Efficacy and Safety of Combined Nanofat Injection With Either Platelet Rich Fibrin or Microneedling Versus Nanofat Injection Alone in the Treatment of Facial Atrophic Post Acne Scars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- compare the efficacy and safety of combined nanofat injection with either platelet rich fibrin or microneedling versus nanofat injection alone in the treatment of facial atrophic post acne scars.
研究概览
简要总结
To compare the efficacy and safety of combined nanofat injection with either platelet rich fibrin or microneedling versus nanofat injection alone in the treatment of facial atrophic post acne scars.
详细描述
Inflammatory acne lesions may result in permanent scars . Atrophic, hypertrophic, and keloidal scars are the categories into which acne scars can be generically divided . Atrophic scarring represents about 75% of acne scars and is subdivided into icepick, rolling, and boxcar scars .
Currently, there is no standard treatment for atrophic acne scars. Various treatment approaches have been used to improve the appearance of acne scars, with varying degrees of success ]. Traditional treatment methods include lasers, platelet-rich plasma (PRP), excisions, skin abrasion, chemical peeling, tissue filling, microneedling, thread lifting, and photodynamic therapy, while emerging therapies such as mesenchymal stem cells (MSCs) and their derivatives are also available .
Autologous fat grafting is an alternative modality in managing post acne scarring . In 2013, Tonnard was the first person who described the technique of obtaining nano fat. Its capacity for regeneration is attributable to the adipose tissue-derived stem cells (ADSCs) and stromal vascular fraction (SVF) cells that promote blood vessel formation and the secretion of growth factors that impede fibrosis and inflammation, speed up wound healing, and improve skin texture.
Platelet-rich fibrin (PRF), the second-generation platelet concentrate, was developed for the purpose of removing anticoagulants and for better release of growth factors. A rapid and short centrifugation procedure is needed for separation of blood layers before clotting. A fibrin matrix is formed in the platelet-rich layer entrapping platelets and leukocytes in it. This matrix makes the release of growth factors slow and prolonged comparing with PRP .
Microneedling (MN) therapy has been used as a treatment for various dermatological conditions, including scar tissue . This technique involves repetitive skin puncture using sterile microneedles to disrupt dermal collagen that connects the scar tissue. The needle will penetrate the stratum corneum and generate small holes with minimal damage to the epidermis. This process will provoke the regeneration of growth factors to stimulate collagen and elastin production . To the best of our knowledge, platelet rich fibrin and microneedling have never been tried with nanofat injection in the treatment of atrophic post acne scars and our study is the first to do so.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years of both sexes with moderate to severe atrophic facial acne scars on both cheeks
排除标准
- •1. Patients' age <18 or >45 years
- •Pregnant and lactating women
- •active inflammatory acne or active infection in the treatment area.
- •treatment of the targeted study sites within 2 months
- •history of chronic diseases (autoimmune diseases, bleeding disorders, taking anticoagulant therapy or aspirin)
- •history of hypertrophic scars or keloid formation tendency.
- •patients with unrealistic expectations.
研究组 & 干预措施
nanofat injection and platelet rich fibrin
(21 patients) single nanofat injection on both sides of the face, followed by platelet rich fibrin injection on one side of face monthly for 3 months.
干预措施: nanofat injecion (Procedure)
nanofat injection and platelet rich fibrin
(21 patients) single nanofat injection on both sides of the face, followed by platelet rich fibrin injection on one side of face monthly for 3 months.
干预措施: Platelet rich fibrin (Procedure)
nanofat injection and miconeedling
(21 patients)- single nanofat injection on both sides of the face, followed by microneedling on one side of face monthly for 3 months.
干预措施: nanofat injecion (Procedure)
nanofat injection and miconeedling
(21 patients)- single nanofat injection on both sides of the face, followed by microneedling on one side of face monthly for 3 months.
干预措施: Microneedling (Procedure)
结局指标
主要结局
compare the efficacy and safety of combined nanofat injection with either platelet rich fibrin or microneedling versus nanofat injection alone in the treatment of facial atrophic post acne scars.
时间窗: 6 months
Comaprison among different treatment modalities will be done by 1-Goodman and Baron qualitative score : Goodman and Baron qualitative Scale for each side of the face will be performed for all groups by counting and grading scars at the baseline and 3 months after the last session, then comparing its values before the start of treatment and 3 months after the last session Grade 1 (Macular): Erythematous, hyperpigmented, or hypopigmented flat marks. Grade 2 (Mild): Mild atrophic or hypertrophic scars, usually concealable with makeup or hair. Grade 3 (Moderate): Obvious, noticeable scars that are not easily hidden, sometimes showing "ice-pick" characteristics. Grade 4 (Severe): Marked, deep, or severe scarring, or widespread, severe scarring. Is nanofat injection alone effective in treamtment of post acne scars or when combined with either platelt rich fibrin or microneedling is better?
次要结局
- Patient's satisfaction(6 months)
- Pain assessment(6 months)
- Histopathological evaluation(6 months)
研究者
Marilyn Sameh
Assistant lecturer
Assiut University
