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

Sohag University60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melasma

Interventions

PRPDRUG

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.

sylimarin creamDRUG

Silymarin was manufactured with concentration of 1.4%

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 8 months

Central Contacts

Walaa k shaker, resident doctor

CONTACT

01064123800 dr_lolo1234@yahoo.com

. Mohammed A ali, assistant professor

CONTACT

Data from ClinicalTrials.gov

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