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IRCT20230816059168N1 IRCT 2023-08-28 Self Bio filler Vs Platelet rich plasma mesotherapy in the treatment of Peri-orbital hyperpigmentation Biofiller Vs Platelet rich plasma mesotherapy in the treatment of Peri-orbital hyperpigmentation in patients presenting to outpatient department of dermatology in a tertiary care hospital-An RCT 2023-09-01 anticipated 42 Complete https://irct.ir/trial/72136 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple, Non-probability randomized sampling in patients divided into two random groups by use of lottery method in individuals by giving the patients sealed envelopes of 2 types to choose one blindly from one of them.And afterwards divided into two groups, Blinding description: Patients fulfilling the inclusion criteria and excluding the exclusion criteria will be randomly divided into two groups by lottery method. Half of them will be treated by bio fillers and another half by PRP mesotherapy. They will not be knowing, which treatment they are undergoing. After 01 month of completion of treatment another dermatologist will blindly assess the results. He/she will not be knowing which treatment the patient underwent, as both are injected by injection and cannulas peri-orbitally. 3 Peri orbital hyperpigmentation. Intervention 1: Intervention group 1: Topical eutectic mixture of local anesthetic cream will be applied over the patient’s face around eyes for 45 min. Ten milliliters of patient’s blood will be drawn and mixed with 1 mL anticoagulant acid citrate dextrose. It will be rotated at 3500 rotations per minute (RPM) for 15 min and then centrifuged again at 1500 RPM for 5 min. The upper part that is platelet-poor plasma (PPP) will be withdrawn in a 5 mL syringe, approximately 4.5 cc. PPP will be incubated in hot water at 100°C for 5 min and then cooled in a refrigerator for 5 min. The viscous gel, approximately 3 to 4 ml in volume, will be ready for use. After cleaning of the topical anesthetic cream, PPP gel filler will be injected below the dermis just above the bone with 27G cannula in a linear threading technique. The sites were gently massaged to allow uniform distribution of the injected plasma gel to maintain the contour of the surrounding tissues. Patient will be advised to avoid NSAIDS for 5-7 days’ post procedure. This procedure will be repeated 2 times in a monthly interval. Intervention 2: Intervention group 2: Topical eutectic mixture of local anesthetic cream will be applied over the patient’s face around eyes for 45 min. Ten milliliters of patient’s blood will be drawn and mixed with 1 mL anticoagulant acid citrate dextrose. It will be rotated at 3500 rotations per minute (RPM) for 15 min and then centrifuged again at 1500 RPM for 5 min. The lower part that is PRP was withdrawn in 3 insulin (1 mL) syringes, approximately 2.5 ml. It will be injected by meso- therapy around 2 ml around each eye avoiding blood vessels and, hence bruising. Patient will be advised to avoid NSAIDS for 5-7 days’ post procedure. This procedure will be repeated 2 times in a monthly interval. Yes - There is a plan to make this available What will be shared: Biofiller Vs Platelet rich plasma mesotherapy in the treatment of Peri-orbital hyperpigmentation When: after the study will be published To whom: open access Conditions: will be available on research gate Where to obtain: Research gate after publication How to obtain: E-mail Comments:
public Dr.Sakina Sadiq Malik
Saddar,Rawalpindi
Rawalpindi Pakistan 44000 +92 321 5108737 dazzlingdocsak2078@hotmail.com AM college Rwp scientific Dr.Sakina Sadiq Malik
Saddar,Rawalpindi
Rawalpindi Pakistan 44000 +92 321 5108737 dazzlingdocsak2078@hotmail.com AM college Rwp Pakistan All patients with peri-orbital hyperpigmentation willing to participate in our study. Patients with peri-orbital hyperpigmentation, aged 18-65 years. Patients of Fitzpatrick skin type 1-4. 18 years 65 years Both Patients having Hep B or C or HIV (as PRP and bio fillers are blood products and dealing with infected people can be hazardous for treating staff). Patients on immunosuppressant medications due to other diseases Pregnant women. Patients on anti-platelet or anticoagulants or fibrinolytics Patients using or have used other treatments for dark circles Patients of Fitzpatrick skin type 5 or 6 L81.4 Other melanin hyperpigmentation Treatment - Other Treatment - Other Intervention group 1: Topical eutectic mixture of local anesthetic cream will be applied over the patient’s face around eyes for 45 min. Ten milliliters of patient’s blood will be drawn and mixed with 1 mL anticoagulant acid citrate dextrose. It will be rotated at 3500 rotations per minute (RPM) for 15 min and then centrifuged again at 1500 RPM for 5 min. The upper part that is platelet-poor plasma (PPP) will be withdrawn in a 5 mL syringe, approximately 4.5 cc. PPP will be incubated in hot water at 100°C for 5 min and then cooled in a refrigerator for 5 min. The viscous gel, approximately 3 to 4 ml in volume, will be ready for use. After cleaning of the topical anesthetic cream, PPP gel filler will be injected below the dermis just above the bone with 27G cannula in a linear threading technique. The sites were gently massaged to allow uniform distribution of the injected plasma gel to maintain the contour of the surrounding tissues. Patient will be advised to avoid NSAIDS for 5-7 days’ post procedure. This procedure will be repeated 2 times in a monthly interval. Intervention group 2: Topical eutectic mixture of local anesthetic cream will be applied over the patient’s face around eyes for 45 min. Ten milliliters of patient’s blood will be drawn and mixed with 1 mL anticoagulant acid citrate dextrose. It will be rotated at 3500 rotations per minute (RPM) for 15 min and then centrifuged again at 1500 RPM for 5 min. The lower part that is PRP was withdrawn in 3 insulin (1 mL) syringes, approximately 2.5 ml. It will be injected by meso- therapy around 2 ml around each eye avoiding blood vessels and, hence bruising. Patient will be advised to avoid NSAIDS for 5-7 days’ post procedure. This procedure will be repeated 2 times in a monthly interval. Photographs will be taken at the start of treatment and then 01 months after the last treatment. A validated photo-numeric scale for infraorbital dark circles proposed by M.M. O’Mahony et al, will be used in our study as objective measurement of periorbital dark circles intensity before and after treatment. Timepoint: 01 month after the last treatment. Method of measurement: Photo-numeric scale. Self Approved 2023-08-10 Ethical commitee Pak Emirates Military Hospital Saddar,Rawalpindi Rawalpindi Punjab Pakistan