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

Primary Purpose

Hyperpigmentation, Melasma, PRP

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Q-switched nd:YAG laser toning
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperpigmentation focused on measuring laser toning, Hemi-MASI, Colorimeter, Erythema Index, Melanin Index

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Dermatology, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PRP Injection

Saline injection

Arm Description

Half of the face

Other half of the face

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Melanin Index
Objective assessment of melanin index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome.
Erythema Index
Objective assessment of erythema index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome.

Full Information

First Posted
February 4, 2021
Last Updated
February 18, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04765930
Brief Title
Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 15, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperpigmentation, Melasma, PRP, Lasers
Keywords
laser toning, Hemi-MASI, Colorimeter, Erythema Index, Melanin Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP Injection
Arm Type
Active Comparator
Arm Description
Half of the face
Arm Title
Saline injection
Arm Type
Placebo Comparator
Arm Description
Other half of the face
Intervention Type
Other
Intervention Name(s)
Q-switched nd:YAG laser toning
Intervention Description
Q-switched nd:YAG laser toning for melasma.
Primary Outcome Measure Information:
Title
Hemi-Melasma Area and Severity Index (MASI) score
Description
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.
Time Frame
2 months after final treatment
Secondary Outcome Measure Information:
Title
Melanin Index
Description
Objective assessment of melanin index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome.
Time Frame
2 months after final treatment
Title
Erythema Index
Description
Objective assessment of erythema index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome.
Time Frame
2 months after final treatment
Other Pre-specified Outcome Measures:
Title
Paients' Satisfaction assessed by the VAS
Description
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%
Time Frame
2 months after final treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona El-Kalioby, MD
Phone
+201224442941
Email
mona.elkalioby@kasralainy.edu.eg
Facility Information:
Facility Name
Department of Dermatology, Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona El-Kalioby, MD
Email
monaelkalioby@cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Tahra Leheta, MD
First Name & Middle Initial & Last Name & Degree
Yosra Shawky, MBBCh
First Name & Middle Initial & Last Name & Degree
Mona El-Kalioby, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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