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

Not Applicable

• Conditions: Melasma; Lasers; Hyperpigmentation; PRP

• Registration Number: NCT04765930
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-04
• Primary Completion: 2021-02-15
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Study First Posted: 2021-02-23
• Last Update Posted: 2021-02-23
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemi-Melasma Area and Severity Index (MASI) score	2 months after final treatment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Dermatology, Cairo University; 🇪🇬 Cairo, Egypt