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Cutaneous LeishmaniasesPhase 3HECT-CLNCT03208543

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

A Phase 3 study testing HECT-CL in people with Cutaneous Leishmaniases, run by Medecins Sans Frontieres, Netherlands at 1 site in Pakistan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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, Read more about this study

Who is it for?
Ages 10 years and olderHealthy volunteers can take part
Conditions the study is for
Cutaneous Leishmaniases
What is being tested?
HECT-CL
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 sitePakistan
Study dates
4 Oct 2017to 20 Dec 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Mohtarma Shaheed Benazir Bhutto Hospital Quetta.

    Quetta, Balochistan, 00000

Other trials in Pakistan

About this study

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

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,

Read the 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.

Being tested
HECT-CL
Keywords
thermotherapy, Pakistan
Medical subject headings
Leishmaniasis, Cutaneous, Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HECT-CLDevice

    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.

Study groups in NCT03208543
Study groupRoleWhat they receive
HECT-CLExperimentalHECT-CL heat pack will be applied on CL lesions (50-52 degrees Celsius for 3 minutes on 7 consecutive days)
Receives: Device: HECT-CL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 180 days

  2. 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)

    Measured: 180 days

  3. 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).

    Measured: 180 days

  4. Acceptability of the HECT-CL treatment as assessed by

    proportion of patients completing the treatment schedule in time (feasibility)

    Measured: 180 days

  5. 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)

    Measured: 180 days

Secondary outcomes (2)

  1. The scars remaining after the HECT-CL treatment as assessed by

    the proportion of patients with remaining scars

    Measured: 180 days

  2. 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).

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2017
  2. Study start4 Oct 2017
  3. Primary completion20 Dec 2017
  4. Study completion20 Dec 2017

Why it stopped: failure rate 91.1%

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03208543
Sponsor's protocol ID
HECT-CLQTA
Acronym
HECT-CL
Status last verified
Jan 2019
First submitted
26 May 2017
Last updated
16 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25842586

  • 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.

    PubMed 23556016

  • 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.

    PubMed 15791515

  • 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.

    PubMed 23658851

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HECT-CL in people with Cutaneous Leishmaniases, run by Medecins Sans Frontieres, Netherlands at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: failure rate 91.1%). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of the HECT-CL treatment as assessed by (time frame: 180 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03208543, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.

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