Ortem^TM clinical trials

Ortem^TM is currently in a Phase 2 clinical trial to assess the efficacy and safety of topical (10%) metronidazole for patients with non-healed pilonidal sinus wounds.

About the condition

In its most common presentation, pilonidal sinus arises in the hair follicles of the natal cleft of the sacrococcygeal area as an abscess or a painful, chronically discharging sinus tract. It causes considerable morbidity, with consequent restriction of daily activities and, potentially, hinders ability to work.

Two principal mechanisms underlie the condition. In the first, obstructed hair follicles become enlarged and eventually rupture, resulting in the formation of a subcutaneous abscess and, ultimately, a chronic sinus. The second mechanism is initiated by a broken hair or other foreign body becoming inserted abnormally into the skin. This provokes a foreign-body reaction and subsequent infection which results in cyst formation.

Pilonidal disease presents as a subcutaneous cyst or abscess that commonly arises in hair follicles and occurs, principally, in the natal cleft of the sacrococcygeal area. A familial history of pilonidal disease and obesity are recognised risk factors for the condition, which occurs most frequently in the second to fourth decades of life. Although the aetiology is not entirely clear, the presence of hair and other debris leads to a foreign body reaction, resulting in inflammation, infection and painful swelling.

Treatment

Treatment of pilonidal sinus involves surgical procedures to drain any abscess and excise the sinus tract. The wound is then either closed immediately, or after a delay, or it is left open, packed and allowed to heal.

A significant minority (10%) of patients fail to heal after surgery and this results in a chronic sacrococcygeal wound with consequent pain, discharge and lost productivity. Patients with non-healing wounds are faced with repeat surgery and protracted periods of greatly reduced quality of life. Currently there are limited medical or surgical options available for the management of these indolent sacrococcygeal wounds, which represents a real unmet medical need.

Pharmacological treatments such as analgesics and oral antibiotics, including metronidazole, are also used to treat the associated symptoms. However, long term use of oral metronidazole is limited by unpleasant adverse effects. The key targets for new treatments are the relief of symptoms and improved healing.

Ortem^TM, a formulation of metronidazole is currently under clinical trial to study the effect on pain relief, reduction of discharge and improves healing rates in cases of pilonidal sinus.

Metronidazole is not just an anti-microbial agent, it also has anti-inflammatory activity, and can inhibit the reactive oxygen species generated by neutrophils. Decreasing the inflammation and infection associated with pilonidal sinus, in conjunction with good wound management, can reduce pain and discharge, and promote healing.

Pilonidal disease presents as a subcutaneous cyst or abscess that commonly arises in hair follicles and occurs, principally, in the natal cleft of the sacrococcygeal area. A familial history of pilonidal disease and obesity are recognised risk factors for the condition, which occurs most frequently in the second to fourth decades of life. Although the aetiology is not entirely clear, the presence of hair and other debris leads to a foreign body reaction, resulting in inflammation, infection and painful swelling.

Our study is conducted on patients with a confirmed diagnosis of a non-healing wound following surgical intervention for pilonidal sinus, defined as being at least 6 weeks after surgery following primary intervention or post incision and drainage of an abscess following secondary intervention, and will be randomised.

69 subjects will be randomised in a 1:1:1 ratio; metronidazole ointment (10% and 20%), or placebo ointment, with once daily dosing for the treatment period.