Platelet Rich Plasma in Treatment of Melasma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03308370|
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Melasma Platelet Rich Plasma||Biological: Platelet rich plasma||Phase 3|
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)|
|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|
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.
- clinical improvement of melasma [ Time Frame: 3 months ]evaluation of the degree of clinical improvement of melasma by using platelet rich plasma
- 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.
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
|Contact: Eman R Hofny, PHDfirstname.lastname@example.org|
|Contact: Amira A Abdel Motaleb, PHDemail@example.com|
|Assiut university hospitals||Recruiting|
|Contact: Alaa H Ghazally, M.S. 01007224787 firstname.lastname@example.org|
|Principal Investigator:||Alaa H Ghazally, MD||Assiut University|