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Safety and efficacy of topical finasteride nanoemulgel 0.25% in the treatment of mild to moderate androgenetic alopecia on male and female pattern

Protocol summary

Study aim
Safety and efficacy of topical finasteride nanoemulgel 0.25% in the treatment of mild to moderate androgenetic alopecia on male and female pattern
Design
Single group, phase 2, before -after clinical study. sample size is 40. The study is not randomized.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 40 healthy volunteers will be selected and enrolled in the study after signing consent form. Volunteers are taught to use topical finasteride nanoemulgel 0.25% once in a day for 24 weeks. Before intervention, 2, 4 and 6 months after the start of treatment changing in hair lost will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or female aged 20-50 years, Hair Loss Status II, III, IV Based on Norwood Scale for men, Hair Loss Status I,II Based on Ludwick Scale for women, General health, Voluntary participation and signing written informed consent Exclusion criteria: Chronic active scalp disease other than hair loss, Using any prescribed drug or over-the-counter(OTC) for hair loss within the past 3 months, Women with abnormal hormonal tests, Women with Polycystic ovary(PCO), pregnancy or lactating women
Intervention groups
Treatment with topical finasteride nanoemulgel 0.25% in scalp area, once in a day for 24 weeks. This emulgel is prepared by high-speed homogenization method with nanoemulsion containing finasteride, which is prepared by materials such as lecithin, vitamin E, chloroform solvent, gelling, cholesterol, PEG 600 and distilled water.
Main outcome variables
Hair count changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190210042676N22
Registration date: 2022-05-13, 1401/02/23
Registration timing: prospective

Last update: 2022-05-13, 1401/02/23
Update count: 0
Registration date
2022-05-13, 1401/02/23
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of topical finasteride nanoemulgel 0.25% in the treatment of mild to moderate androgenetic alopecia on male and female pattern
Public title
Safety and efficacy of topical finasteride nanoemulgel 0.25% in the treatment of mild to moderate androgenetic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female aged 20-50 years Hair Loss Status II, III, IV Based on Norwood Scale for men Hair Loss Status I,II Based on Ludwick Scale for women General health Voluntary participation and signing written informed consent
Exclusion criteria:
Chronic active scalp disease other than hair loss Using any prescribed drug or over-the-counter(OTC) for hair loss within the past 3 months Women with abnormal hormonal tests Women with Polycystic ovary(PCO) pregnancy or lactating women
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Ethics committee in research of medical school-Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-09-15, 1400/06/24
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.664

Health conditions studied

1

Description of health condition studied
hair loss
ICD-10 code
L65.9
ICD-10 code description
Nonscarring hair loss, unspecified

Primary outcomes

1

Description
Hair count changes
Timepoint
Before intervention, 2, 4 and 6 months after the start of treatment
Method of measurement
Trichoscopy by Fotofinder

Secondary outcomes

1

Description
Changes in the ratio of anagen to telogen hair
Timepoint
Before intervention, 2, 4 and 6 months after the start of treatment
Method of measurement
Trichoscopy by Fotofinder

Intervention groups

1

Description
Intervention group: Treatment with topical finasteride nanoemulgel 0.25% in scalp area, once in a day for 24 weeks. This emulgel is prepared by high-speed homogenization method with nanoemulsion containing finasteride, which is prepared by materials such as lecithin, vitamin E, chloroform solvent, gelling, cholesterol, PEG 600 and distilled water.
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
Aniseh Samadi
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
dermalab@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbar Fotouhi
Street address
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical
City
Tehran
Province
Tehran
Postal code
141556446
Phone
+98 21 8899 2970
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
Manger of clinical study unit
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
aniseh_samadi@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
Proffesor of Dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 7921
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
Maryam Ahmadi
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
ahmadi.maryam648@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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