Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFebruary 23, 2021
February 1, 2021
1.4 years
February 4, 2021
February 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Melanin Index
2 months after final treatment
Erythema Index
2 months after final treatment
Other Outcomes (1)
Paients' Satisfaction assessed by the VAS
2 months after final treatment
Study Arms (2)
PRP Injection
ACTIVE COMPARATORHalf of the face
Saline injection
PLACEBO COMPARATOROther half of the face
Interventions
Q-switched nd:YAG laser toning for melasma.
Eligibility Criteria
You may qualify if:
- Patients with bilateral nearly symmetric melasma on the face.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Department of Dermatology, Cairo University
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 4, 2021
First Posted
February 23, 2021
Study Start
October 1, 2019
Primary Completion
February 15, 2021
Study Completion
March 1, 2021
Last Updated
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share