Platelet Rich Plasma in Treatment of Melasma

NCT03308370 | Unknown Phase 3

• 1 other identifier: ETEPRPM
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melasma; Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• clinical improvement of melasma

  evaluation of the degree of clinical improvement of melasma by using platelet rich plasma

  3 months

Secondary Outcomes (1)

• evaluation of transforming growth factor beta expression in the melasma skin

  3 months

Study Arms (1)

Platelet rich plasma

EXPERIMENTAL

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

Biological: Platelet rich plasma

Interventions

Platelet rich plasma 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.

Platelet rich plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with melasma 18 years old or more

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

RECRUITING

Related Publications (3)

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

  PMID: 7492140 BACKGROUND

• 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.

  PMID: 24966645 BACKGROUND

• 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.

  PMID: 15147727 BACKGROUND

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alaa H Ghazally, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman R Hofny, PHD

CONTACT

01005298992; e_riad@yahoo.com

Amira A Abdel Motaleb, PHD

CONTACT

01005263721; amiraali21@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 7, 2017
• First Posted: October 12, 2017
• Study Start: November 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 7, 2019
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

EG (1)