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

Melasma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04765930
• Other study ID #: MelaPRP2020
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: Mona El-Kalioby, MD
• Phone: +201224442941
• Email: mona.elkalioby[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperpigmentation
• Lasers
• Melanosis
• Melasma
• PRP

Intervention

Other:
• Q-switched nd:YAG laser toning
Q-switched nd:YAG laser toning for melasma.

Locations

Country	Name	City	State
Egypt	Department of Dermatology, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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