Protocol summary

Study aim
Evaluation of efficacy and safety of topical nano-liposomal amphotericin B 0.4% to treatment of onychomycosis
Design
Interventional Clinical Pilot Study , Single group , Sample size of 15 persons
Settings and conduct
Patients should use topical 0.4% nanoliposomal amphotericin B twice a day on the whole surface of affected nails and 5mm of the contiguous skin. the treatment duration is 12 weeks for fingernails and 24 weeks for toenails. after the first visit, 3 follow-up visits at week 12, 24 and 36 will take place. the endpoint of the study will be at week 24 or 36.
Participants/Inclusion and exclusion criteria
Inclusion: 18 to 60 y/o, good general health, effective nail growth, compliance, confirmed diagnosis of onychomycosis Exclusion: Oral/ IV antifungal therapy in the past 12w, or topical in the past 4w, immunosuppression, Uncontrolled DM, nail surgery, concomitant nail disease, pregnancy
Intervention groups
Intervention: topical nano-liposomal amphotericin B 0.4% twice daily for 12 and 36 weeks on target finger and toe nails respectively.
Main outcome variables
states of partial clinical response (PCR), effective clinical response (ECR), complete cure (CC), mycological cure (MC)

General information

Reason for update
Acronym
amb
IRCT registration information
IRCT registration number: IRCT20150101020514N18
Registration date: 2023-01-05, 1401/10/15
Registration timing: retrospective

Last update: 2023-01-05, 1401/10/15
Update count: 0
Registration date
2023-01-05, 1401/10/15
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-26, 1400/04/05
Expected recruitment end date
2021-08-31, 1400/06/09
Actual recruitment start date
2021-06-26, 1400/04/05
Actual recruitment end date
2021-07-27, 1400/05/05
Trial completion date
2022-12-19, 1401/09/28
Scientific title
Evaluation of Efficacy and Safety of Topical Nano-liposomal Amphotericin B 0.4% for Treatment of Onychomycosis: An Interventional Clinical Pilot Study
Public title
Efficacy of topical Nano-liposomal Amphotericin B 0.4% for Treatment of Onychomycosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female subjects of any race, 18 to 60 years of age (inclusive). Verbal and written informed consent/assent obtained from the subject. Good general health, as assessed by the investigator, based on the subject's medical history, physical examination, and safety laboratory tests. Target nails for all subjects, must have had evidence of nail growth, per subject's report that monthly clipping is needed. Subjects are willing to comply with study instructions and return to the vising clinic for all required appointments each 12 weeks for at least 3 visits. confirmed diagnosis of onychomycosis via KOH direct smear and positive culture
Exclusion criteria:
Male or female who have received oral/ IV antifungal therapy within the past 12 weeks prior to screening. the male or female individual were used topical antifungal during the previous 4 weeks before screening Patients who had a history of immunosuppression /or clinical evidence indicating possible immunosuppression. Uncontrolled diabetics. Patients that have performed a surgical intervention for nail dystrophy in the past. Any illness or condition that could have caused nail anomalies or adversely affected the assessment. Or, presence of any nail infection other than onychomycosis or in addition to onychomycosis. Patients who had received immunosuppressive therapy in the past 3 months prior to screening visit or who had the need for it. Females who are pregnant, nursing a child, or planning a pregnancy during the study duration.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 15
Actual sample size reached: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Research Ethics Committee of Tehran University
Street address
Tehran university of medical science
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.TUMS.VCR.REC.1398.304

Health conditions studied

1

Description of health condition studied
Fungal nail Infection
ICD-10 code
L62.8
ICD-10 code description
Nail disorders in other diseases classified elsewhere

Primary outcomes

1

Description
state of clinical response, including: 1-partial clinical improvement which means decrease in the nail surface involvement to 10 -50% nail bed surface , or complete cure which means decrease in the nail surface involvement to <10% nail bed surface.
Timepoint
Base ( first visit) / week 12/ week 24 / week 36
Method of measurement
Physical examination, direct examination and culture for fungal elements

2

Description
Mycological cure
Timepoint
Base ( first visit) / week 12/ week 24 / week 36
Method of measurement
Physical examination, direct examination and culture for fungal elements

Secondary outcomes

empty

Intervention groups

1

Description
0.4% nano-liposomal amphotericin B gel is prescribed for the patients after they are educated on how to properly use the medication. Patients are asked to apply the gel topically twice daily on the entire surface of the affected nails and on a 6mm margin around the cuticle. The treatment must be done minimum 12 weeks for patient with finger nail onychomycosis and 24 weeks for those with toe nail onychomycosis.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for Research and Training in Skin Disease and Leprosy
Full name of responsible person
Dr. Mahsa Fattahi
Street address
Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Fax
+98 21 8896 3804
Email
dr.mahsafattahi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Center For Research and Training in Skin Disease and Leprosy
Full name of responsible person
Dr. Alireza Firooz
Street address
Taleghani ave
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Fax
+98 21 8896 3804
Email
alifiruz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center For Research and Training in Skin Disease and Leprosy
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Alireza Firooz
Position
Directory of recerach center for skin disese and leprosy
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Taleghani ave
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Fax
+98 21 8896 3804
Email
alifiruz@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Center for research and training in skin disease and leprosy
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Taleghani ave
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
firozali@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mahsa Fattahi
Position
Assistant proffessor of medical mycology
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
Taleghani ave
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dr.mahsafattahi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only in published article
When the data will become available and for how long
After publication of article
To whom data/document is available
Clinicians, pharmacologist, medical mycologist
Under which criteria data/document could be used
-----
From where data/document is obtainable
Center for Research and Training in Skin Disease and Leprosy
What processes are involved for a request to access data/document
After publication of article
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