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IRCT20200701047976N1 IRCT 2020-07-14 Shiraz University of Medical Sciences Effect of Hypochlorite Sodium 0.005% in treatment of Acne Hypochlorite Sodium 0.005% versus placebo in treatment of mild to moderate Acne; A randomized double blind clinical control 2020-07-22 anticipated 40 Complete https://irct.ir/trial/49339 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We used block randomization method. Our sample includes 40 patients which was divided into 10 blocks with 4 patients in each one. With random number table, our sample was divided into A and B groups and the data was written on the paper and randomizatin was done by random number table manually. Group A received Hypochlorite sodium 0.005% on the right side of their face and group B received that on the left side of their face; concurrently, group A received placebo on the left side of their face and group B received that on the right side of their face, Blinding description: Although Hypochlorite Sodium and placebo(distilled water) were both put into the same white bottles; each bottle has specific code showing its content. Only the pharmacist is aware about these codes. During study, both dermatologist and patients were blind about using Hypochlorite sodium and placebo on each side of patients' faces. 2-3 Acne Vulgaris. Intervention 1: Intervention group: Solution of Hypochlorite sodium 0.005% was prepared by pharmacist from Hypochlorite sodium 6%. In this study, the concentration of solution was determined according to the formulation used in previous studies. On the other hand, higher concentrations increase the possibility of skin damage. Although Hypochlorite sodium and placebo(distilled water) were both put into the same white bottles; each bottle has specific code showing its content. Only the pharmacist is aware about these codes. The patients received Hypochlorite sodium 0.005% administered topically on the right or left side of their face three times a day for one month. Hypochlorite sodium 0.005% was applied randomly on each side of the patients' faces. The patients were not aware of the type of solution (placebo or Hypochlorite sodium 0.005%) applied for them.In addition to patients, dermatologist and the recorder person were both blind about the solution applied for each side of patient's face. Intervention 2: Control group: The patients received placebo(distilled water)administered topically on the right or left side of their faces three times a day for one month.The placebo was applied randomly on each side of the patients' faces. The patients were not aware of the type of solution (placebo or Hypochlorite sodium 0.005%) applied for them.In addition to patients, dermatologist and the recorder person were both blind about the solution applied for each side of patient's 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 There is no more information.
public Maryam Hadibarhaghtalab
Maryam Barhaghtalab (Seifi), 2nd Floor, 143 Plaque, Zanbagh 9 Alley, Farhangshahr Blvd
Shiraz Iran (Islamic Republic of) 7137954999 +98 71 3622 3919 Maryam_hadibarhaghtalab@yahoo.com Shiraz University of Medical Sciences scientific Maryam Hadibarhaghtalab
Maryam Barhaghtalab (Seifi), 2nd Floor, 143 Plaque, Zanbagh 9 Alley, Farhangshahr Blvd
Shiraz Iran (Islamic Republic of) 7137954999 +98 71 3622 3919 Maryam_hadibarhaghtalab@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with mild to moderate Acne Vulgaris diagnosed by dermatologist no limit no limit Both Patients with symptoms such as secondary Acne caused by lactation Dermatology condition in addition to Acne Patients who had taken drugs such as Isotretinoin or systemic/topical antibiotics within the last two months Allergy to Hypochlorite Sodium L70.0 Acne vulgaris Treatment - Drugs Placebo Intervention group: Solution of Hypochlorite sodium 0.005% was prepared by pharmacist from Hypochlorite sodium 6%. In this study, the concentration of solution was determined according to the formulation used in previous studies. On the other hand, higher concentrations increase the possibility of skin damage. Although Hypochlorite sodium and placebo(distilled water) were both put into the same white bottles; each bottle has specific code showing its content. Only the pharmacist is aware about these codes. The patients received Hypochlorite sodium 0.005% administered topically on the right or left side of their face three times a day for one month. Hypochlorite sodium 0.005% was applied randomly on each side of the patients' faces. The patients were not aware of the type of solution (placebo or Hypochlorite sodium 0.005%) applied for them.In addition to patients, dermatologist and the recorder person were both blind about the solution applied for each side of patient's face. Control group: The patients received placebo(distilled water)administered topically on the right or left side of their faces three times a day for one month.The placebo was applied randomly on each side of the patients' faces. The patients were not aware of the type of solution (placebo or Hypochlorite sodium 0.005%) applied for them.In addition to patients, dermatologist and the recorder person were both blind about the solution applied for each side of patient's face. Evaluation of Acne remission on the basis of changes in the number of Papules and Pustules. Timepoint: Initiation of study(before starting the treatment), 14 days and 28 days after starting the treatment. Method of measurement: Counting the number of Papules and Pustules. Shiraz University of Medical Sciences Approved 2018-12-31 Ethics committee of Shiraz University of Medical Sciences School medicine of Shiraz, Emam Hosein Square, Zand Blvd Shiraz Fars Iran (Islamic Republic of)