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Completed

NCT Number: NCT00257530

Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.

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Key information

Conditions

Cutaneous Leishmaniasis Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Cutaneous Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

5 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UPCH, Cusco, Peru

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males/Females between 5 and 65 yrs
  • CL diagnosis confirmed
  • >4 weeks time disease
  • no prior anti-leishmanial therapy for CL
  • negative pregnancy test
  • informed written consent or parent consent for <18yrs patients

Exclusion criteria

  • >25cm2 lesion(s)
  • >6 cutaneous lesions
  • mucosal lesion
  • previous exposure to Imiquimod or anti-leish treatment
  • participation in another protocol within 30 days prior study
  • other acute or chronic illness / medication that may interfere
  • significant psychiatric illness
  • anaphylaxis or severe allergic reaction to proposed drugs
  • patients unlikely to cooperate
  • concomitant infection
  • pregnancy or breast feeding

Treatment and study plan

Imiquimod

Drug

Primary outcomes

  1. Time to healing

  2. Reduction of scaring

Secondary outcomes

  1. Safety (measured by AE reporting) during treatment and follow up to 12 months

Sponsors and collaborators

Lead sponsor

Drugs for Neglected Diseases

Other

Registry information

Official study title

Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 23, 2005
Registry last updated
Jun 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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