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CTRI Number  CTRI/2025/08/092877 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A split face study comparing microneedling with human placenta extract and microneedling with platelet-rich plasma (PRP)for the treatment of acne scars  
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mithani Zeal Niraj 
Designation  Junior Resident , Department of Dermatology, Venereology and Leprology 
Affiliation  Jawaharlal Nehru Medical College 
Address  Junior Resident, Department of Dermatology, Venereology and Leprology, Jawaharlal Nehru Medical College Belagavi - 590010 Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  09769050740  
Fax    
Email  zealnmithani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhavana R Doshi  
Designation  HOD, Department of Dermatology, Venereology and Leprology 
Affiliation  Jawaharlal Nehru Medical College 
Address  HOD, Department of Dermatology, Venereology and Leprology Jawaharlal Nehru Medical College Belagavi – 590010 Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9422306523  
Fax    
Email  bhavs1982@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhavana R Doshi  
Designation  HOD, Department of Dermatology, Venereology and Leprology  
Affiliation  Jawaharlal Nehru Medical College 
Address  HOD, Department of Dermatology, Venereology and Leprology Jawaharlal Nehru Medical College Belagavi – 590010 Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9422306523  
Fax    
Email  bhavs1982@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Jawaharlal Nehru Medical College 
Address  Belagavi – 590010 Karnataka  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Zeal Mithani  KLEs DR Prabhakar Kore Hospital and Medical Research Center (MRC)  Dermatology OPD No 23 , Consultation room no 1 and 2 G+1 Krishna Floor , KLEs Dr Prabhakar Kore Hospital Nehru Nagar , Belagavi
Belgaum
KARNATAKA 
09769050740

zealnmithani@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee, JNMC Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L708||Other acne,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  HUMAN PLACENTAL EXTRACT FORMULATION  The study protocol is designed to allow direct intra-individual comparison between two modalities for treating atrophic acne scars using a split-face interventional model. Each subject’s face will be bisected along the midline in the sagittal plane to create a split-face model. Although randomization is not performed in this split-face design, the CONSORT structure ensures methodological transparency and adherence to ethical and clinical trial reporting standards. Screening and Enrollment Phase: Participants will be enrolled continuously as they present to the outpatient department. Intervention Phase (Microneedling + Topical application of Human placenta extract formulation / PRP sessions): (Session 1 at Week 0, Session 2 at Week 4, and Session 3 at Week 8) Follow-up and Final Assessment Phase: (Final evaluation at Week 12) following the third intervention session.  
Comparator Agent  PLATELET RICH PLASMA  The study protocol is designed to allow direct intra-individual comparison between two modalities for treating atrophic acne scars using a split-face interventional model. Each subject’s face will be bisected along the midline in the sagittal plane to create a split-face model. Although randomization is not performed in this split-face design, the CONSORT structure ensures methodological transparency and adherence to ethical and clinical trial reporting standards. Screening and Enrollment Phase: Participants will be enrolled continuously as they present to the outpatient department. Intervention Phase (Microneedling + Topical application of Human placenta extract formulation / PRP sessions): (Session 1 at Week 0, Session 2 at Week 4, and Session 3 at Week 8) Follow-up and Final Assessment Phase: (Final evaluation at Week 12) following the third intervention session.  
Intervention  SPLIT FACE COMPARATIVE INTERVENTION ON HUMAN PLACENTAL EXTRACT FORMULATION VS PLATELET RICH PLASMA   The study protocol is designed to allow direct intra-individual comparison between two modalities for treating atrophic acne scars using a split-face interventional model. Each subject’s face will be bisected along the midline in the sagittal plane to create a split-face model. Although randomization is not performed in this split-face design, the CONSORT structure ensures methodological transparency and adherence to ethical and clinical trial reporting standards. Screening and Enrollment Phase: Participants will be enrolled continuously as they present to the outpatient department. Intervention Phase (Microneedling + Topical application of Human placenta extract formulation / PRP sessions): (Session 1 at Week 0, Session 2 at Week 4, and Session 3 at Week 8) Follow-up and Final Assessment Phase: (Final evaluation at Week 12) following the third intervention session.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  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

 
 
ExclusionCriteria 
Details  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

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Objective:
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.
 
1 YEAR 
 
Secondary Outcome  
Outcome  TimePoints 
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.
 
1 YEAR 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [zealnmithani@gmail.com].

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 01-08-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

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.
 
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