deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT04515186

Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World

Efficacy and Safety of Thermotherapy in Combination With Miltefosine Compared Iltefosine Monotherapy for the Treatment of New World Cutaneous Leishmaniasis: A Phase III, Open Label, Multicenter Randomized Trial

Sponsor: Drugs for Neglected Diseases

Conditions Cutaneous Leishmaniases
Interventions Meglumine Antimoniate Miltefosine Thermotherapy machine
Updated 10 times since 2020 Last updated: May 5, 2025 Started: Jan 26, 2021 Primary completion: Nov 10, 2023 Completion: Feb 27, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Cutaneous Leishmaniases and is currently completed. Drugs for Neglected Diseases leads this study, which shows 10 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Nov 2021 · 7 months · monthly snapshotRecruiting~Nov 2021 – ~Oct 2023 · 23 months · monthly snapshotRecruiting~Oct 2023 – ~Mar 2024 · 5 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshotActive Not Recruiting~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

10 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Jun 2025 — Sep 2025 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Sep 2024 — Jun 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Mar 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

▶ Show 5 earlier versions

  1. Oct 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  2. Nov 2021 — Oct 2023 [monthly]

    Recruiting PHASE3

  3. Apr 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  4. Jan 2021 — Apr 2021 [monthly]

    Not Yet Recruiting PHASE3

  5. Sep 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Drugs for Neglected Diseases
Data source: Drugs for Neglected Diseases

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations