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Platelet Rich Plasma in Treatment of Melasma

Primary Purpose

Melasma, Platelet Rich Plasma

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Platelet rich plasma
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

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

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.

Sites / Locations

  • Assiut university hospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Platelet rich plasma

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

evaluation of transforming growth factor beta expression in the melasma skin
compare the intensity of immunohistochemical expression of transforming growth factor beta in skin biopsies taken from the the lesional melasma skin ( of participants who accept only) before and after treatment with platelet rich plasma The results will be scored as follows: 0 for negative staining, 1+ for weak staining, 2+ for moderate staining intensity, and 3+ for strong positive staining.

Full Information

First Posted
October 7, 2017
Last Updated
June 25, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03308370
Brief Title
Platelet Rich Plasma in Treatment of Melasma
Official Title
Evaluation of the Therapeutic Effect of Platelet Rich Plasma in Melasma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 7, 2019 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma, Platelet Rich Plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platelet rich plasma
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Platelet rich plasma
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical improvement of melasma
Description
evaluation of the degree of clinical improvement of melasma by using platelet rich plasma
Time Frame
3 months
Secondary Outcome Measure Information:
Title
evaluation of transforming growth factor beta expression in the melasma skin
Description
compare the intensity of immunohistochemical expression of transforming growth factor beta in skin biopsies taken from the the lesional melasma skin ( of participants who accept only) before and after treatment with platelet rich plasma The results will be scored as follows: 0 for negative staining, 1+ for weak staining, 2+ for moderate staining intensity, and 3+ for strong positive staining.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman R Hofny, PHD
Phone
01005298992
Email
e_riad@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amira A Abdel Motaleb, PHD
Phone
01005263721
Email
amiraali21@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa H Ghazally, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa H Ghazally, M.S.
Phone
01007224787
Email
alaaghazally@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
7492140
Citation
Grimes PE. Melasma. Etiologic and therapeutic considerations. Arch Dermatol. 1995 Dec;131(12):1453-7. doi: 10.1001/archderm.131.12.1453.
Results Reference
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PubMed Identifier
24966645
Citation
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.
Results Reference
background
PubMed Identifier
15147727
Citation
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.
Results Reference
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Platelet Rich Plasma in Treatment of Melasma

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