Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metronidazole Ointment in Non-healing Pilonidal Sinus Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04273997
Recruitment Status : Not yet recruiting
First Posted : February 18, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
S.L.A. Pharma AG

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


Condition or disease Intervention/treatment Phase
Pilonidal Sinus Drug: Metronidazole 10% ointment Drug: Placebo ointment Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, double-blind, placebo-controlled trial evaluating the effects of metronidazole ointment in facilitating resolution of non-healing pilonidal sinus wounds
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double blinded
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Metronidazole Ointment in Facilitating Resolution of Non-healing Pilonidal Sinus Wounds.
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Metronidazole Ointment

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
Metronidazole 10% ointment
Other Name: Ortem

Placebo Comparator: Placebo Ointment

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
Placebo ointment




Primary Outcome Measures :
  1. Proportion of subjects with complete healing by Week 6. [ Time Frame: 6 weeks ]
    Proportion of subjects treated with Metronidazole ointment to placebo with complete healing by Week 6.


Secondary Outcome Measures :
  1. Determine the effects of Metronidazole ointment on the time course of healing • Determine the effects of metronidazole in promoting partial healing [ Time Frame: 2-6 weeks ]
    Rate of wound healing [(baseline mm3 - Current mm3) / baseline mm3 x 100%

  2. Subjects with complete healing by weeks 2 and 4 [ Time Frame: 2-4 weeks ]
    Proportion of subjects with complete healing by Week 2 and 4

  3. Maintaining of complete healing over consecutive visits [ Time Frame: 2-6 weeks ]
    Proportion of subjects with complete healing maintained over two consecutive visits

  4. response time for complete healing [ Time Frame: 2-6 weeks ]
    Time to response, defined as complete healing

  5. PUSH score change [ Time Frame: weeks 2, 4 and 6 ]
    Change from baseline in PUSH score at Weeks 2, 4 and 6

  6. Determine the effects of metronidazole on the patient's global impression of improvement [ Time Frame: weeks 2, 4 and 6 ]
    Patient's Global Impression of Improvement (PGI-I) at Weeks 2, 4 and 6



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion criteria:

The subject will be excluded from the study if any of the following applies:

  1. Presence of non-drained abscess (abscess must have been drained ≥ 6 weeks prior to entry).
  2. Subjects who are due to undergo surgery related to pilonidal sinus.
  3. Previous use (in the last 2 weeks) or current treatment with any antibiotic. To be determined by medical history prior to screening.
  4. Previous treatment with topical metronidazole for pilonidal sinus.
  5. Known allergic reaction to metronidazole.
  6. Known allergic reaction to excipients of IMP and placebo.
  7. Subject is taking any prohibited medication (warfarin-type anticoagulants, fluorouracil, glucocorticoids, other topical preparations to the area of the wound, lithium, cyclosporin and disulfiram).
  8. 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).
  9. History of epilepsy or seizures.
  10. Subject has hepatic insufficiency as defined by laboratory values outside the normal ranges.
  11. 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.
  12. Women who are pregnant or breastfeeding at baseline.
  13. Subjects with concurrent disease considered by the Investigator to be clinically significant in the context of the study.
  14. Subjects who have clinically significant abnormalities on their screening blood tests. "Clinically significant" will be determined by the surgeon at the study site.
  15. Subjects who will be unavailable for the duration of the trial, deemed unable to comply with the requirements of the study protocol, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
  16. Subjects who show a 20% reduction in wound size between screening and baseline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273997


Contacts
Layout table for location contacts
Contact: Justin Slagel +44 (0) 1923 681 001 jslagel@slapharma.com

Locations
Layout table for location information
Turkey
Erzincan Binali Yıldırım University General Surgery Clinic
Erzincan, Turkey, 24100
Contact: Arda Isik, Prof.    +90 533 0580707    ardaisik@erzincan.edu.tr   
Principal Investigator: Arda Isik, Prof.         
Samsun Training and Research Hospital General Surgery Clinic
Samsun, Turkey, 55200
Contact: Ozan Kucuk, Assoc. Prof    +90 532 7626256    gultekinozan@hotmail.com   
Sponsors and Collaborators
S.L.A. Pharma AG
Investigators
Layout table for investigator information
Principal Investigator: Arda Isik Study Principal Investigator
Principal Investigator: Ozan Kucuk Study Principal Investigator
Publications:
Layout table for additonal information
Responsible Party: S.L.A. Pharma AG
ClinicalTrials.gov Identifier: NCT04273997    
Other Study ID Numbers: MET-PS-02
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pilonidal Sinus
Cysts
Neoplasms
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents