Investigating the effect of a product containing caffeine and rosemary essential oil (Rosmarinus officinalis) on reducing hair loss in patients with mild to moderate androgenetic alopecia
Investigating the effect of a product containing rosemary essential oil and caffeine on reducing hair loss in patients with mild to moderate androgenetic alopecia
Design
Clinical trial with parallel groups, without blinding, randomized, phase 3 on 60 patients, random permutation block method was used for randomization.
Settings and conduct
Patients will receive 1 CC of topical minoxidil 5% or product made of rosemary extract with caffeine, twice daily for men and once daily in women until 12 weeks in .
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Patients with androgenetic alopecia 2- Patients who want to participate in the study 3- Patients who are 15 to 45 years old. Exclusion criteria: 1- Patients with other types of alopecia 2- Patients with psoriasis or lichen planus 3- Patients with any serious systemic disease 4- Patients with photo-sensitivity 5- Patients with the history of hair transplant 6- Pregnant or Breast-feeding women 7- Patients with the history of ceffeine or rosemary sensitivity.
Intervention groups
Intervention group: Topical administration of product made of rosemary extract with caffeine. Control group: Topical administration of Minoxidil 5%
Main outcome variables
Hair density; hair thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150221021159N10
Registration date:2024-08-12, 1403/05/22
Registration timing:prospective
Last update:2024-08-12, 1403/05/22
Update count:0
Registration date
2024-08-12, 1403/05/22
Registrant information
Name
Shadi Farsaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2618
Email address
farsaei@pharm.mui.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a product containing caffeine and rosemary essential oil (Rosmarinus officinalis) on reducing hair loss in patients with mild to moderate androgenetic alopecia
Public title
Investigating the effect of rosemary essential oil and caffeine on reducing hair loss in patients with androgenetic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate androgenetic alopecia Patients who are between 15 and 45 years old. Patients who want to participate in the study and sign the informed consent form
Exclusion criteria:
Patients with other types of alopecia Patients with psoriasis or lichen planus Patients with serious systemic disease Patients with photosensitivity Patients with the history of hair transplant Pregnant or Breast-feeding women People with caffeine or rosemary allergy
Age
From 15 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with the permuted block method was used to create the random sequence in each group. At first, the specific internet software (https://www.sealedenvelope.com/simple-randomiser/v1/lists) was used to create the random series in blocks of 2, 4, and 6. Each block has an equal number of intervention and control groups. After that, created codes were written on the cards and placed respectively for hiding in locked opaque packets. A packet was selected for each patient according to the study recruitment, which determines the related study group.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-03-19, 1402/12/29
Ethics committee reference number
IR.MUI.PHANUT.REC.1402.090
Health conditions studied
1
Description of health condition studied
Androgenetic alopecia
ICD-10 code
L64.8
ICD-10 code description
Other androgenic alopecia
Primary outcomes
1
Description
Hair regrowth rate
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the study. Also, in case of desire and consent to continue the treatment after 24 weeks.
Method of measurement
Handy scope fotofinder Dermoscope device
Secondary outcomes
1
Description
Determination of density and thickness of hair
Timepoint
At the beginning of the study (before the start of the intervention) and 12 weeks after the start of the study. Also, in case of desire and consent to continue the treatment after 24 weeks.
Method of measurement
Handy scope fotofinder Dermoscope device
Intervention groups
1
Description
Intervention group: Intervention group: they are treated with the product made of onion and rosemary extract together with caffeine, twice a day. The duration of use is 12 weeks, but the treatment process in patients who have the desire and consent to continue the treatment will continue for 24 weeks.
Category
Treatment - Drugs
2
Description
Control group: Control group: with topical minoxidil 5% in the form of one cc, twice a day for men and once a day for women. The duration of use is 12 weeks, but the treatment process in patients who have the desire and consent to continue the treatment will continue for 24 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AL Zahra hospital
Full name of responsible person
Shadi Farsaei
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 7071
Email
sh.farsaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Isfahan university of medical sciences, Hezar jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8148614481
Phone
+98 31 3792 7071
Email
sh.farsaei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shadi Farsaei
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, Isfahan University of Medical Sciences, Hezar Jarib Avenue.
City
Isfahan
Province
Isfehan
Postal code
8148614481
Phone
+98 31 3792 7071
Fax
+98 31 3668 0011
Email
farsaei@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shadi Farsaei
Position
Pharm. D., BCPS
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avenue.
City
Isfahan
Province
Isfehan
Postal code
8148614481
Phone
+98 31 3792 7071
Fax
Email
sh.farsaei@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shadi Farsaei
Position
Pharm. D., BCPS / Academic member (associate professor)
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avenue.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7071
Fax
Email
farsaei@pharm.mui.ac.ir
Web page address
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