Safety Evaluation of Topical Application of Nano-Liposomal Form of Amphotericin B (Sinaampholeish) in comparison with placebo on Healthy Volunteers; Phase I Clinical Trial.
To evaluate the safety of SinaAmpholeish in a double-blind, randomized, phase 1 clinical trial in healthy human volunteers.
Design
A randomized controlled trial, parallel, double-blind with the sample size of 27 volunteers (left and right volar side of their forearm).
Settings and conduct
54 forearms of 27 healthy volunteers who are blinded to intervention groups are randomly assigned to the active group and receive topical Nano-liposomal amphotericin-B 0.4% on one side and receive placebo on the other side of their forearms.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy volunteer aged between 18-65 who are willing to participate in the study and signing the informed consent.
Exclusion Criteria: The history of any diseases or illness, mental illness, participating in another trial concurrently
Intervention groups
Intervention group includes left or right sides of the volar side of forearms which topical Nano-liposomal amphotericin-B 0.4% (15-g tubes), Razak Laboratories Company was applied. Control group include the opposite side of participants forearm which only receive the placebo ( vehicle of active drug).
Main outcome variables
Erythema, Pruritus, and other possible adverse reaction (by clinical exam or participants history)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081130001475N12
Registration date:2019-02-21, 1397/12/02
Registration timing:retrospective
Last update:2019-02-21, 1397/12/02
Update count:0
Registration date
2019-02-21, 1397/12/02
Registrant information
Name
Ali Khamesipour
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 0657
Email address
khamesipour@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2012-06-13, 1391/03/24
Expected recruitment end date
2012-07-13, 1391/04/23
Actual recruitment start date
2012-07-13, 1391/04/23
Actual recruitment end date
2012-07-13, 1391/04/23
Trial completion date
2012-07-13, 1391/04/23
Scientific title
Safety Evaluation of Topical Application of Nano-Liposomal Form of Amphotericin B (Sinaampholeish) in comparison with placebo on Healthy Volunteers; Phase I Clinical Trial.
Public title
"Safety Evaluation of Topical Application of Nano-Liposomal Amphotericin B (Sinaampholeish)"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy volunteer
aged between 18-65
willingness to participate in the study and signing the informed consent form
Exclusion criteria:
Any disease or illness according to subject history
Mentally ill based on physician diagnosis
participating in other concurrent trial
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
27
More than 1 sample in each individual
Number of samples in each individual:
2
The volar side of left or right forearm in each participant
Actual sample size reached:
27
More than 1 sample in each individual
Actual sample size in each individual:
2
The volar side of left or right forearm in each participant
Randomization (investigator's opinion)
Randomized
Randomization description
The master sheet of randomization was generated using online software before study conduct (Simple randomization method). Trial labels were put on the drugs. The Nano-liposomal formulation of amphotericin-B and its vehicle (as placebo) were prepared in identical tubes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Regarding the similar appearance of active drug and placebo, neither the volunteers nor the investigators were aware of the type of medication applied on each side.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Center for Research & Training in Skin Diseases & Leprosy, Tehran University of
Street address
No. 415, Taleghani St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14166-13675
Approval date
2012-06-13, 1391/03/24
Ethics committee reference number
92-3450
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
Erythema
Timepoint
Daily evaluation after the 1st day of intervention to 7th day.
Method of measurement
clinical exam
2
Description
Pruritus
Timepoint
Daily evaluation after the 1st day of intervention to 7th day.
Method of measurement
clinical Exam
Secondary outcomes
1
Description
Any reported adverse events
Timepoint
Daily evaluation after the 1st day of intervention to 7th day.
Method of measurement
Participants history
Intervention groups
1
Description
Intervention group: Topical Nano-liposomal formulation of 0.4% Amphotericin B was applied on the left or right volar side of forearm twice a day for one week
Category
Treatment - Drugs
2
Description
Control group: ،Topical placebo ( vehicle of active drug) was applied on the left or right volar side of forearm twice a day for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Research and Training in Skin Diseases and Leprosy
Full name of responsible person
Alireza Firooz
Street address
No. 415, Taleghani St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0657
Email
firozali@sina.tums.ac.ir
Web page address
http://crtsdl.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neglected Diseases Initiative
Full name of responsible person
Neglected Diseases Initiative (DNDi)
Street address
15 Chemin Louis-Dunant 1202 Geneva Switzerland
City
geneva
Postal code
21936-00505
Phone
+41 22 906 92 30
Fax
+41 22 906 92 31
Email
dndi@dndi.org
Web page address
https://www.dndi.org/
Grant name
Safety Evaluation of Topical Application of Nano-Liposomal Form of Amphotericin B (Sinaampholeish) on Healthy Volunteers; Phase I Clinical Trial
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neglected Diseases Initiative
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
UN agencies and international organizations
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooze
Position
Profosser
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 21,22th alley,sanaeie st,karimkhan st
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0657
Fax
+98 21 8888 1719
Email
firozali@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Ali Khamesipour
Position
Prof./PhD
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
No.415 Taleghani St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Fax
Email
ali.khamesipour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Khamesipour
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
No 79, Taleghani Avenue.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0657
Fax
+98 21 8897 0658
Email
khamesipour@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available