Protocol summary

Study aim
Comparison of the Effect of Minoxidil Nanosulfanation with 2% Minoxidil Solution on the Market for the Treatment of Androgenetic Olopecia
Design
Clinical practice, community-based and pragmatic control group, with parallel, blind, randomized groups
Settings and conduct
This test is done at the Haj Dai Clinic of Kermanshah. At the time of 0, 2, 4, and 6 months, the hair density, hair stroke diameter and overall satisfaction of the patient and blind researcher are measured from the overall growth of the hair.
Participants/Inclusion and exclusion criteria
140 patients with androgenetic alopecia at the age of 18 to 55 years are enrolled in the study. People taking medications such as systemic corticosteroids, anti-androgens, or pregnant and lactating patients are excluded.
Intervention groups
Patients are divided into two groups equally and randomly divided into a group of minoxidil nanoparticles and the other 2% of the 2% solution of minoxidil is available on the market. The two groups receive 2 times daily for 6 months each day from the solution given to them. Is used
Main outcome variables
Hair stalk diameter, hair density, hair growth, headache, erythema, scaling, itching, folliculitis, hirsutism, Hypo-hyperpigmentation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180120038450N1
Registration date: 2018-07-10, 1397/04/19
Registration timing: registered_while_recruiting

Last update: 2018-07-10, 1397/04/19
Update count: 0
Registration date
2018-07-10, 1397/04/19
Registrant information
Name
Shahla Mirzaeei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3824 0526
Email address
shahlamirzaeei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-13, 1397/03/23
Expected recruitment end date
2019-06-13, 1398/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A camparative study effectiveness topical minoxidil nanosuspention and minoxidil 2% solution in the treatment of alopecia androgenetic
Public title
A camparative study effectiveness topical minoxidil nanosuspention and minoxidil %2 solution in the treatment of alopecia androgenetic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Signature of written consent for participation in the study 2-Age between 18-55 years 3-The presence of alopecia androgenetic in male or female 4-There is no other disorder that causes hair loss such as telogeny, echolinate or scarring hair (like lichen planus) Class 1-4 in the Fitzpatrick Classification for Skin Type and Grade 3-6 Hair Loss for Men in the Norwood Hamilton Classification and Grade 2-3 Hair Loss for Women in the Ludwing Classification, Non-Use of Finasteride, Anti-Androgenetics, Local Estrogen , Progesterone, tamoxifen, anabolic steroids, potent potent medications for hyperkeratosis, oral glucocorticoid, lithium, phenothiazines within 3 months before the start of the study
Exclusion criteria:
1-Pregnancy 2-lactation 3-Using of anabolic steroids in the last 6month 4-Using of topical minoxidil in the last 6month 5-Using of antiandrogenetic drugs in the last 6 month 6-Using of the drugs who make hyper keratosis as like as systemic corticosteroids in the last 6 month 7-Dont be principled to curative protocol 8-Hair transplantation 9-Collagen vascular disease or HIV 10-Endocrinopathy like PCO, Hypotyroid
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
140 patients are randomly divided into two groups of 70 people
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, the prescribing physician, the data collector, the prospector who is developing, the one who evaluates the outcomes, and who analyzes the data, are unaware of the type of drug.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Central Office of Kermanshah University of Medical Sciences-Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714858743
Approval date
2018-06-13, 1397/03/23
Ethics committee reference number
IR.KUMS.REC.1397.138

Health conditions studied

1

Description of health condition studied
alopecia areata
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hair density
Timepoint
0,2,4,6 months
Method of measurement
Phototyrographic method

2

Description
Diagonal hair shaft
Timepoint
0,2,4,6
Method of measurement
Phototyrographic method

3

Description
Patient satisfaction
Timepoint
2,4,6 months
Method of measurement
questionnaire

Secondary outcomes

1

Description
Headache
Timepoint
2,4,6 months
Method of measurement
Ask the patient

2

Description
Erythema - redness-itching
Timepoint
0,2,4,6 month
Method of measurement
Ask the patient

3

Description
Hypopigmentation, hyperpigmentation
Timepoint
0,2,4,6 month
Method of measurement
Evaluate by observation and Ask the patient

Intervention groups

1

Description
Intervention group: Topical minoxidil nanosuspention
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
کلینیک ویژه پوست حاج دایی
Full name of responsible person
شهلا میرزایی
Street address
pharmacy school, Parastar Bolvar, Daneshga Ave, shirodi bolvar, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6480
Email
shahlamirzaeei@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
شهلا میرزایی
Street address
Kermanshah University of medical sciences, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6480
Email
shahlamirzaeei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Shahla Mirzaeei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
کرمانشاه - بلوار شهید بهشتی - ساختمان مرکزی دانشگاه علوم پزشکی کرمانشاه
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6480
Email
shahlamirzaeei@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shahla Mirzaeei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
14, 11 Abkaei,Bargh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3824 0526
Fax
Email
shahlamirzaeei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shahla Mirzaeei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
14, 11 Abkaei,Bargh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3824 0526
Fax
Email
shahlamirzaeei@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
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
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