Platelet Rich Plasma in Treatment of Melasma

NCT ID: NCT03308370

Last Updated: 2018-06-27

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

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-12-07

Brief Summary

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Melasma is a common acquired disorder characterized by symmetric, hyperpigmented patches with an irregular outline, occurring most commonly on the face. The therapy for melasma has always been challenging and discouraging. Platelet rich plasma has been used over the last several years as an effective treatment in various surgical and medical fields. In recent years, Platelet rich plasma has also started to be used in the field of cosmetology. This study is designed to evaluate the therapeutic effect of platelet rich plasma in melasma.

Detailed Description

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Melasma is a pigmentary disorder that can be disfiguring and can cause to significant emotional stresses for sufferers, for which a universally effective treatment is still lacking. Platelet rich plasma is commonly used in dermatology and plastic surgery, especially for treating chronic wounds, ulcers, and burns. The most important contents of platelets are contained in the α-granules. Some of the bioactive substances present in the α-granules include platelet-derived growth factor, transforming growth factor -β1 and -β2epidermal growth factor, and mitogenic growth factors such as platelet-derived angiogenesis factor and fibrinogen.

transforming growth factor -β1 decreases melanogenesis via delayed extracellular signal-regulated kinase activation. The regression of melasma in a 27-years-old woman after injecting platelet rich plasma for skin rejuvenation was observed, but controlled clinical trials are still lacking to confirm this preliminary observation.

Conditions

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Melasma Platelet Rich Plasma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Platelet rich plasma

intradermal injection of 5 ml of autologous platelet rich plasma in the lesional skin of the face of 20 melasma patients every 4 weeks for 3 times

Group Type EXPERIMENTAL

Platelet rich plasma

Intervention Type BIOLOGICAL

10 ml of blood will be drawn from the patients on an anticoagulant then it will be centrifuged to get platelet rich plasma that will be injected in the melasma lesions of the patients after its activation with calcium chloride.

Interventions

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Platelet rich plasma

10 ml of blood will be drawn from the patients on an anticoagulant then it will be centrifuged to get platelet rich plasma that will be injected in the melasma lesions of the patients after its activation with calcium chloride.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* patients with melasma 18 years old or more

Exclusion Criteria

* Patients less than 18 years.
* Pregnant females and females on oral contraceptive pills.
* Patients with a history of hypertrophic scars or keloids.
* Patients with recurrent herpes infection or with present cutaneous infection and those with facial cancer.
* Patients with blood disorders and platelet abnormalities and chronic liver disease.
* Patients using systemic chemotherapy, anticoagulation therapy and antiplatelet agents.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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A Ghazally

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa H Ghazally, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut university hospitals

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman R Hofny, PHD

Role: CONTACT

01005298992

Amira A Abdel Motaleb, PHD

Role: CONTACT

01005263721

Facility Contacts

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Alaa H Ghazally, M.S.

Role: primary

01007224787

References

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Grimes PE. Melasma. Etiologic and therapeutic considerations. Arch Dermatol. 1995 Dec;131(12):1453-7. doi: 10.1001/archderm.131.12.1453.

Reference Type BACKGROUND
PMID: 7492140 (View on PubMed)

Cayirli M, Caliskan E, Acikgoz G, Erbil AH, Erturk G. Regression of melasma with platelet-rich plasma treatment. Ann Dermatol. 2014 Jun;26(3):401-2. doi: 10.5021/ad.2014.26.3.401. Epub 2014 Jun 12. No abstract available.

Reference Type BACKGROUND
PMID: 24966645 (View on PubMed)

Kim DS, Park SH, Park KC. Transforming growth factor-beta1 decreases melanin synthesis via delayed extracellular signal-regulated kinase activation. Int J Biochem Cell Biol. 2004 Aug;36(8):1482-91. doi: 10.1016/j.biocel.2003.10.023.

Reference Type BACKGROUND
PMID: 15147727 (View on PubMed)

Other Identifiers

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ETEPRPM

Identifier Type: -

Identifier Source: org_study_id

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