Clinical trial NCT03308370: Platelet Rich Plasma in Treatment of Melasma
Official title: Evaluation of the Therapeutic Effect of Platelet Rich Plasma in Melasma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Melasma
Platelet Rich Plasma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: clinical improvement of melasma
timeFrame: 3 months
Secondary outcomes:
measure: evaluation of transforming growth factor beta expression in the melasma skin
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
affiliation: Assiut University
name: Alaa H Ghazally, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grimes PE. Melasma. Etiologic and therapeutic considerations. Arch Dermatol. 1995 Dec;131(12):1453-7. doi: 10.1001/archderm.131.12.1453.
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.
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.