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IRCT2014080218648N1 IRCT 2014-10-11 Isfahan University of Medical Sciences Efficacy of Platelet Rich Plasma and fractional co2 laser in treatment of acne scar of face PRP:Platelet Rich Plasma Comparison of efficacy of Autologous Platelet Rich Plasma Combined with Ablative Carbon Dioxide Fractional Resurfacing laser vs Ablative Carbon Dioxide Fractional Resurfacing laser alone in Acne scar treatment 2014-09-06 anticipated 32 Complete https://irct.ir/trial/16844 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A acne scar. Intervention 1: 20cc patient blood will be taken and mixed with anticoagulant in a ratio of 1:10 (anticoagulant/blood). The mixture will then be centrifuged at a speed of 2,000 rpm for 3 minutes and the residue will be centrifuged again with concentration kit for 5 minutes at 5,000 rpm. 4cc PRP will finally be obtained. The PRP is to be obtained using a commercially available two-part system (Prosys PRP, T•Cell Bio Inc., Seoul, South Korea ) and mycells kit produced by South Korea. One side of the face (scar site) will receive 0.2mL of PRP at 2cm interval immediately after laser treatment. Participants will then be instructed to compress their faces with gauze for 15 to 20 minutes. Control group: The other side of the face(scar site), will receive 0.2mL of normal saline at 2cm interval on the scar site immediately after laser treatment. Participants will be instructed to compress their faces with gauze for 15 to 20 minutes. Intervention 2: Intervention group:The intended procedure is to be a pass of ablative fractional co2 laser – a setting of laser power: 25, dot cycle (duration): 3, energy: 30 mj, pixel pitch: 1, and ablation depth: 600 µm -on one side of the face. Control group: The intended procedure is to be, in similar fashion to the intervention group, a pass of ablative fractional co2 laser – a setting of laser power: 25, dot cycle (duration): 3, energy: 30 mj, pixel pitch: 1, and ablation depth: 600 µm- on the other side of the face.
public Dr shima keyvan
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences . Isfahan
Isfahan Iran (Islamic Republic of) +98 31 3664 2119 sh.kayvan7@gmail.com Skin Diseases and leishmaniasis research Center, Isfahan University of Medical Sciences, Isfahan, Ir scientific Dr Gita Faghihi
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences . Isfahan
Isfahan Iran (Islamic Republic of) +98 31 3663 3061 g_faghihi@med.mui.ac.ir Skin Disease and Leishmaniasis Research Center Isfahan University of Medical Sciences . Isfahan Is Iran (Islamic Republic of) Inclusion criteria: 1.Patients who have polymorphic and mixed acne scar (dominantly rolling and boxcar types ,less than ٪20 ice pick type and no hypertrophic or keloid type) 2.Patients who dont have other skin disease 3.Patients who have skin types 3-5 in fitzpatrick scale 4. Willingness for participation in the study and signing the consent form. Exclusion criteria:1.Known allergic reaction to components of study treatment that leads to unfinished study 2.Patient is unwilling to continue the study 3.Co-treatment with other methods 4.History of keloid formation 5.Any kind of active inflammation 6. Oral isotretinoin use within the preceding 6 months 7. Diabetes, collagen vascular disease 8. Ablative or nonablative laser skin resurfacing within the preceding 12 months, 9.Pregnancy or lactation 10.If patient doesnt follow the study . no limit no limit Both L90.5 scar cndition and fibrosis of skin Other Treatment - Devices 20cc patient blood will be taken and mixed with anticoagulant in a ratio of 1:10 (anticoagulant/blood). The mixture will then be centrifuged at a speed of 2,000 rpm for 3 minutes and the residue will be centrifuged again with concentration kit for 5 minutes at 5,000 rpm. 4cc PRP will finally be obtained. The PRP is to be obtained using a commercially available two-part system (Prosys PRP, T•Cell Bio Inc., Seoul, South Korea ) and mycells kit produced by South Korea. One side of the face (scar site) will receive 0.2mL of PRP at 2cm interval immediately after laser treatment. Participants will then be instructed to compress their faces with gauze for 15 to 20 minutes. Control group: The other side of the face(scar site), will receive 0.2mL of normal saline at 2cm interval on the scar site immediately after laser treatment. Participants will be instructed to compress their faces with gauze for 15 to 20 minutes. Intervention group:The intended procedure is to be a pass of ablative fractional co2 laser – a setting of laser power: 25, dot cycle (duration): 3, energy: 30 mj, pixel pitch: 1, and ablation depth: 600 µm -on one side of the face. Control group: The intended procedure is to be, in similar fashion to the intervention group, a pass of ablative fractional co2 laser – a setting of laser power: 25, dot cycle (duration): 3, energy: 30 mj, pixel pitch: 1, and ablation depth: 600 µm- on the other side of the face Atrophic scar of acne. Timepoint: Before and after the intervention. Method of measurement: Photography of scar before beginning ,1 month after first session of treatment and 4 months after second session of treatment. Clinical improvement of scar. Timepoint: 1 month after first session of treatment and 4 months after second session of treatment. Method of measurement: Self-assessment by the patients and visual analogue scale. Treatment associated adverse events(erythema and edema). Timepoint: days 0, 2, 4, 6, 8, 15, and 30 after each session of treatment. Method of measurement: serial photography,inspection by dermatologist and visual analogue scale. Patients satisfaction. Timepoint: 1 month after first session of treatment and 4 months after second session of treatment. Method of measurement: Quartile scale. Isfahan University of Medical Sciences Approved 2014-01-08 Isfahan University of Medical Sciences Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan Isfahan Iran (Islamic Republic of)