Clinical investigation of the safety and effectiveness of Excilia Hair strengthening and ani hair loss Lotion in improving male pattern androgenic hair loss
Clinical investigation of the safety and effectiveness of Excilia Hair strengthening and ani hair loss Lotion in improving male pattern androgenic hair loss
Design
Single group, phase 2, before -after clinical study. sample size is 25. 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, 25 healthy volunteers will be selected and enrolled in the study after signing consent form. Volunteers are taught to use Topically use of Excilia Hair strengthening and anti-hair loss lotion for 24 weeks. Before intervention, 8,16,24 and 32 weeks after the start of use changing in hair lost will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Male aged 18-55 years
General health
Hair Loss Status II, III, IV Based on Norwood Scale
Voluntary participation and signing written informed consent
Exclusion criteria:
Chronic active scalp disease other than hair loss
Using any prescribed drug or OTC for hair loss within the past 3 months
Documented sensitivity to formulation components
Any severe weight loss or strict diet therapy during the study
Oral or topical treatment of minoxidil within 6 months before entering the study.
Intervention groups
Topically use of Excilia Hair strengthening and anti-hair loss lotion; Includes: Minoxidil oxathiazolidine carboxylate 5%, glycolic acid (AHA), caffeine, etc. for 24 weeks.
Main outcome variables
Count changes in terminal hair
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210130050179N6
Registration date:2023-02-12, 1401/11/23
Registration timing:prospective
Last update:2023-02-12, 1401/11/23
Update count:0
Registration date
2023-02-12, 1401/11/23
Registrant information
Name
Taraneh Yazdanparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
drtaraneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical investigation of the safety and effectiveness of Excilia Hair strengthening and ani hair loss Lotion in improving male pattern androgenic hair loss
Public title
Clinical investigation of the safety and effectiveness of Excilia Hair strengthening and ani hair loss Lotion in improving hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male aged 18-55 years
General health
Hair Loss Status II, III, IV Based on Norwood Scale
Voluntary participation and signing written informed consent
Exclusion criteria:
Chronic active scalp disease other than hair loss
Using any prescribed drug or OTC for hair loss within the past 3 months
Documented sensitivity to formulation components
Any severe weight loss or strict diet therapy during the study
Oral or topical treatment of minoxidil within 6 months before entering the study.
Age
From 18 years old to 55 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
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 The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor,The Institute of Pharmaceutical Sciences, Faculty of Pharmacy,16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-01-30, 1401/11/10
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.105
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
Count changes in terminal hair
Timepoint
Before intervention, 8,16,24 and 32 weeks after the start of use
Method of measurement
Trichoscopy By Fotofinder device
Secondary outcomes
1
Description
Hair count changes
Timepoint
Before intervention, 8, 16 and 32 weeks after the start of use
Method of measurement
Trichoscopy By Fotofinder device
2
Description
Hair lost Changes, based on Global photographic review
Timepoint
Before intervention, 8, 16 and 32 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.
Intervention groups
1
Description
Intervention group: Topically use of Excilia Hair strengthening and anti-hair loss lotion; Includes: Minoxidil oxathiazolidine carboxylate 5%, glycolic acid (AHA), caffeine, etc. for 24 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy