The effect of Biotin and Dexpanthenol on hair loss in patients with androgenic alopecia
Design
Clinical trials with control group, with parallel groups, not blind
Settings and conduct
Patients with types 1 to 4 of androgenetic hair loss referring to the dermatology department of Tabriz Sina Hospital were divided into 2 intervention and a control groups. The control group received Minoxidil 5% solution and Finasteride 1mg tablets. In the first intervention group, in addition to the above drugs, the injectable Biotin was used and in the second group, in addition to the base treatment, Biotin and Dexpanthenol Was prescribed. All three groups will be checked monthly in terms of reducing hair loss and increasing the number and thickness of hair within 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male; age 18-50; androgenetic alopecia type 1-4.
Non-inclusion criteria: Having varicocele; Willing to get pregnant.
Intervention groups
Patients with androgenic alopecia type 1 to 4 will be divided into a control group and two intervention groups.
Control group: Minoxidil 5% solution and Finasteride 1mg tablets were prescribed.
Intervention group 1: Minoxidil 5% solution and Finasteride 1mg tablets and Biotin ampoules were prescribed.
Intervention group 2: Minoxidil 5% solution and Finasteride 1mg tablets and Biotin and Dexpanthenol ampoules were prescribed.
Main outcome variables
Hair loss; the number and thickness of hair
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190430043438N1
Registration date:2019-06-17, 1398/03/27
Registration timing:retrospective
Last update:2019-06-17, 1398/03/27
Update count:0
Registration date
2019-06-17, 1398/03/27
Registrant information
Name
Sanaz Ghasempour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 4650
Email address
ghasempour_sanaz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-12-16, 1397/09/25
Actual recruitment end date
2019-03-16, 1397/12/25
Trial completion date
2019-05-18, 1398/02/28
Scientific title
The effect of Biotin and Dexpanthenol on hair loss in patients with androgenetic alopecia
Public title
The effect of Biotin and Dexpanthenol on androgenetic alopecia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men with androgenetic hair loss type 1 to 4
Exclusion criteria:
Having varicocele
Willing to get pregnant
Age
From 18 years old to 50 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
84
Randomization (investigator's opinion)
Not randomized
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
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-09-04, 1397/06/13
Ethics committee reference number
IR.TBZMED.REC.1397.466
Health conditions studied
1
Description of health condition studied
Androgenic alopecia
ICD-10 code
L64.8
ICD-10 code description
Other androgenic alopecia
Primary outcomes
1
Description
Score of hair loss
Timepoint
Measuring hair loss at the beginning of the study (before the intervention) and 30, 60 and 90 days after the start of the medication
Method of measurement
Monthly scoring for hair loss of 10 based on patient's claim
2
Description
The hair thickness
Timepoint
Measuring the thickness of the hair at the beginning of the study (before the intervention) and 30, 60 and 90 days after the start of the medication
Method of measurement
Trichoscope
3
Description
The number of hair in a circle 2.54 cm in diameter
Timepoint
Counting the number of hair at the beginning of the study (before the intervention) and 30, 60 and 90 days after starting the medication
Method of measurement
Macrophotography technique
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Minoxidil solution 5%, produced by Pak darou inc, 20 drops, twice a day, for 3 months and finasteride 1 mg tablet, produced by Shafa inc, 1 tablet daily for 3 months
Category
Treatment - Drugs
2
Description
Intervention group 1: Minoxidil solution 5%, produced by Pak darou inc, 20 drops twice a day for 3 months and Finasteride tablet 1 mg, produced by Shafa inc, 1 tablet daily for 3 months and Biotin IM injections 5 mg / ml, produced by Oxin darou vesht, every 5 days for 3 months.
Category
Treatment - Drugs
3
Description
Intervention group 2: Minoxidil solution 5% of the Pak darou inc, twice daily 20 drops for 3 months and Finasteride tablet 1 mg of Shafa inc, 1tablet daily for 3 months and biotin ampoule 5 mg / ml Oxin darou vesht every 5 days for 3 months (IM) And dexpantol ampoule 500 mg / 2 ml each. Oxin darou vesht every 5 days for 3 month (IM)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital affiliated to Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Ghasempour
Street address
Sina hospital, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Email
research-vice@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Tabriz University of Medical Sciences, Daneshgah street, Tabriz