The effect of latanoprost-containing lipid nanocarriers on androgenic alopecia
Design
Clinical trial with control group, not blinded, with parallel groups, non-randomized, phase 3, and 16 patients
Settings and conduct
In order to evaluate the effectiveness of lipid nanoparticles containing latanoprost in compare with it's solution, a study will be performed on 16 male volunteers aged 25-50 years with manifestations of androgenic hair loss. All volunteers will take both formulations of the drug at home once every 3 days. And their photography will be done and compared in a beauty clinic under the supervision of a dermatologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male, age between 23 to 50 years, with androgenic alopecia
Exclusion criteria: History of skin cancer, manifestations of skin disease in the desired area, history of hair transplantation
Intervention groups
Evaluation of the effect of lipid nanocarriers containing latanoprost in volunteers with androgenic alopecia on the right side of the head and a solution containing latanoprost on the left side of the head
Main outcome variables
Hair loss; Number and thickness of hair strands
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211209053339N1
Registration date:2022-01-15, 1400/10/25
Registration timing:prospective
Last update:2022-01-15, 1400/10/25
Update count:0
Registration date
2022-01-15, 1400/10/25
Registrant information
Name
Shadi Mahramfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3478 5226
Email address
shadi1995mahramfar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-30, 1400/11/10
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of nanostructured lipid carriers containing latanoprost to control androgenic alopecia
Public title
The effect of nanostructures of Latanoprost on male pattern hair loss
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male gender
Age between 23 to 50 years
manifestations of androgenic hair loss
Exclusion criteria:
History of skin cancer
History of physical therapy on the scalp during the last 6 months
Manifestations of skin disease in the desired area
History of hair transplantation
Age
From 23 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
16
More than 1 sample in each individual
Number of samples in each individual:
2
One sample contains latanoprost solution and the other sample contains latanoprost nanoparticles.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 Tabriz University of Medical Sciences
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Approval date
2021-04-26, 1400/02/06
Ethics committee reference number
IR.TBZMED.REC.1400.082
Health conditions studied
1
Description of health condition studied
Androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Hair diameter
Timepoint
Before starting treatment and also at weeks 4, 8, 12, 16, 20 and 24
Method of measurement
Trichoscope
2
Description
Hair color
Timepoint
Before starting treatment and also at weeks 4, 8, 12, 16, 20 and 24
Method of measurement
Trichoscope
3
Description
hair density
Timepoint
Before starting treatment and also at weeks 4, 8, 12, 16, 20 and 24
Method of measurement
Trichoscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Evaluation of the effect of lipid nanostructures containing latanoprost in the form of lotion on androgenic hair loss in male volunteers who will take the drug every 3 days for 6 months in amount of 0.25 cc with a 0.2% concentration on the right side of their head.
Category
Treatment - Drugs
2
Description
Evaluation of the effect of latanoprost solution on androgenic hair loss in comparison with its nanolipid form in male volunteers who take the drug every 3 days for six months in amount of 0.25 cc with a concentration of 0.02% on the left side of the head.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hamed Hamishehkar
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 5389
Email
Hamishehkar.hamed@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hamed Hamishehkar
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 5389
Email
Hamishehkar.hamed@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shadi Mahramfar
Position
pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 5389
Email
Shadi1995mahramfar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hamed Hamishehkar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 5389
Email
Hamishehkar.hamed@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shadi Mahramfar
Position
pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Medical Education Research and Development Complex (formerly Pashmineh), Pharmaceutical Nanotechnology Research Center., Opposite to Shahid Madani Hospital.,University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 5389
Email
Hamishehkar.hamed@gmail.com
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
Yes - There is 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
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document