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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-12-01

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

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Detailed Description

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Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

PRP

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

sylimarin cream

Intervention Type DRUG

Silymarin was manufactured with concentration of 1.4%

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.

Group Type ACTIVE_COMPARATOR

PRP

Intervention Type 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.

sylimarin cream

Intervention Type DRUG

Silymarin was manufactured with concentration of 1.4%

Interventions

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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.

Intervention Type DRUG

sylimarin cream

Silymarin was manufactured with concentration of 1.4%

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No