Evaluation of safety and the effectiveness of Caffeine Plus Siseh anti-hair loss line (tonic and shampoo) produced by Sina Trading Company In the prevention and treatment of androgenic hair loss
Evaluation of safety and the effectiveness of Caffeine Plus Siseh anti-hair loss line (tonic and shampoo) produced by Sina Trading Company in the prevention and treatment of androgenic hair loss
Design
Single group, phase 2, before -after clinical study. sample size is 20. 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, 20 healthy volunteers will be selected and enrolled in the study after signing consent form. Volunteers are taught to use Caffeine liquid Plus Siseh anti-hair loss tonic once a day for 12 weeks and Caffeine Plus Siseh anti-hair loss shampoo for hair washing. Before intervention and at the end of 6 and 12 weeks later changing in hair lost will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male aged 18-50 years, General health, Voluntary participation and signing written informed consent, Hair Loss Status II, III, IV Based on Norwood Scale
Exclusion criteria: Chronic active scalp disease other than hair loss, Using any prescribed drug or OTC for hair loss within the past 3 months, People with allergies to tonic and shampoo ingredients, Any severe weight loss or strict diet therapy during the study
Intervention groups
A-Intervention group: Topical use of Caffeine Plus Siseh anti-hair loss serum produced by Sina Trading Company once a day, for 12 weeks.
B-Intervention group: Topical use of Caffeine Plus Siseh anti-hair loss shampoo produced by Sina trading company at least three times in a week, for 12 weeks.
Main outcome variables
Hair lost Changes, based on Global photographic review
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161207031288N8
Registration date:2021-05-04, 1400/02/14
Registration timing:prospective
Last update:2021-05-04, 1400/02/14
Update count:0
Registration date
2021-05-04, 1400/02/14
Registrant information
Name
Saman Ahmad Nasrollahi
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 8190
Email address
snasrollahi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-15, 1400/02/25
Expected recruitment end date
2021-11-16, 1400/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and the effectiveness of Caffeine Plus Siseh anti-hair loss line (tonic and shampoo) produced by Sina Trading Company In the prevention and treatment of androgenic hair loss
Public title
Evaluation of safety and the effectiveness of Caffeine Plus Siseh anti-hair loss tonic and shampoo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male aged 18-50 years
General health
Voluntary participation and signing written informed consent
Hair Loss Status II, III, IV Based on Norwood Scale
Exclusion criteria:
Chronic active scalp disease other than hair loss
Using any prescribed drug or OTC for hair loss within the past 3 months
People with allergies to tonic and shampoo ingredients
Any severe weight loss or strict diet therapy during the study
Age
From 18 years old to 50 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
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 of 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
2021-03-13, 1399/12/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1256
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 lost Changes, based on Global photographic review
Timepoint
Before intervention, 6 and 12 weeks after the start of use
Method of measurement
One independent dermatologist will perform clinical assessments in a blinded fashion by scoring every photograph according to the Global photographic review scale .
Secondary outcomes
1
Description
Hair count changes
Timepoint
Before intervention, 6 and 12 weeks after the start of use
Method of measurement
Trichoscopy By Fotofinder
2
Description
Changes in percentage of anagen to telogen
Timepoint
Before intervention, 6 and 12 weeks the start of use
Method of measurement
Trichoscopy by Fotofinder
Intervention groups
1
Description
Intervention group: Topical use of Caffeine Plus Siseh anti-hair loss serum (Contains 3% prokapil, Ulnalic acid, Biotinyl tripeptide, Caffeine, etc..) produced by Sina Trading Company once a day, for 12 weeks and Topical use of Caffeine liquid Plus Siseh anti-hair loss shampoo (Contains 3% prokapil, Caffeine complex contains vitamin B5 and Zinc PCA) produced by Sina trading company at least three times in a week, for 12 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy