NCT04273997 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Akinci OF, Bozer M, Uzunköy A, Düzgün SA, Coskun A
Incidence and aetiological factors in pilonidal sinus among Turkish soldiers. Eur J Surg. 1999 Apr;165(4):339-42.
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.
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.
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.
Søndenaa K, Andersen E, Nesvik I, Søreide JA
Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42.
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.

Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Metronidazole Ointment in Facilitating Resolution of Non-healing Pilonidal Sinus Wounds.

Details for clinical trial NCT04273997

Clinical trial NCT04273997 - References