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IRCT20130911014630N5 IRCT 2019-04-21 Mazandaran University of Medical Sciences 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 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 2019-03-03 anticipated 45 Complete https://irct.ir/trial/37755 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization, individual, using random numbers table, 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. 3 . Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Results from clinical trials When: 6Month after print results To whom: for researchers working in Mazandaran University of Medical Sciences Conditions: Use of results is allowed only with the mention of the source Where to obtain: nazanin.yousefi.72@gmail.com How to obtain: 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
public nazanin yousefi
farah abad street
sari Iran (Islamic Republic of) 4847191971 +98 11 3354 2472 nazanin.yousefi.72@gmail.com Mazandaran University of Medical Sciences scientific dr mohammad azadbakht
farah abad street
sari Iran (Islamic Republic of) 4847191971 +98 11 3354 2472 azadbakhtm@hotmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) ‏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. 18 years 65 years Both 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. Prevention Prevention 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. 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. Prevention of complications after tattoo. Timepoint: At least twice a day for 3 days. Method of measurement: questionnaire. Mazandaran University of Medical Sciences Approved 2019-03-12 Ethics Committee of Mazandaran University of Medical Sciences farah abad street sari Mazandaran Iran (Islamic Republic of)