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

NCT05626881 | Unknown

• 1 other identifier: Soh-Med-22-04-08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

PRP group

ACTIVE COMPARATOR

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

Silymarin group

ACTIVE COMPARATOR

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

PRP + silymarin group

ACTIVE COMPARATOR

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; Drug: sylimarin cream

Interventions

PRP DRUG

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.

PRP + silymarin group; PRP group

sylimarin cream DRUG

Silymarin was manufactured with concentration of 1.4%

PRP + silymarin group; Silymarin group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females in the reproductive age (18 years old and above) presented with melasma confirmed by wood's light.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 25396123 BACKGROUND

• Cestari TF, Dantas LP, Boza JC. Acquired hyperpigmentations. An Bras Dermatol. 2014 Jan-Feb;89(1):11-25. doi: 10.1590/abd1806-4841.20142353.

  PMID: 24626644 BACKGROUND

• 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.

  PMID: 21965843 BACKGROUND

• 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.

  PMID: 31568636 BACKGROUND

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Walaa k shaker, resident doctor

CONTACT

01064123800; dr_lolo1234@yahoo.com

. Mohammed A ali, assistant professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician at Dermatology department, Sohag University

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 25, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)