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

NCT03208543 | Terminated Phase 3

• 1 other identifier: HECT-CLQTA
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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,

Conditions

Cutaneous Leishmaniases

Keywords

thermotherapy; Pakistan

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Acceptability of the HECT-CL treatment as assessed by

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

  180 days

• 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 Outcomes (2)

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

  180 days

• The duration of the healing process as assessed by

  180 days

Study Arms (1)

HECT-CL

EXPERIMENTAL

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

Device: HECT-CL

Interventions

HECT-CL DEVICE

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.

HECT-CL

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medecins Sans Frontieres, Netherlands: lead

Study Sites (1)

Mohtarma Shaheed Benazir Bhutto Hospital Quetta.

Quetta, Balochistan, 00000, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 25842586 BACKGROUND

• 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.

  PMID: 23556016 BACKGROUND

• 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.

  PMID: 15791515 BACKGROUND

• 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.

  PMID: 23658851 BACKGROUND

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Hyperthermia

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Koert Ritmeijer, PhD

  Medecins Sans Frontieres, Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: July 5, 2017
• Study Start: October 4, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

PA (1)