Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma

Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in the Treatment of Melasma: A Split Face Study.

Melasma is a common, acquired, esthetically disfiguring hypermelanosis of the face. Melasma is considered a disappointing challenge when treatment options are addressed. Diverse treatment modalities such as retinoic acid, hypo-pigmenting agents like hydroquinone, azelaic acid, and kojic acid, chemical peels, microdermabrasion, and lasers have been tried for the treatment of melasma. There is no universally proven therapy that induces and maintains remission of the condition. Q-switched: Nd YAG laser toning and platelet rich plasma (PRP) are promising treatments for melasma.The aim of this work is evaluate the efficacy and safety of combined PRP and Q-switched: NdYAG laser in the treatment of melasma using clinical assessment, in addition to assessment of Melanin Index and Erythema Index.

Study Overview

• Status: Recruiting
• Conditions: Hyperpigmentation; Melasma; Lasers; PRP
• Intervention / Treatment: Other: Q-switched nd:YAG laser toning

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mona El-Kalioby, MD; Phone Number: +201224442941; Email: mona.elkalioby@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Department of Dermatology, Cairo University
    • Contact: Mona El-Kalioby, MD; Email: monaelkalioby@cu.edu.eg
    • Principal Investigator: Tahra Leheta, MD
    • Sub-Investigator: Yosra Shawky, MBBCh
    • Sub-Investigator: Mona El-Kalioby, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with bilateral nearly symmetric melasma on the face.

Exclusion Criteria:

• Patients receiving systemic or topical or laser treatment relevant to melasma within three months before enrollment into the study.
• Use of oral or injectable contraceptives or hormone replacement therapy during treatment or 12 months before
• Patients active skin infections and active HSV
• History of hypertrophic scars or keloids.
• Patients with hypercoagulable state or bleeding diatheses
• Pregnant and lactating females.
• History of liver diseases
• Intake of systemic chemotherapy, corticosteroids, antiplatelets or anticoagulants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRP Injection; Half of the face	Other: Q-switched nd:YAG laser toning; Q-switched nd:YAG laser toning for melasma.
Placebo Comparator: Saline injection; Other half of the face	Other: Q-switched nd:YAG laser toning; Q-switched nd:YAG laser toning for melasma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemi-Melasma Area and Severity Index (MASI) score	Hemi-Melasma Area and Severity Index(MASI) score for Pigmentation, and Area of involvement. The minimum value is 0 and the maximum value is 12. Higher scores mean a worse outcome.	2 months after final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melanin Index	Objective assessment of melanin index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome.	2 months after final treatment
Erythema Index	Objective assessment of erythema index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome.	2 months after final treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paients' Satisfaction assessed by the VAS	a four-scale grading score: poor: response rate= 0-25%; fair: response rate= 25-50%; good: response rate=50-75%; excellent: response rate=75-100%	2 months after final treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): February 15, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Melanin Index; laser toning; Hemi-MASI; Colorimeter; Erythema Index
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Melanosis; Hyperpigmentation
• Other Study ID Numbers: MelaPRP2020

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