NCT02927496: LeDoxy-Mali

A 24 Month Study, to Compare the Efficacy of Doxycycline vs. Placebo for Improving Filarial Lymphedema in Mali

Completed Phase 3 Last updated 24 June 2021

What this trial tests

Phase 3 trial testing Doxycycline in Lymphedema in 220 participants. Completed in 19 December 2020.

Timeline

19 June 2018

Primary endpoint
19 December 2020

19 December 2020

Quick facts

Lead sponsor	The Task Force for Global Health
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	220
Start date	19 June 2018
Primary completion	19 December 2020
Estimated completion	19 December 2020
Sites	1 location across Mali

Drugs / interventions tested

• Doxycycline (doxycycline) — full drug profile →
• Placebo

Conditions studied

• Lymphedema — all drugs for Lymphedema →
• Lymphatic Filariasis — all drugs for Lymphatic Filariasis →
• Filariasis — all drugs for Filariasis →

Sponsor

The Task Force for Global Health

Who can join

Adults 14 to 65, any sex, with Lymphedema or Lymphatic Filariasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Current lymphedema management protocols are based on the use of simple measures of hygiene (regular washing with soap and water, skin and nail care), use of topical antibiotics or antifungal agents, exercise and footwear. This is considered the "standard of care" in most endemic countries in the absence of any structured treatment programs. Previous controlled clinical trials and extensive field experience have shown the benefit of these measures in reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the progression of lymphedema.

In the present study, the progression of lymphedema in a group of patients who receive a six-week course of doxycycline will be compared with that of a group who receives doxycycline "look-alike" placebo tablets. However, both groups will be enrolled into a standardized "regimen of hygiene" described above. Thus, patients enrolled in the "placebo" group also will receive the current standard of care, and the placebo used in the study will help to identify the benefits of doxycycline on a background of simple hygiene measures. The regimens will be explained to all participants who will be trained to use established standardized methods of hygiene and be effectively applying it prior to the initiation of the drug treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common, generic SOP with handouts that describes methods and the training schedule will be used so that similar methods are employed across all sites.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Use of a Novel Portable Three-Dimensional Imaging System to Measure Limb Volume and Circumference in Patients with Filarial Lymphedema.
   Yahathugoda C, Weiler MJ, Rao R, De Silva L, et al · · 2017 · cited 32× · PMID 29141750 · DOI 10.4269/ajtmh.17-0504
2. The design and development of a multicentric protocol to investigate the impact of adjunctive doxycycline on the management of peripheral lymphoedema caused by lymphatic filariasis and podoconiosis.
   Horton J, Klarmann-Schulz U, Stephens M, Budge PJ, et al · · 2020 · cited 21× · PMID 32228663 · DOI 10.1186/s13071-020-04024-2
3. Portable infrared imaging for longitudinal limb volume monitoring in patients with lymphatic filariasis.
   Zhou C, Yahathugoda C, De Silva L, Rathnapala U, et al · · 2019 · cited 8× · PMID 31584959 · DOI 10.1371/journal.pntd.0007762
4. Effect of Adding a Six-Week Course of Doxycycline to Intensive Hygiene-Based Care for Improving Lymphedema in a Rural Setting of Mali: A Double-Blind, Randomized Controlled 24-Month Trial.
   Coulibaly YI, Diabate AF, Sangare M, Thera SO, et al · · 2024 · cited 6× · PMID 39013374 · DOI 10.4269/ajtmh.23-0908
5. Filariasis research - from basic research to drug development and novel diagnostics, over a decade of research at the Institute for Medical Microbiology, Immunology and Parasitology, Bonn, Germany.
   Karunakaran I, Ritter M, Pfarr K, Klarmann-Schulz U, et al · · 2023 · cited 5× · PMID 38655130 · DOI 10.3389/fitd.2023.1126173
6. Lymphedema in three previously Wuchereria bancrofti-endemic health districts in Mali after cessation of mass drug administration.
   Dolo H, Coulibaly YI, Konipo FN, Coulibaly SY, et al · · 2020 · cited 4× · PMID 31941448 · DOI 10.1186/s12879-020-4777-6
7. Implementation of basic package of care improved socio-economic conditions of lymphedema patients in rural Mali after two years follow-up.
   Dolo H, Tanapo D, Thera SO, Sangaré M, et al · · 2025 · PMID 41218023 · DOI 10.1371/journal.pgph.0005454