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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Melasma

Intervention / Treatment
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* Drug: PRP
* Drug: sylimarin cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females in the reproductive age (18 years old and above) presented with melasma confirmed by wood's light. Exclusion Criteria: Pregnant and lactating. Systemic diseases that may cause facial hyperpigmentation (e.g: thyroid diseases, renal, hepatic or endocrinal disorders). Patients receiving depigmenting drugs oral or topical in previous 3 months, drugs that prolong bleeding as aspirin, hormone replacement therapy or contraceptive pills. Patients with anemia, thrombocytopenia, coagulopathies or patient on anticoagulant therapy and patients with iron deficiency. Patient with infections in the face e.g. herpes. Patients with history of scarring or keloid formation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRP group<br>It will include patients with melasma treated with PRP sessions every two weeks for three monthsPRP is injected intralesionally at the site of melasma using a 30 G hypodermic needle through an insulin syringe. A maximum of 2.0 ml of PRP will be injected into the dermis (about 1.5-2.0 mm deep) about 1 cm apart to raise dermal papules | Drug: PRP<br>* 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.<br>|
| Active Comparator: Silymarin group<br>It will include patients with melasma applying with topical Silymarin cream. Silymarin cream will be prepared in the Faculty of Pharmcy according to the following formulation: stearic acid 15 g, glycerin 5 g, KOH 0.72 g, H2O 79 g, sodium benzoate (0.1%), and Tween-80 (1%). Silymarin was manufactured with concentration of 1.4%. Silymarin will be applied twice daily. The duration of treatment will be 3 months. | Drug: sylimarin cream<br>* Silymarin was manufactured with concentration of 1.4%<br>|
| Active Comparator: PRP + silymarin group<br>It will be treated by using both PRP sessions and applying topical Silymarin cream. Silymarin will be applied twice daily, while PRP sessions every 2 weeks. | Drug: PRP<br>* 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.<br>Drug: sylimarin cream<br>* Silymarin was manufactured with concentration of 1.4%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in mMASI SCORE | The mMASI score is calculated by subjective assessment of 3 factors: area (A) of involvement, darkness (D), and homogeneity (H), with the forehead (f), right malar region (rm), left malar region (lm), and chin (c), corresponding to 30%, 30%, 30%, and 10% of the total face, respectively. The area of involvement in each of these 4 areas is given a numeric value of 0 to 6 (0 = no involvement; 1 = \10%; 2 = 10%-29%; 3 = 30%-49%; 4 = 50%-69%; 5 = 70%-89%; and 6 = 90%- 100%). Darkness and homogeneity are rated on a scale from 0 to 4 (0 = absent; 1 = slight; 2 = mild; 3 = marked; and 4 = maximum). The MASI score is calculated by adding the sum of the severity ratings for darkness and homogeneity, multiplied by the value of the area of involvement, for each of the 4 facial areas. The total score range is 0 to 48. | 8 months |