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IRCT20171222037987N1 IRCT 2018-06-30 Esfahan University of Medical Sciences Combination of Hydroquinone and Fractional CO2 Laser vs. Hydroquinone Monotherapy in Melasma Treatment: A Randomized Split-face Clinical Trial Comparison of Effectiveness of Hydroquinone 4% and Fractional CO2 Laser combination vs. Hydroquinone 4% Monotherapy in women from the age range of 20-50 years with melasma. 2015-02-04 anticipated 40 Complete https://irct.ir/trial/30125 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For each patient one cheek was considered as the control (Hydroquinone group) and the other cheek as the experiment (laser and Hydroquinone group) according to blocked randomization which was generated by a third independent person who was not involved in the study. Participants were randomized in to group A (right cheek as the experiment) and group B (left cheek as the experiment) within then blocks of four each. Randomly generated treatment allocations were concealed in the forty envelopes which were sequentially numbered and opened only after each patient was consented to enter the trial, Blinding description: the main investigators, data analysors and out come assessors were blinded. Severity of the melasma lesions was assessed objectively by the main investigator who was blinded to the treatment being given on each side and consultant dermatologist who was blinded to the type of treatments applied and aim of the study. Furthermore, response to treatment was evaluated subjectively by the main investigator and another consultant dermatologist who was blinded to the treatment being given on each side and the aim of the study. 3 melasma. Intervention 1: Intervention group: for each patient one side of the face was randomly allotted to topical hydroquinone 4% and Fractional CO2 laser (combination therapy group). Patients received three sessions of laser therapy at 3-week intervals with the Dios instrument. (Laser fluence of 5 J/cm2, Dot cycle of 6 and Pixel pitch of 2). Intervention 2: Control group: for each patient one side of the face was randomly allotted to topical hydroquinone 4% (monotherapy group). Hydroquinone 4% was applied during the study and maintained for 3 months after the last laser session. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information
public Farahnaz Fatemi Naeini
Department of Dermatology, Alzahra Hospital, Soffe Blvd, Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2087 fatemi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Farahnaz Fatemi Naeini
Department of Dermatology, Alzahra Hospital, Soffe Blvd, Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2087 fatemi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Female patients Age range of 20-50 years Fitzpatrick skin types II-V Bilateral melasma on cheeks 20 years 50 years Female History of receiving laser therapy and topical therapeutic agents in the previous three months History of receiving Isotretinoin in the past six months History of receiving OCP, other bleaching creams, phenytoin, phototoxic and photoallergic drugs Pregnancy Lactating L81.1 Chloasma Treatment - Drugs Treatment - Drugs Intervention group: for each patient one side of the face was randomly allotted to topical hydroquinone 4% and Fractional CO2 laser (combination therapy group). Patients received three sessions of laser therapy at 3-week intervals with the Dios instrument. (Laser fluence of 5 J/cm2, Dot cycle of 6 and Pixel pitch of 2). Control group: for each patient one side of the face was randomly allotted to topical hydroquinone 4% (monotherapy group). Hydroquinone 4% was applied during the study and maintained for 3 months after the last laser session. Severity of the melasma lesions was assessed objectively based on Darkness (D) and Homogeneity (H) using a 7-point scale (0-6). Timepoint: The darkness and homogeneity scores were obtained in the first visit and the 3 laser sessions at three-week intervals and the follow-up sessions at 1 and 3 months after the last laser session. Method of measurement: darkness and homogeneity : 7-point scale(compare with the sample) patient's satisfaction with the treatment :visual analogue scale (VAS) by scoring between 0 and 10 response to treatment : physician global assessment. Patient's satisfaction with the treatment. Timepoint: 3 months after the last laser session. Method of measurement: visual analogue scale (VAS) by scoring between 0 and 10. Esfahan University of Medical Sciences Approved 2013-01-20 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical sciences, Hezar Jerib Ave Isfehan Isfehan Iran (Islamic Republic of)