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IRCT20210811052139N1 IRCT 2021-10-29 PNS shifa karachi efficacy of PRP versus topical 5% minoxidil spray in treatmemt of pattern baldness efficacy of platelet rich plasma versus5% topical minoxidil for the treatment of androgenetic alopecia 2021-11-01 anticipated 35 Complete https://irct.ir/trial/58241 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomized by lottery method (each patient presenting to dermatology out patient department for androgenetic alopecia will be assigned a number and will be selected randomly so each patient has same probability to be included in the study), Blinding description: response to treatment will be assessed as follows Patient hair should be dry and clean. He will be advised to maintain the same hair style and hair colour on each visit. Appropriate lightening will be used; multiple images will be shot at vertex and mid pattern. For vertex view patient will be asked to look at the ceiling. For mid pattern patient will be instructed to place hand flat on table with fingers of both hands interlocked, and now place his/her face on hand . Results will be interpreted by investigator 7 point score [14]. - 3 = greatly decreased -2 = moderately decreased -1 = slightly decreased 0 = no change 1 = slightly increased 2 = moderately increased 3 = greatly increase photograph will be taken at 0 ,3 , and 6 months one dermatologist will be blinded to the treatment group of the patient. 3 Androgenetic Alopecia. Intervention 1: Intervention group 1: After all aseptic measures 30 ml of venous blood will be drawn into a tube containing citrate phosphate dextrose (prevent platelet activation and degranulation), blood then subjected to two spins, a soft spin at 2500 rpm for 10 minutes and a hard spin at 3500 rpm for 15 minutes, the soft spin will separate blood in 3 layers lowermost layer is of RBC (Red blood cells), the uppermost layer is PPP (platelet-poor plasma) and the middle layer is PRP (platelet-rich plasma). In another tube PPP, PRP and a few RBC without anticoagulant will undergo hard spin. In this way, PRP will be settled at the bottom and PPP at the uppermost layer. PPP will be discarded and the remaining PRP will be used for the procedure. For procedure, this PRP will be collected in a sterile insulin syringe containing calcium gluconate which acts as an activator for platelets. Calcium gluconate to PRP ratio used will be 1:9. Now, this activated and highly concentrated PRP will be injected intradermally, in a dose of 0.1 -0.2 ml per injection 1 cm apart in interfollicular regions. A total of 6 sessions will be done, each session 1 month apart. Intervention 2: Intervention group2: . Participants of group B will be advised to apply topical 5% minoxidil 1 ml over dry scalp 12 hourly. Participants of both groups will be assessed on 0, 3, and 6 months. The serial photographs will be taken at each assessment. The Final outcome i.e. efficacy (as mention above) will be measured after 6 months of starting treatment. Confounding variables and bias will be controlled by strictly following inclusion and exclusion criteria. 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 further information
public Ghazal afzal
PNS shifa karachi
karachi Pakistan 07011 +92 21 48506482 ghazalafzal@outlook.com PNS shifa karachi scientific Ghazal afzal
PNS SHIFA KARACHI
karachi Pakistan 07011 +92 21 48506482 ghazalafzal@outlook.com PNS shifa karachi Pakistan Age 18 to 60 years patient has not taken any kind of medical treatment for hair loss or has not used treatment for more than 6 months duration duration of AGA >6months Patient Hamilton-Norwood grade ≥2 and ≤ 5 or Ludwig scale grade 1-2. Platelets count more than150, 000 /µl 18 years 60 years Both  Patients with alopecia other than AGA, such as telogen effluvium, alopecia areata, acquired cicatricial alopecia, or anagen effluvium. The patient on warfarin or heparin the infective disease of scalp patoents who has taken any treatment for AGA history of thyroid disorder patient with hypersensitivity to minoxidil in past any infective skin disease pregnancy/lactation patient takinh aspirin unrealistic expectation L64.9 Androgenic alopecia, unspecified Treatment - Drugs Treatment - Drugs Intervention group 1: After all aseptic measures 30 ml of venous blood will be drawn into a tube containing citrate phosphate dextrose (prevent platelet activation and degranulation), blood then subjected to two spins, a soft spin at 2500 rpm for 10 minutes and a hard spin at 3500 rpm for 15 minutes, the soft spin will separate blood in 3 layers lowermost layer is of RBC (Red blood cells), the uppermost layer is PPP (platelet-poor plasma) and the middle layer is PRP (platelet-rich plasma). In another tube PPP, PRP and a few RBC without anticoagulant will undergo hard spin. In this way, PRP will be settled at the bottom and PPP at the uppermost layer. PPP will be discarded and the remaining PRP will be used for the procedure. For procedure, this PRP will be collected in a sterile insulin syringe containing calcium gluconate which acts as an activator for platelets. Calcium gluconate to PRP ratio used will be 1:9. Now, this activated and highly concentrated PRP will be injected intradermally, in a dose of 0.1 -0.2 ml per injection 1 cm apart in interfollicular regions. A total of 6 sessions will be done, each session 1 month apart Intervention group2: . Participants of group B will be advised to apply topical 5% minoxidil 1 ml over dry scalp 12 hourly. Participants of both groups will be assessed on 0, 3, and 6 months. The serial photographs will be taken at each assessment. The Final outcome i.e. efficacy (as mention above) will be measured after 6 months of starting treatment. Confounding variables and bias will be controlled by strictly following inclusion and exclusion criteria. Photographic evaluation. Timepoint: at 0, 3, and 6 months. Method of measurement: photographic evaluation,patient satisfaction score ,investigator 7 point score,Patient standardized hair growth questionnaire. Patient satisfaction score. Timepoint: 6 month. Method of measurement: this is measured by using standarize patient satisfaction score,0: no improvement 1: 1%–25% improvement 2: 25%–50% improvement 3: 50%–75% improvement 4: 76%–100% improvement. Investigator 7 point score,. Timepoint: 0 and 6 month, - 3 = greatly decreased -2 = moderately decreased-1 = slightly decreased0 = no change 1 = slightly increased 2 = moderately increased3 = greatly increased. Method of measurement: using serial photograph taken at 0,3 and 6 months,improvement in hair density will be noted. Patient standardized hair growth questionnaire. Timepoint: 6 month. Method of measurement: with answer of questions regarding hair loss. PNS shifa karachi Approved 2021-09-14 Hospital Ethical and Research Committee PNS shifa karachi Main Korangi Rd, near Kala Pul، Clifton, Karachi, Karachi City, Sindh PNS Shifa Hospital, address karachi Sindh Pakistan