Effectiveness, Safety and Feasibility of HECT-CL, in Quetta, Pakistan

Medecins Sans Frontieres, Netherlands

Status and phase

Terminated

Phase 3

Conditions

Cutaneous Leishmaniases

Treatments

Device: HECT-CL

Study type

Interventional

Funder types

Other

Identifiers

NCT03208543

HECT-CLQTA

Details and patient eligibility

About

This research studies the effect thermotherapy as treatment of Old World CL which is not invasive, non-toxic, and the short treatment. While the current standard treatment comprise daily painful injections with antimonials,

Full description

The current standard treatment for Old World CL is based on daily painful injections with antimonials, which in Pakistan requires specialised care provided in secondary level care facilities.

Apart from potential toxic side effects of these antimonials, the long treatment course, high cost and inconvenience, it may prevent patients from seeking care or completing treatment, especially women and children in the Pakistan context. Untreated cutaneous leishmaniasis may leave disfiguring scars leading to stigmatisation and (psycho) social problems. If the CL lesions/scars are located on joints they can cause problems in motion and lead to disability. At a public health level, patients with untreated CL lesions are a reservoir for further transmission of CL in the family and community.

Thermotherapy is topical, not invasive, non-toxic, and the treatment duration is only 7 days, and therefore is expected to have major benefits for patients.

Additional advantages are that the HECT-CL can be applied by lower level qualified health workers, and the costs are low (less than 3 USD) per re-usable heat pad), and therefore can be rolled out to peripheral health facilities, potentially having a major impact on access to treatment.

Enrollment

56 patients

Sex

All

Ages

10+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Patients with clinical CL symptoms for less than 6 months with the diagnosis confirmed by microscopic visualisation of Leishmania parasites in skin scrape smear.
Patients who have given written informed consent.

Exclusion criteria

Patients presenting with CL lesions located on or within two centimetres of eyes and lips.
Patients with more than four lesions.
Lesions, nodules and/or ulcerations with a diameter (ø) of more than 6 cm.
Patients with persistent lesions for more than 6 months.
Patients younger than 10 years.
Patients who are unlikely, unable or unwilling to be available for and comply to regular follow up visits for 6 months.
Pregnant, and lactating women <6 months after delivery.
Patients with uncontrolled medical illnesses.
Patients with immune disorders, such as HIV/AIDS, or those who are on steroid medication