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

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

Study Overview

• Status: Recruiting
• Conditions: Melasma
• Intervention / Treatment: Drug: PRP; Drug: sylimarin cream

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Walaa k shaker, resident doctor; Phone Number: 01064123800; Email: dr_lolo1234@yahoo.com
• Study Contact Backup: Name: . Mohammed A ali, assistant professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRP group; 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; 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.
Active Comparator: Silymarin group; 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; Silymarin was manufactured with concentration of 1.4%
Active Comparator: PRP + silymarin group; 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; 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%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Sarkar R, Arora P, Garg VK, Sonthalia S, Gokhale N. Melasma update. Indian Dermatol Online J. 2014 Oct;5(4):426-35. doi: 10.4103/2229-5178.142484.
• Cestari TF, Dantas LP, Boza JC. Acquired hyperpigmentations. An Bras Dermatol. 2014 Jan-Feb;89(1):11-25. doi: 10.1590/abd1806-4841.20142353.
• Achar A, Rathi SK. Melasma: a clinico-epidemiological study of 312 cases. Indian J Dermatol. 2011 Jul;56(4):380-2. doi: 10.4103/0019-5154.84722.
• Sirithanabadeekul P, Dannarongchai A, Suwanchinda A. Platelet-rich plasma treatment for melasma: A pilot study. J Cosmet Dermatol. 2020 Jun;19(6):1321-1327. doi: 10.1111/jocd.13157. Epub 2019 Sep 30.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: Soh-Med-22-04-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No