MedPath

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

Phase 3
Conditions
.
Registration Number
IRCT20130911014630N5
Lead Sponsor
Sari University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
45
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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Prevention of complications after tattoo. Timepoint: At least twice a day for 3 days. Method of measurement: questionnaire.
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath