The effect of faba bean extract on reduction of hairs of axilla
Design
clinical trial with control group, Blinded, randomized, the site www.Randomaize.com has been used for randomization.
Settings and conduct
This study is being performed in Emamreza and Quaem hospitals affiliated to Mashhad university of medical sciences.How to study the topical application of the cream containing faba bean extract in one side axilla and the use of placebo in the axilla on the opposite side twice a day in 19female volunteers aged 15 years or older and take pictures of both areas beforethe the intervention and monthly at the end of each month with a tricycle or camera and compare the two sides after three months and also according to the personal judgment of the candidates using the prepared checklists. Blinding is done by people under study ، evalutors and analysts.patients fall into two categories ، according to a random assignment made by Exel software or a randimization site.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Women 15 years of age and older who want to use this method to reduce unwanted hair in the area of the axilla.
Candidates who do not have a history of using laser in the axilla .
Non-entry criteria: Existence of skin disease in the area of axilla ,such as dermatitis and infectious and fungal diseases.
scarring in the area of the axilla.
G6PD deficiency in the test taken from people before the intervention.
pregnant women
Breastfeeding women
Intervention groups
Investing the effect of faba bean extract on the reduction of one-sided axilla hair in women 15 years and older and comparing it with placebo in axilla on the opposite side of the same people.
Main outcome variables
The condition of hair loss in the area of the axilla and the examination of the density and thickness of the hair by tricoscopy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047020N1
Registration date:2020-06-26, 1399/04/06
Registration timing:registered_while_recruiting
Last update:2020-06-26, 1399/04/06
Update count:0
Registration date
2020-06-26, 1399/04/06
Registrant information
Name
Fereshteh Zamiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3601 4909
Email address
zamirif971@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of faba bean extract on reduction of hairs of axilla and Comparison with control group
Public title
The effect of faba bean extract on reduction of hairs of axilla
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women 15 years of age and older who want to use this method to reduce unwanted hair in the area of the axilla.
Candidates who do not have a history of using laser in the axilla .
Exclusion criteria:
Existence of skin disease in the area of axilla ,such as dermatitis and infectious and fungal diseases.
scarring in the area of the axilla.
G6PD deficiency in the test taken from people before the intervention.
pregnant women
Breastfeeding women
Age
From 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
19
Randomization (investigator's opinion)
Randomized
Randomization description
According to the random allocation made by Excel software or the randomization site, patients fall into two categories(even/odd code or A/B code).
one of the codes will be set to the right of the intervention axilla ,the left axilla of the placebo ,and the other code will be set to the right of the placebo ,the left of the intervention.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Each volunteer is given two containing bean extract and the other placebo.
neither the study person nor the evaluator is aware of the content of either of the two containers. the vessels are similar and it is not clear in which placebo and in which intervention.
Placebo
Used
Assignment
Parallel
Other design features
Evaluation of slow growth of hair in the axilla area is done monthly and 4 times (before the start of the intervention and then monthly for up to 3 months). by taking a photo with a Dermoscope or thrichoscope or take photos with high resolution cameras(In each individual, the axilla of one side is always intervention and the oppsite axilla is always control) and comparing the axilla of both sides in each person
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of Medical Sciences
Street address
Vice chancellor for research and technology، Mashhad university،In frot of Daneshgah 18st، Daneshgah18، Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2019-12-05, 1398/09/14
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.023
Health conditions studied
1
Description of health condition studied
Reduce axilla hair with faba bean extract
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Axilla hair
Timepoint
Take a photo of the axilla area at the beginning of the study (Before starting the intervention) and 1,2and 3month after using the local bean extract.
Method of measurement
thricoscope or camera(If it is not possible to use thricoscope)
Secondary outcomes
empty
Intervention groups
1
Description
In this study ،the effect of bean extract on reducing the thickness and number of hairs in the axilla area will be investigated. 19 women 15 years and older who wish to participate in the study if they are not pregnant or breastfeeding ، have no history of laser use in this area ، have no inflammatory and infectious diseases and scar in this area and have no ٖٖٖG6PD enzyme deficiency enter the study and for 3 month of bean extract with a concentration of 20% in combination with base cream twice a day، one gr at a time، on one side and base cream is used as a placebo on the opposite side. And at the beginning of the study and at the end of each month for 3 months after three days of not shaving the hair of the erea ، both axillas are photographed with a tricoscope or camera. and at the end of the study، using a checklist of volunteers and photos taken ، the number and thickness of hair in two axillas per person will be compared .The cream containing bean extract is made in Mashhad medical sciences laboratory under the supervision of the relevant pharmacist.
Category
Other
2
Description
Control group:In this study ,each person under study also has their own control.In exile, one side of the bean extract is used, and the opposite exile, the Base cream is used as a placebo as a control.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza hospital
Full name of responsible person
Dr. Masood Maleki
Street address
Emam reza hospital، Daneshgah st، Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۳۷۹۱۳۳۱۶
Phone
+98 51 3858 3845
Email
Emamreza@mums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Quaem hospital
Full name of responsible person
Dr. Masood Maleki
Street address
ٖٖٖٖٖٖٖٖٖٖٖٖٖQuaem hospital، Ahmad abad st، Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۶۶۹۹۱۹۹
Phone
+98 51 3801 2493
Email
Quaem.Medical.center@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Medical univercity، ِAzadi square، Vakilabad st
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2518
Email
MalekiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?