This study is designed to compare the therapeutic effects of a formulation of topical liposomal Amphotricin B with intralesional Meglumine Antimoniate (Gllucantime) in the treatment of cutaneous Leishmaniasis due to Leishmania Tropica. 110 patients (55 patients in each group) with cutaneous leishmaniasis approved by either a direct smear stained with Giemsa or a positive skin biopsy of lesions with less than 6 months duration were enrolled in a randomized, single-blind controlled trial done during a 24-month period in Mashhad. The first group received liposomal Amphotericin B, 3-7 drops twice daily, according to the size of lesion, for 8 weeks. The second group received intralesional glucantime once a week, to the point when the surface of lesion became fully infiltrated (up to a maximum dose of 2 ml for 8 weeks). The treatment period was 8 weeks for each group and the patients are followed up every two weeks during the treatment course and the changes in the size of lesion and induration were recorded in every session. The primary outcome measure was complete healing of cutaneous leismaniasis lesion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802131871N1
Registration date:2009-09-26, 1388/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-09-26, 1388/07/04
Registrant information
Name
Pouran Layegh
Name of organization / entity
Department of Dermatology, Qaem Hospital, Mashad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1881 4988
Email address
layeghpo@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2004-09-10, 1383/06/20
Expected recruitment end date
2006-09-10, 1385/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Topical Liposomal Amphotericin B versus Intralesional Meglumine Antimoniate (Glucantime) in the Treatment of Cutaneous Leishmaniasis
Public title
Comparing efficacy of two treatment methods including topical liposomal Amphotericin B versus intralesional Meglumine Antimoniate (Glucantime) in the Treatment of Cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of cutaneous leishmaniasis approved by either a direct smear stained with Giemsa or a positive skin biopsy of lesions with less than 6 months duration, in cases of previous history of anti-leishmania therapy, a 3 month treatment free interval from the last treatment course
Exclusion criteria: Pregnancy, breast feeding, taking any other specific treatment while participating in the study, past medical history of any local or systemic disease during the last 2 months, presence of significant underlying disease such as cardiac, renal or liver dysfunction
Age
From 2 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences, Mashad, Iran
City
Mashad
Postal code
Approval date
2004-08-10, 1383/05/20
Ethics committee reference number
1803-ت
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous Leishmaniasis
Primary outcomes
1
Description
Complete healing
Timepoint
First time within 8 weeks after beginning of treatment and second one after 6 months after initiation of the intervention(s)
Method of measurement
Measuring the size of induration and ulcer
Secondary outcomes
1
Description
Adverse Effects
Timepoint
Recorded at each follow-up visit
Method of measurement
Taking medical history and performing physical examination
Intervention groups
1
Description
Multilamellar Large Vesicle (MLV) liposomes containing Amphotricin B, prepared by freeze drying method, 3-7 drops twice-daily, according to the lesion's size for 8 weeks or complete healing of the lesion.
Category
Treatment - Drugs
2
Description
Intralesional glucantime (Specia®, France) once a week, to the point when the lesion’s surface became fully infiltrated, up to a maximum dose of 2 ml for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Cutaneous Leishmaniasis, Research Center of Skin Disease and Cutaneous leishmaniasis, Qaem
Full name of responsible person
Dr Poura Layegh, Dr Parisa Emamgholi -Tabar Malekshah
Street address
Qaem Hospital, Ahmad Abad Avenu
City
Mashad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Research Council of Mashhad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences, Mashad, Iran
City
Mashad
Grant name
Grant code / Reference number
1803-ت
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Dermatology, Qaem Hospital, Mashad University of Medical Sciences
Full name of responsible person
Dr Pouran Layegh
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology,Qaem Hospital, Mashad University of Medical Sciences
City
Mashad
Postal code
00989177965583
Phone
+98 51 1881 4988
Fax
+98 51 1841 2081
Email
layeghpo@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Dermatology, Qaem Hospital, Mashad University of Medical Sciences
Full name of responsible person
Dr Pouran Layegh
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Qaem Hospital, Mashad University of Medical Sciences
City
Mashad
Postal code
Phone
+98 51 1881 4988
Fax
Email
layeghpo@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qaem Hospital, Mashad University of Medical Sciences
Full name of responsible person
Dr Pouran Layegh
Position
Associate professor of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Qaem Hospital, Mashad University of Medical Sciences
City
Mashad
Postal code
Phone
+98 51 1881 4988
Fax
+98 51 1840 9612
Email
layeghpo@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)