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

Cutaneous Leishmaniases Clinical Trial

— HECT-CL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03208543
• Other study ID #: HECT-CLQTA
• Status: Terminated
• Phase: Phase 3
• Start date: October 4, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2019
• Source: Medecins Sans Frontieres, Netherlands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Leishmaniases
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Device:
• HECT-CL
To evaluate the effectiveness, safety and feasibility of thermotherapy with the low cost Hand-held Exothermic Crystallization Thermotherapy pad in the treatment of cutaneous leishmaniasis in Quetta, Balochistan, Pakistan.

Locations

Country	Name	City	State
Pakistan	Mohtarma Shaheed Benazir Bhutto Hospital Quetta.	Quetta	Baluchistan

Sponsors (1)

Lead Sponsor	Collaborator
Medecins Sans Frontieres, Netherlands

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. Epub 2005 Mar 16. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the HECT-CL treatment as assessed by	The proportion of patients with complete re-epithelisation at each follow up visit associated with the HECT-CL treatment	180 days
Primary	Possible adverse effect of the HECT-CL treatment will studied by	The proportion of patients experiencing adverse effects (AEs) and serious adverse effects (SAEs) (Safety)	180 days
Primary	Ease of use of the HECT-CL treatment as assessed by	the observation of, and feedback from health providers on the ease of (re-)use of the HECT-CL (feasibility).	180 days
Primary	Acceptability of the HECT-CL treatment as assessed by	proportion of patients completing the treatment schedule in time (feasibility)	180 days
Primary	Inappropriateness of the HECT-CL treatment as assessed by	the percentage of patients (%) with lesions where HECT-CL cannot be used, (e.g. near eyes and lips, larger than 6 cm, or more than four lesions) (feasibility)	180 days
Secondary	The scars remaining after the HECT-CL treatment as assessed by	the proportion of patients with remaining scars	180 days
Secondary	The duration of the healing process as assessed by	The mean time (days) between time of start of treatment and complete re-epithelisation of the treated lesion the healing of the lesion (time-to-heal).	180 days