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临床试验/CTRI/2025/08/092877
CTRI/2025/08/092877招募中3 期

A Split face comparative interventional study on efficacy and safety of Microneedling with Human Placenta Extract Formulation vs Microneedling with Autologous Platelet Rich Plasma in treatment of Post Acne Scars

Jawaharlal Nehru Medical College1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
36
试验地点
1
主要终点
Primary Objective:

研究概览

简要总结

Acne scarring remains a therapeutic challenge that frequently necessitates multimodal approaches to achieve optimal outcomes. Microneedling devices offer greater precision, adjustable control of penetration depth, and enhanced efficacy compared to conventional dermarollers, making it a preferred modality for scar revision and collagen remodeling.

While platelet-rich plasma (PRP) is a well-established adjuvant in the management of acne scars, the therapeutic application of Human placenta extract formulation, an aqueous extract of human placenta, remains relatively underexplored. Human placenta extract formulation possesses anti-inflammatory, angiogenic, and fibroblast-inductive properties, promoting collagen synthesis and facilitating tissue repair. However, comparative studies evaluating its efficacy in relation to PRP for scar remodeling in acne are limited.

The present study is designed to compare the efficacy of microneedling combined with Human placenta extract formulation versus microneedling combined with Autologous PRP using a split-face model of intervention. The objective is to assess and compare the effects of both interventions on collagen regeneration, scar texture, and skin quality and assess and compare the safety profile of both treatment modalities . By undertaking this comparative evaluation, the study aims to contribute to the existing knowledge regarding regenerative treatment options for acne scarring.

Lacunae in literature

Due to Heterogeneous Treatment Approaches Despite numerous available modalities for the treatment of acne scars including lasers, subcision, microneedling, PRP, and topical agents—the current literature lacks uniformity. Comparative studies with standardized protocols are scarce, and outcome measures vary widely. This inconsistency, compounded by limited long-term follow-up data, restricts the formulation of comprehensive, evidence-based clinical guidelines.

Limited Comparative Evidence Between PRP and Human Placenta Extract Formulation Platelet-rich plasma (PRP) has been widely studied and accepted as an effective adjunct to microneedling. However, the clinical potential of human placenta extract formulation, a biologically active compound rich in growth factors, cytokines, and regenerative proteins remains largely underexplored in dermatologic applications. Notably, comparative studies exist evaluating the efficacy of human placenta extract formulation and PRP in the treatment of atrophic acne scars. This represents a significant gap in the literature and a critical opportunity for comparative clinical evaluation.

Scarcity of Data on Dermatologic Use of Placenta-Based Therapies Most published studies involving human placenta extract focus on oral mucosal healing (e.g., oral submucous fibrosis, gingival wounds) or chronic non-healing ulcers.Its direct application in dermatologic scar treatment, specifically for acne scars has not been systematically evaluated, leaving a significant gap in clinical understanding.

Neglect of Cost-Effectiveness and Accessibility

While Platelet-Rich Plasma (PRP) therapy has demonstrated clinical efficacy, its dependency on invasive blood collection, variable centrifugation protocols, and stringent sterile preparation limits its feasibility in resource-constrained and outpatient settings. Furthermore, the cost associated with PRP is substantially higher than that of Placentrex. Despite these limitations, there is a notable paucity of studies evaluating more accessible and cost-effective alternatives such as topically applied human placenta extract formulations that may offer comparable therapeutic outcomes.

Inconsistent Evaluation Metrics and Lack of Standardization

The current body of literature is hindered by significant variability in outcome assessment methodologies. Different studies employ diverse scar grading systems—including the Goodman and Baron Scale, ECCA, ASAS, and Visual Analog Scale (VAS) making cross-study comparisons challenging. Furthermore, patient-reported outcomes, such as quality of life indices and subjective satisfaction scores, are often inconsistently documented or entirely absent. This lack of uniformity limits both the clinical relevance and generalizability of findings, underscoring the need for standardized and comprehensive assessment frameworks in future research.

Small Sample Sizes and Limited Statistical Power A significant proportion of available studies are pilot investigations or small split-face trials involving fewer than 30 participants. Such small-scale designs limit statistical power, increase the risk of type II error, and restrict the generalizability of findings to broader patient populations.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 18 to 45 years Fitzpatrick Skin Types III to V Grade II to IV atrophic acne scars based on standard grading Willingness to participate and sign informed consent form.

排除标准

  • Active Acne Presence of inflamed comedones, pustules, or nodulocystic lesions Keloidal or Hypertrophic Scar Tendency History of abnormal scarring or collagen overproduction Hematologic Risk Known coagulopathies or ongoing anticoagulant medication Dermatologic Infections Presence of localized cutaneous viral infections (eg: warts) or localized bacterial infections (eg: folliculitis) Pregnancy or Lactation Pregnant or breastfeeding women Known Allergies Hypersensitivity to human placental extract (formulation) or blood products.

结局指标

主要结局

Primary Objective:

时间窗: 1 YEAR

To evaluate the clinical efficacy of microneedling combined with Human placenta extract formulation in comparison with microneedling combined with Autologous Platelet-Rich Plasma in the treatment of atrophic acne scars by implementing a split-face interventional study design.

时间窗: 1 YEAR

次要结局

  • Secondary Objective:(To compare the safety profile of both treatment modalities by monitoring adverse events, patient tolerance and side effects observed during the course of therapy.)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Mithani Zeal Niraj

Jawaharlal Nehru Medical College

研究点 (1)

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