Protocol summary

Study aim
‏Effect of lipogel containing Arnebia euchroma - Calendula officinalis -Zataria multiflora and sesame oil on skin restoration complications after tattoo
Design
The total sample size is 45, of which half are in the gentamicin group and half of the lipogel group. A diagnosis of a patient is done with a study by a dermatologist.Triple blind study. People should not have skin diseases such as vitiligo, burns and so on. The use of any skin-related product during treatment is under the supervision of a dermatologist
Settings and conduct
A study in the skin and hair clinic under the supervision of Dermatologist Dr. Rahmatpour. Coded products are randomly assigned to patients
Participants/Inclusion and exclusion criteria
‏Inclusion ceriteria:Admission age ‏between the ages of 18 and 65, a person with full skin health, menopause or those undergoing sterilization surgery is advised by the doctor; tattoo size is less than 30 cm. ‏Exclusion ceriteria:Age over 65 or under 18; pregnant woman; people with skin diseases such as vitiligo, yellow, burn etc; tattoo size greater than 30 cm
Intervention groups
The study consists of two groups of control and drug recipients. The lipogel group received the extract containing the drug and the control group received gentamicin. The lipogel and the gentamicin are twice daily rubbed over to the entire eyelid and not repaired for 1 hour.
Main outcome variables
Study of complications after tattoo by lipogel compared to gentamicin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130911014630N5
Registration date: 2019-04-21, 1398/02/01
Registration timing: retrospective

Last update: 2019-04-21, 1398/02/01
Update count: 0
Registration date
2019-04-21, 1398/02/01
Registrant information
Name
Mohammad Azadbakht
Name of organization / entity
Mazandaran University of Medical Scinecee
Country
Iran (Islamic Republic of)
Phone
+98 15 1214 4052
Email address
mazadbakht@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-03, 1397/12/12
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Arnebia euchroma - Calendula officinalis -Zataria multiflora and sesame oil lipogel formulation on post- tattoos complication prevention of in comparison to gentamicin:a randomized clinical trial
Public title
Evaluation of the effect of Arnebia euchroma - Calendula officinalis -Zataria multiflora and sesame oil lipogel formulation on post- tattoos complication prevention of in comparison to gentamicin:a randomized clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
‏Age of admission is between 18 and 65 years,‏The tattoos should not be larger than 12 inches;‏The tattoos must be dressed or bandaged and not exposed to sunlight, otherwise you should use an anti-sun lamp with a spf above 50;‏Individuals should be inclined to take digital photographs of the area they are able to reach for educational and scientific purposes;‏Not pregnant people;‏Menopause or who have undergone sterilization surgery can attend a doctor's review.
Exclusion criteria:
Participation in a clinical trial of a drug or another device in the target area within 3days prior to enrollment or during the study.• History of allergic reaction to pigments following tattooing.• History of allergy to local anesthetics.• History of allergy to topical antibiotics.• History of malignant tumors in the target area.• Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.• Pregnant and/or breastfeeding.• Having an infection, dermatitis or a rash in the treatment area.• Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.• Suffering from coagulation disorders or taking prescription anticoagulation medications.• History of keloid scarring, hypertrophic scarring or of abnormal wound healing.• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.• History of vitiligo, eczema, or psoriasis.• History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.• History of seizure disorders due to light.• Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.• History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen• History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.• Systemic use of corticosteroid or isotretinoin within 3days of study participation.• Current smoker or history of smoking within 3days of study participation.• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual, using random numbers table
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the dermatologist and the patients and the investigator have no information about gentamicin or lipogel, and the product has predetermined codes and is given randomly to patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
farah abad street
City
sari
Province
Mazandaran
Postal code
4847191971
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.MAZUMS.RIB.REC.1398.001

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Prevention of complications after tattoo
Timepoint
At least twice a day for 3 days
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The lipogel containing extract is used twice daily to cover the entire eyebrow. For this purpose, 23 patients are selected according to the conditions of entry requirements. These people receive lipogel medications containing 5% of the extract ‏Arnebia euchroma ,2%of the extract ‏Calendula officinalis,3%of extract ‏Zataria multiflora,20% of sesame oil for three days under supervision of a dermatologist and in collaboration with the project implementer. To make 100 grams of lipogel, 10 grams of polyethylene and 90 grams of paraffin are used. Extract of ‏Arnebia euchroma,‏ Calendula officinalis-Zataria multiflora and sesame oil, is expected to have an effect on inflammation, scar tissue and scaling, which can improve the damaged skin. Should not be showered until 12 hours after use. This lipogel was made at the laboratory of the Mazandaran-Sari Pharmaceutical Faculty.
Category
Prevention

2

Description
Control group: Includes gentamicin from the pharmacy, that is spilled in lipogel's tubes and can not be identified, and the codes inserted on the product is the only way to identify. Twice daily, the eyebrows should be completely covered with the lipogel and Do not shower until 12 hours after use.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
کلینیک پوست و مو دکتر رحمت پور
Full name of responsible person
dr rahmatpour
Street address
farhang street
City
sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 2472
Email
nazanin.yousefi.72@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sari University of Medical Sciences
Full name of responsible person
dr mohammad azadbakht
Street address
farah abad street
City
sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 2472
Email
azadbakhtm@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Sari University of Medical Sciences
Full name of responsible person
nazanin yousefi
Position
Pharmacy student of Sari University of medical sciences
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
farah abad street
City
sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 2472
Email
nazanin.yousefi.72@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sari University of Medical Sciences
Full name of responsible person
dr mohammad azadbakht
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
farah abad street
City
sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 2472
Email
azadbakhtm@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sari University of Medical Sciences
Full name of responsible person
nazanin yousefi
Position
Pharmacy student of Sari University of medical sciences
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
farah abad street
City
sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 21 2624 3467
Email
nazanin.yousefi.72@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
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
Results from clinical trials
When the data will become available and for how long
6Month after print results
To whom data/document is available
for researchers working in Mazandaran University of Medical Sciences
Under which criteria data/document could be used
Use of results is allowed only with the mention of the source
From where data/document is obtainable
nazanin.yousefi.72@gmail.com
What processes are involved for a request to access data/document
Request from the researcher
Comments
If you have sufficient conditions and check the request of people who want to buy the project, they will be examined
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