Clinical trial NCT03208543: Effectiveness, Safety and Feasibility of HECT-CL, in Quetta, Pakistan
Official title: Effectiveness, Safety and Feasibility of Thermotherapy With the Hand-held Exothermic Crystallization Thermotherapy for Cutaneous Leishmaniasis (HECT-CL), Device for Cutaneous Leishmaniasis in Quetta, Pakistan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cutaneous Leishmaniases
Keywords: thermotherapy
Pakistan
Lead sponsor: Medecins Sans Frontieres, Netherlands
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 56
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients meeting inclusion criteria will be enrolled to receive seven treatment sessions with thermotherapy (HECT-CL device) and will be reassessed during follow up visits at day 15, 30, 60, 90 and 180
Primary purpose: TREATMENT

Brief summary: 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,

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Effectiveness of the HECT-CL treatment as assessed by
timeFrame: 180 days
measure: Possible adverse effect of the HECT-CL treatment will studied by
timeFrame: 180 days
measure: Ease of use of the HECT-CL treatment as assessed by
timeFrame: 180 days
measure: Acceptability of the HECT-CL treatment as assessed by
timeFrame: 180 days
measure: Inappropriateness of the HECT-CL treatment as assessed by
timeFrame: 180 days
Secondary outcomes:
measure: The scars remaining after the HECT-CL treatment as assessed by
timeFrame: 180 days
measure: The duration of the healing process as assessed by
timeFrame: 180 days
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: Mohtarma Shaheed Benazir Bhutto Hospital Quetta.
state: Baluchistan
Study officials:
affiliation: Medecins Sans Frontieres, Netherlands
name: Koert Ritmeijer, PhD
role: STUDY_DIRECTOR
References:
citation: Shah SA, Memon AA, Auwj-e-Shamim, Baqi S, Witzig R. Low-cost thermotherapy for cutaneous leishmaniasis in Sindh, Pakistan. J Pak Med Assoc. 2014 Dec;64(12):1398-404.
citation: Olliaro P, Vaillant M, Arana B, Grogl M, Modabber F, Magill A, Lapujade O, Buffet P, Alvar J. Methodology of clinical trials aimed at assessing interventions for cutaneous leishmaniasis. PLoS Negl Trop Dis. 2013;7(3):e2130. doi: 10.1371/journal.pntd.0002130. Epub 2013 Mar 21.
citation: Reithinger R, Mohsen M, Wahid M, Bismullah M, Quinnell RJ, Davies CR, Kolaczinski J, David JR. Efficacy of thermotherapy to treat cutaneous leishmaniasis caused by Leishmania tropica in Kabul, Afghanistan: a randomized, controlled trial. Clin Infect Dis. 2005 Apr 15;40(8):1148-55. doi: 10.1086/428736. Epub 2005 Mar 16.
citation: Valencia BM, Miller D, Witzig RS, Boggild AK, Llanos-Cuentas A. Novel low-cost thermotherapy for cutaneous leishmaniasis in Peru. PLoS Negl Trop Dis. 2013 May 2;7(5):e2196. doi: 10.1371/journal.pntd.0002196. Print 2013.