| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [zealnmithani@gmail.com].
- 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.
- 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. |