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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03308370
Other study ID # ETEPRPM
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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