Platelet Rich Plasma in Treatment of Melasma

Melasma Clinical Trial

Official title:

Evaluation of the Therapeutic Effect of Platelet Rich Plasma in Melasma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03308370
• Other study ID #: ETEPRPM
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2017
• Est. completion date: December 7, 2019

Study information

• Verified date: June 2018
• Source: Assiut University
• Contact: Eman R Hofny, PHD
• Phone: 01005298992
• Email: e_riad[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 7, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanosis
• Melasma
• Platelet Rich Plasma

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Cayirli M, Caliskan E, Açikgöz G, Erbil AH, Ertürk 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. — View Citation

Grimes PE. Melasma. Etiologic and therapeutic considerations. Arch Dermatol. 1995 Dec;131(12):1453-7. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical improvement of melasma	evaluation of the degree of clinical improvement of melasma by using platelet rich plasma	3 months
Secondary	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.	3 months