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

Phase 3

Terminated

• Conditions: Cutaneous Leishmaniases
• Interventions: Device: HECT-CL

• Registration Number: NCT03208543
• Lead Sponsor: Medecins Sans Frontieres, Netherlands

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.

Study Timeline

• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Study Start: 2017-10-04
• Primary Completion: 2017-12-20
• Study Completion: 2017-12-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HECT-CL	HECT-CL	HECT-CL heat pack will be applied on CL lesions (50-52 degrees Celsius for 3 minutes on 7 consecutive days)

Primary Outcome Measures

Name	Time	Method
Acceptability of the HECT-CL treatment as assessed by	180 days	proportion of patients completing the treatment schedule in time (feasibility)
Effectiveness of the HECT-CL treatment as assessed by	180 days	The proportion of patients with complete re-epithelisation at each follow up visit associated with the HECT-CL treatment
Possible adverse effect of the HECT-CL treatment will studied by	180 days	The proportion of patients experiencing adverse effects (AEs) and serious adverse effects (SAEs) (Safety)
Ease of use of the HECT-CL treatment as assessed by	180 days	the observation of, and feedback from health providers on the ease of (re-)use of the HECT-CL (feasibility).
Inappropriateness of the HECT-CL treatment as assessed by	180 days	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)

Secondary Outcome Measures

Name	Time	Method
The scars remaining after the HECT-CL treatment as assessed by	180 days	the proportion of patients with remaining scars
The duration of the healing process as assessed by	180 days	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).

Trial Locations

Locations (1)

Mohtarma Shaheed Benazir Bhutto Hospital Quetta.; 🇵🇰 Quetta, Baluchistan, Pakistan