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

NCT ID: NCT04765930

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-03-01

Brief Summary

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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

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Conditions

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Hyperpigmentation Melasma PRP Lasers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PRP Injection

Half of the face

Group Type ACTIVE_COMPARATOR

Q-switched nd:YAG laser toning

Intervention Type OTHER

Q-switched nd:YAG laser toning for melasma.

Saline injection

Other half of the face

Group Type PLACEBO_COMPARATOR

Q-switched nd:YAG laser toning

Intervention Type OTHER

Q-switched nd:YAG laser toning for melasma.

Interventions

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Q-switched nd:YAG laser toning

Q-switched nd:YAG laser toning for melasma.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mona El-Kalioby

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Dermatology, Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mona El-Kalioby, MD

Role: CONTACT

+201224442941

Facility Contacts

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Mona El-Kalioby, MD

Role: primary

Other Identifiers

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MelaPRP2020

Identifier Type: -

Identifier Source: org_study_id

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