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IRCT20140212016557N11 IRCT 2023-07-31 Shiraz University of Medical Sciences Assessing the effect of brimonidine gel on the redness remained after pimples Comparison of the effect of Brimonidine 0.33% gel and placebo on the clinical erythema score in post-acne erythema patients 2023-08-23 anticipated 30 Complete https://irct.ir/trial/69282 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are recruited by consecutive sampling in the study. Randomization is performed by random allocation software and participants are randomly allocated in the intervention or control group. Randomization of 30 participants in the software is performed by randomization blocks size 4 with random ratio of 1:1. The output of the software is a table that shows the number of each participant is allocated in the intervention or control group. The medications are in the similar containers labeled by numbers of the patients, Blinding description: All drugs are packed in similar containers and have similar color, smell, and texture; and, the containers allocated to each patient are labelled with the same patients of patient recruitment number. Care provider and investigator that deliver the gels are not involved in the outcome assessment. The outcome assessor is not aware of the type of drugs in each patient. Due to similarity of the drugs and the instructions, the patients are also unaware of the type of used drugs. Therefore the research will be double-blinded. 3 Post-acne erythema. Intervention 1: Intervention group: Brimonidine 0.33% gel (Janus, Tehran, Iran) is applied once overnight on the face. Intervention 2: Control group: Lubricant gel (Razak, Tehran, Iran) is applied once overnight on the face. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Possibility of loss of confidentiality
public Mozhdeh Sepaskhah
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 1433671348 +98 71 3212 5239 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences scientific Mozhdeh Sepaskhah
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 1433671348 +98 71 3212 5239 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients between 18 and 45 years of age Post-acne erythema after successful treatment of acne vulgaris 18 years 45 years Both pregnancy lactation depression cerebral or coronary artery insufficiency Raynaud’s phenomenon orthostatic hypotension thromboangiitis obliterans scleroderma Sjögren’s syndrome severe or unstable cardiovascular disease L70.8 Other acne Treatment - Drugs Treatment - Drugs Intervention group: Brimonidine 0.33% gel (Janus, Tehran, Iran) is applied once overnight on the face. Control group: Lubricant gel (Razak, Tehran, Iran) is applied once overnight on the face. Clinician score of post-acne erythema. Timepoint: Before intervention, 4 and 8 weeks after starting intervention, and 1 months after treatment cessation. Method of measurement: 5-point clinical score, defined as: 0=clear with no erythema, 1 = almost clear or slight redness, 2 = mild or definite redness, 3 = moderate or marked redness, 4 = severe or fiery redness. Skin erythema index. Timepoint: Before intervention, 4 and 8 weeks after starting intervention, and 1 months after treatment cessation. Method of measurement: Dermacatch instrument. Patient self-assessment of post acne erythema treatment. Timepoint: 4 and 8 weeks after starting intervention, and 1 months after treatment cessation. Method of measurement: 4-point patient assessment of treatment result expressedas: a. No improvement, b. Mild improvement, c. Good improvement, d. Excellent improvement. Quality of life. Timepoint: before intervention and 1 months after cessation of treatment. Method of measurement: Dermatology Life Quality index questionnaire Persian version. Shiraz University of Medical Sciences Approved 2023-04-30 Ethics committee of Shiraz University of Medical Sciences Shiraz University of MedicalSscience, zand Ave. Shiraz Fars Iran (Islamic Republic of)