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Platelet Rich Plasma in Treatment of Melasma

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ClinicalTrials.gov Identifier: NCT03308370
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
A Ghazally, Assiut University

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.

Condition or disease Intervention/treatment Phase
Melasma Platelet Rich Plasma Biological: Platelet rich plasma Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Therapeutic Effect of Platelet Rich Plasma in Melasma
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 7, 2019

Arm Intervention/treatment
Experimental: 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
Biological: 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.




Primary Outcome Measures :
  1. clinical improvement of melasma [ Time Frame: 3 months ]
    evaluation of the degree of clinical improvement of melasma by using platelet rich plasma


Secondary Outcome Measures :
  1. evaluation of transforming growth factor beta expression in the melasma skin [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308370


Contacts
Contact: Eman R Hofny, PHD 01005298992 e_riad@yahoo.com
Contact: Amira A Abdel Motaleb, PHD 01005263721 amiraali21@yahoo.com

Locations
Egypt
Assiut university hospitals Recruiting
Assiut, Egypt
Contact: Alaa H Ghazally, M.S.    01007224787    alaaghazally@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Alaa H Ghazally, MD Assiut University

Publications:
Responsible Party: A Ghazally, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03308370     History of Changes
Other Study ID Numbers: ETEPRPM
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases