Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- change of acne lasions
研究概览
简要总结
Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and various degrees of scarring.
Platelet-rich plasma (PRP) is prepared by simple centrifugation of whole blood to concentrate platelets and simultaneously remove red blood cells. The resultant supernatant is the PRP that contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF).These growth factors are involved in the healing of soft tissue and can regulate cellular processes such as chemotaxis, angiogenesis, mitogenesis, differentiation, and metabolism .
Topical retinoids are used in the treatment of both noninflammatory and inflammatory acne.Food and Drug Administration (FDA) approved three topical retinoids: adapalene, tazarotene, and tretinoin. These agents help normalize follicular keratinization and decrease keratinocyte cohesiveness, thereby reducing follicular occlusion and comedon formation .Topical retinoids also compete with factors involved in the acne inflammation response, enhance penetration of other topical acne medications, and accelerate the resolution of acne-induced post-inflammatory hyperpigmentation.
Updates from the Global Alliance on Improving Outcomes in Acne consider topical retinoids as first-line therapy, individually or in combination with benzoyl peroxide. However, the common side effects of skin irritation and discomfort may impede adherence to long-term therapy.
For patients with acne, combination therapy with a topical retinoid and platelet-rich plasma (PRP) has not yet been tested.
PRP with topical retinoids will be evaluated and campared with topical retinoids alone in acne tretment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with facial acne vulgaris
- •Age from 12 to 35 years old
排除标准
- •Pregnant or lactating women.
- •patients with history of coagulation disorders.
- •chronic diseases (chronic renal failure, hepatic insufficiency, cardiovascular disorders, uncontrolled diabetes mellitus, thyroid disorders, anemia, autoimmune diseases).
- •patients with unrealistic expectations.
- •Patients received any systemic treatment in the last 6 months.
研究组 & 干预措施
topical retinoid and platelet-rich plasma (PRP) group
干预措施: topical retinoids and platalet rich plasma (Other)
topical retinoid group
干预措施: topical retinoids and platalet rich plasma (Other)
结局指标
主要结局
change of acne lasions
时间窗: after 1 month of treatment completion
record percentage of improvement for each patient after completion of the treatment by comparing before and after digital photographs according to quartile grading scale
次要结局
未报告次要终点
研究者
Howida Omar Twisy
principal investigator
Assiut University