kucuk

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Slagel

CONTACT

+44 (0) 1923 681 001; jslagel@slapharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, double-blind, placebo-controlled trial evaluating the effects of metronidazole ointment in facilitating resolution of non-healing pilonidal sinus wounds

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 18, 2020
• Study Start: October 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)