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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208543
Recruitment Status : Terminated (failure rate 91.1%)
First Posted : July 5, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
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,

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniases Device: HECT-CL Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 4, 2017
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: HECT-CL
HECT-CL heat pack will be applied on CL lesions (50-52 degrees Celsius for 3 minutes on 7 consecutive days)
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.




Primary Outcome Measures :
  1. Effectiveness of the HECT-CL treatment as assessed by [ Time Frame: 180 days ]
    The proportion of patients with complete re-epithelisation at each follow up visit associated with the HECT-CL treatment

  2. Possible adverse effect of the HECT-CL treatment will studied by [ Time Frame: 180 days ]
    The proportion of patients experiencing adverse effects (AEs) and serious adverse effects (SAEs) (Safety)

  3. Ease of use of the HECT-CL treatment as assessed by [ Time Frame: 180 days ]
    the observation of, and feedback from health providers on the ease of (re-)use of the HECT-CL (feasibility).

  4. Acceptability of the HECT-CL treatment as assessed by [ Time Frame: 180 days ]
    proportion of patients completing the treatment schedule in time (feasibility)

  5. Inappropriateness of the HECT-CL treatment as assessed by [ Time Frame: 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 :
  1. The scars remaining after the HECT-CL treatment as assessed by [ Time Frame: 180 days ]
    the proportion of patients with remaining scars

  2. The duration of the healing process as assessed by [ Time Frame: 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).



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208543


Locations
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Pakistan
Mohtarma Shaheed Benazir Bhutto Hospital Quetta.
Quetta, Baluchistan, Pakistan, 00000
Sponsors and Collaborators
Medecins Sans Frontieres, Netherlands
Investigators
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Study Director: Koert Ritmeijer, PhD Medecins Sans Frontieres, Netherlands
Publications:
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Responsible Party: Medecins Sans Frontieres, Netherlands
ClinicalTrials.gov Identifier: NCT03208543    
Other Study ID Numbers: HECT-CLQTA
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medecins Sans Frontieres, Netherlands:
thermotherapy
Pakistan
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases