NCT05626881

Efficacy of Intralesional PRP +/- Topical Silymarin in the Treatment of Melasma

Evaluation of the Efficacy and Tolerability of Autologous Intralesional Platelet-rich Plasma, Topical Silymarin, and Combined Autologous Intralesional Platelet-rich Plasma With Topical Silymarin in the Treatment of Melasma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Melasma is an acquired disorder of melanogenesis leading to hyperpigmentation and manifested by symmetrical brown to gray-black macules and patches with serrated irregular edges . It occurs especially in sun-exposed areas and affects young to middle-aged women. It is most commonly seen on the face and less commonly on the neck, arms, and chest . Platelet rich plasma (PRP) is defined as a small volume of autologous plasma that contains a high concentration of platelets obtained by centrifugation of autologous blood and subsequent suspension of platelets

Conditions

• Melasma

Interventions

Type	Name	Description
DRUG	PRP	It will include patients with melasma treated with PRP sessions every two weeks for three months. 10 ml of venous blood will withdraw by means of a wide bore needle and a vacutainer containing an anticoagulant (Acid citrate dextrose). Double centrifugation will be done. First centrifugation, will be done for 10 minutes. After the first centrifugation, three layers will be seen , Second centrifugation will be done for 10 min, after which the platelets separate and form a grayish pellet at the bottom of the tube and the rest will be platelet-poor plasma. About 1 ml of this platelet-poor plasma will be decanted off and the platelet pellet will be resuspended in the remaining plasma to get PRP. With 10 ml blood, about 1-1.5 ml of PRP will be obtained. PRP is injected intralesionally at the site of melasma using a 30 G hypodermic needle through an insulin syringe.
DRUG	sylimarin cream	Silymarin was manufactured with concentration of 1.4%

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2022-11-25
• Last updated: 2022-11-25

Locations

1 site across 1 country: Egypt