Protocol summary

Study aim
Preparation and evaluation of glycyrrhizin-menthol-aloe vera topical gel and its effectiveness in preventing laser-induced dermatitis: a randomized controlled clinical trial
Design
A randomized controlled clinical trial with double-blind parallel groups of phase 2 is on 90 patients, and the patients will be randomly divided into 3 groups of 30 people based on the RAND() function of Excel software.
Settings and conduct
This study is a randomized clinical trial that is conducted on 90 patients at Yazd Laser Therapy Center. Taking into account the criterion of entering the study, the clients will be randomly divided into 3 groups of 30 people, including those receiving glycyrrhizin-menthol-aloe vera gel, placebo (base gel) or control (without medicine). Neither the doctor nor the patient knows the contents of the medicine containers
Participants/Inclusion and exclusion criteria
Clients who have started using laser and have no history of allergies to plants such as licorice, aloe vera and mint and no skin diseases
Intervention groups
The group receiving glycyrrhizin, aloe vera, and menthol gel, which was made in the laboratory of the Faculty of Pharmacy of Yazd University of Medical Sciences under the supervision of the professors of the faculty and during the Ph.D. thesis of a pharmacy student, received topically for 15 days from the start of the laser. The control group received base gel without medication for 15 days from the start of the laser
Main outcome variables
at times 1, 2, 4, 7, 10, 15, the state of the laser site in terms of the loss of the epidermis, intensity of redness, dryness, itching (based on the table below), burning and pain (based on the visual scale VAS) and the patient's satisfaction with the use of the drug and whether the skin in the laser area gets second degree burns or not and the need to use standard dermatitis treatment are evaluated.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191106045356N17
Registration date: 2023-07-24, 1402/05/02
Registration timing: registered_while_recruiting

Last update: 2023-07-24, 1402/05/02
Update count: 0
Registration date
2023-07-24, 1402/05/02
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and evaluation of topical glycyrrhizin-menthol-aloe vera gel and assessment its effect on the prevention of laser-induced dermatitis: a randomized controlled clinical trial
Public title
Evaluation of the effect of glycyrrhizin hydrogel on laser burns
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Clients starting to use laser Clients aged 18 to 55 years No history of licorice allergy Absence of severe systemic disease such as uncontrolled diabetes, epilepsy, immune system deficiency, etc. Willingness to participate in the study and complete the ethical consent form
Exclusion criteria:
Clients with skin disease Allergy to glycyrrhizin or any of the compounds used Exacerbation of dermatitis or 2nd degree burns Non-cooperation of the volunteer in using medicine for more than one day
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized clinical trial that is conducted on 60 patients at Yazd Laser Therapy Center. Taking into account the inclusion criteria, the participants will be randomly placed in three groups of 20 people including glycyrrhizin gel recipient, gel base, and control (without receiving any medication), and will receive the drug related to that group, based on the RAND() function of Excel software. The medicine is placed in uniform containers, and neither the doctor nor the participant knows about the contents of the tubes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, clients who have undergone laser hair removal will be included in the study after obtaining written consent. Taking into account the inclusion criteria, the clients will be placed in 3 groups of 30 people including glycyrrhizin-menthol-aloe vera gel, placebo (base gel) or control (without medicine) based on the random numbers table. They will use the prescribed medicine twice a day under the supervision of a doctor. Neither the doctor nor the patient knows the contents of the medicine containers. After the start of the treatment at times 1, 2, 4, 7, 10, 15, the state of the laser site in terms of the loss of the epidermis, intensity of redness, dryness, itching (based on the table below), burning and pain (based on the visual scale VAS) and the patient's satisfaction with the use of the drug and whether the skin in the laser area gets second degree burns or not and the need to use standard dermatitis treatment are evaluated
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
1234567890
Approval date
2023-01-11, 1401/10/21
Ethics committee reference number
IR.SSU.MEDICINE.REC.1401.184

Health conditions studied

1

Description of health condition studied
Laser induced dermatitis
ICD-10 code
L59.8
ICD-10 code description
Other specified disorders of the skin and subcutaneous tissue related to radiation

Primary outcomes

1

Description
Grading the intensity of skin redness
Timepoint
After starting treatment at times 1, 2, 4, 7, 10, 15
Method of measurement
The condition of the laser site in terms of the loss of the epidermis, the intensity of redness, dryness, itching, burning, and pain (based on the visual analog scale), and the patient's satisfaction with the use of the drug, and that the skin of the laser area has undergone second-degree burns. are evaluated or not, as well as the need to use the standard treatment of dermatitis.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The recipient of glycyrrhizin-menthol-aloe vera gel will use the prescribed medicine twice a day under the supervision of a doctor. In this study, clients who have undergone laser hair removal will be included in the study after obtaining written consent. Taking into account the criterion of entry into the study, the clients will be placed in 3 groups of 30 people including glycyrrhizin-menthol-aloe vera gel (prepared at the Faculty of Pharmacy of Yazd University of Medical Sciences under the supervision of the professors of the faculty and as a doctoral thesis of a pharmacy student), placebo (base gel) or control (without medicine). Twice a day and for 15 days under the supervision of a doctor, they will use the prescribed medicine topically. Neither the doctor nor the patient knows the contents of the medicine containers. After starting the treatment at times 1, 2, 4, 7, 10, 15, the condition of the laser site in terms of the loss of the epidermis, the intensity of redness, dryness, itching (based on the table below), burning and pain (based on the visual analog scale), and the patient's satisfaction with the use of the drug, and whether the skin of the laser area is subject to second-degree burns or not, and the need to use standard dermatitis treatment, are evaluated.
Category
Prevention

2

Description
Control group: Placebo (base gel) or control (without medicine) which is filled in tubes like medicine.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Laser Center
Full name of responsible person
Fatemeh Dehghani
Street address
Yazd city, Alem Square, Shahid Sadougi Faculty of Pharmacy
City
Yazd
Province
Yazd
Postal code
1234567890
Phone
+98 913 776 2437
Email
fatemehdehqani978@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amin Salehi
Street address
Alem square
City
Yazd
Province
Yazd
Postal code
1234567890
Phone
+98 913 776 2437
Email
fatemehdehqani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Dehghani
Position
Pharmacy Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy , Yazd , Alem square
City
Yazd
Province
Yazd
Postal code
1234567890
Phone
+98 913 776 2437
Email
fatemehdehqani978@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Dehghani
Position
Pharmacy Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Yazd, Alam Square
City
Yazd
Province
Yazd
Postal code
1234567890
Phone
+98 913 776 2437
Email
fatemehdehqani978@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
1234567890
Phone
+98 35 3820 3865
Email
mzabihi100@gmail.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only a part of the data, such as the information related to the main outcome or the like, can be shared.
When the data will become available and for how long
One year after the time of publication
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data will be available only to researchers working in academic and scientific institution
From where data/document is obtainable
The data will only be available to researchers working in academic and scientific institutions through the following email address. neginaseri@yahoo.com
What processes are involved for a request to access data/document
Only the data related to the main results of the study can be presented to the mentioned people after mentioning the valid reason.
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