Clinical evaluation of the brightening effect of Licorice (Glycyrrhiza glabra) and Cidr (Ziziphus spina-christi) mask on the skin in young people volunteering: The double-blind, randomized, placebo-controlled trial
Achieving a suitable formulation for the production of a facial mask containing Licorice and Cidr extract with a certain percentage and evaluating the effect of the product on brightening skin blemishes
Design
A controlled clinical trial with randomized, double-blind, parallel groups was performed on 48 patients. Random data function in mini-tab software is used for randomization.
Settings and conduct
This study is performed on people aged 18-50 years with any type of blemish such as pimples or sun spots referred to Imam Khomeini Hospital in Ahvaz. Randomization sequence of patients is performed using random numbers generated by Mini-tab software. Each person is given a tube containing a placebo or therapeutic mask, and a photograph of the face is taken monthly. The mask is applied twice a week for 2 months and is peeled off after 15 minutes.Three questionnaires related to the organoleptic properties and effect of the mask and psychological questions will be provided for monthly evaluation.
Participants/Inclusion and exclusion criteria
All women aged 18-50 years who have any hyper-pigmentation on the skin of their face and have signed a personal consent form, and are not pregnant, breastfeeding or using skin brightening products or oral contraceptives or sensitive to the product's ingredients.
Intervention groups
The main mask (medicine) is a peel off mask containing 12.6% Licorice extract and 5% Cidr extract.
The placebo mask is a peel off mask that contains all the raw materials in the main mask except Licorice and Cidr extract, and in order to create a color and smell similar to the original mask, a combination of edible dyes and permitted essential oils has been added to it. .
Main outcome variables
Questionnaire of organoleptic properties of the mask; Questionnaire
of the Brightening Effect on the Skin; Psychological Questionnaire; Photo of skin before and after applying the mask
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200128046288N6
Registration date:2022-06-25, 1401/04/04
Registration timing:retrospective
Last update:2022-06-25, 1401/04/04
Update count:0
Registration date
2022-06-25, 1401/04/04
Registrant information
Name
Fereshteh Golfakhrabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8378
Email address
golfakhrabadi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-26, 1401/03/05
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the brightening effect of Licorice (Glycyrrhiza glabra) and Cidr (Ziziphus spina-christi) mask on the skin in young people volunteering: The double-blind, randomized, placebo-controlled trial
Public title
Formulation and clinical evaluation of the brightening effect of Licorice and Cidr mask on the skin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people who have anykind of hyper-pigmentation (acne spot- sunspot -...) with any degree.
Willingness to participate in the study and signing the consent form
Exclusion criteria:
Pregnancy
Breastfeeding
Treatment with hormonal drugs and oral contraceptives
Infection or skin disease at the study site
Use of other lightening products in the last 6 months
Inability to attend monthly visits
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients is done using random numbers generated by the computer and Mini-tab software by Random data option. In this way, the people under study are numbered from 1 to 48 and then the software selects 24 random numbers from 1 to 24. These random numbers will be the number of people receiving tubes containing the mask, and 24 other patients receiving tubes containing placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the placebo mask (which is completely similar to the original mask in terms of color and smell) and the main mask are coded and labeled A or B by a third party (who does not participate in the study). The subjects and the researcher only know the mask code and do not know the type of mask.The placebo mask is quite similar to the original mask in terms of color, smell and tube shape.
Evaluation and analysis of data is done by the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences,, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.AJUMS.REC.1401.059
Health conditions studied
1
Description of health condition studied
Skin hyperpigmentation
ICD-10 code
L81.4
ICD-10 code description
Other melanin hyperpigmentation
Primary outcomes
1
Description
Degree of skin hyperpigmentation
Timepoint
Before the intervention, the first month and the second month after using the mask
Method of measurement
Self-assessment questionnaire on the effect of the mask on the skin, photos before and after using the product
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Peel off face mask of 12.6% Licorice extract and 5% Cidr extract will be made by the researchers of the present project and based on reliable sources. The mask is applied to the skin twice a week for 15 minutes and then washed off. This product was used for two months.
Category
Treatment - Drugs
2
Description
Control group: The placebo mask will be made by the researchers of the present project and based on reliable sources. The mask is applied to the skin twice a week for 15 minutes and then washed off. This product was used for two months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Freshteh Golfakhrabadi
Street address
Ahvaz Jundishapur University of Medical Sciences,, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311 0000
Email
golfakhrabadi-f@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghaddam
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 6333 4142
Email
golfakhrabadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fereshteh Golfakhrabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Email
golfakhrabadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fereshteh Golfakhrabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Email
golfakhrabadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fereshteh Golfakhrabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8378
Email
golfakhrabadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Deidentified individual participant data of study, study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code, data dictionary will be shared after the study.
When the data will become available and for how long
The access time is up to 6 months after the results are published
To whom data/document is available
Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis
Under which criteria data/document could be used
Six months after the publication of articles from this study, the data obtained will be made available to the applicant researchers for further analysis.
From where data/document is obtainable
Applicants can email the responsible author to receive the requested data golfakhrabadi@yahoo.com
What processes are involved for a request to access data/document
Applicants will have access to the data from the present study by emailing the responsible author for up to one month. golfakhrabadi@yahoo.com