FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/101921 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Topical application ]  
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Polydeoxyribonucleotide (PDRN) for Hair Regeneration 
Scientific Title of Study   Clinical Interventional Study to Assess the Effectiveness of Polydeoxyribonucleotide (PDRN) for Hair Regeneration 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anannya S  
Designation  Consultant Dermatologist 
Affiliation  RENDER SKIN AND HAIR  
Address  RENDER SKIN and HAIR, Canberra House, 97, Pantheon Rd, Egmore, Chennai, Tamil Nadu 600008

Chennai
TAMIL NADU
600008
India 
Phone  9445887101  
Fax    
Email  dranannya@renderclinic.com  
 
Details of Contact Person
Scientific Query
 
Name  Anannya S  
Designation  Consultant Dermatologist 
Affiliation  RENDER SKIN AND HAIR  
Address  RENDER SKIN and HAIR, Canberra House, 97, Pantheon Rd, Egmore, Chennai, Tamil Nadu 600008


TAMIL NADU
600008
India 
Phone  9445887101  
Fax    
Email  dranannya@renderclinic.com  
 
Details of Contact Person
Public Query
 
Name  Anannya S  
Designation  Consultant Dermatologist 
Affiliation  RENDER SKIN AND HAIR  
Address  RENDER SKIN and HAIR, Canberra House, 97, Pantheon Rd, Egmore, Chennai, Tamil Nadu 600008


TAMIL NADU
600008
India 
Phone  9445887101  
Fax    
Email  dranannya@renderclinic.com  
 
Source of Monetary or Material Support  
SILPHION RESEARCH PRIVATE LIMITED 
 
Primary Sponsor  
Name  SILPHION RESEARCH PRIVATE LIMITED 
Address  No. 95/44, 4th Floor, I Main Road, Gandhi Nagar, Adyar, Chennai- 600020 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Anannya S  RENDER SKIN AND HAIR   RENDER SKIN and HAIR, Canberra House, 97, Pantheon Rd, Egmore, Chennai, Tamil Nadu 600008
Chennai
TAMIL NADU 
759-893-1091

dranannya@renderclinic.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INDEPENDENT ETHICS COMMITTEE, RENDER SKIN AND HAIR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L649||Androgenic alopecia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Topical Polydeoxyribonucleotide (PDRN) serum   Topical PDRN serum application immediately following nanofusion (scalp stimulation by microneedling), once weekly for 8 sessions. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Clinically diagnosed androgenetic alopecia with Hamilton Norwood grade two to grade five for men and Ludwig grade one to grade two for women.
2. Willingness to comply with protocol and follow-up visits. 
 
ExclusionCriteria 
Details  1. Pregnancy or lactation.
2. Known hypersensitivity to PDRN or excipients.
3. Active scalp infection or inflammatory dermatoses.
4. Concurrent hair restoration procedures, medications or supplements.
5. Systemic or autoimmune conditions influencing hair growth. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in hair density (Trichoscopy assessment).  Baseline, Week 4, Week 8 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in Investigator Global Assessment
2. Patient Self-Assessment Questionnaire (10 point Visual
Analogue Scale evaluating satisfaction with density, texture, and overall aesthetic
improvement Standardized Photography (frontal, vertex, both profiles) 
Baseline, Week 4, Week 8 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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   N/A 
Date of First Enrollment (India)   02/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a prospective, open-label, single-arm interventional study designed to evaluate the efficacy and safety of topical Polydeoxyribonucleotide (PDRN) for hair regeneration in patients with mild-to-moderate androgenetic alopecia (AGA).

A total of 25 participants aged 25–60 years with clinically diagnosed AGA (Hamilton–Norwood grades II–V in men and Ludwig grades I–II in women) will be enrolled. A single 1 cm2 circular target area will be selected and documented for each participant for trichoscopic assessment. For male participants the vertex (mid-vertex) will be selected and for female participants the left frontoparietal area will be used. The exact location will be marked with a sterile 1 mm permanent micro-tattoo dot placed at the superior border of the 1 cm2 circle to ensure exact repositioning. The coordinates (distance from external occipital protuberance / glabella) will be recorded in the CRF. Hair density (non-vellus hairs/cm2) will be measured within the tattooed 1 cm2 area using trichoscopy. Participants will undergo weekly scalp nanofusion (microneedling) followed by topical PDRN serum application for 8 sessions.

Efficacy will be assessed using trichoscopy-based hair density measurements, Investigator Global Assessment (IGA), and Patient Self-Assessment (PSA) scales at baseline, week 4, and week 8. Standardized clinical photography will be used to document improvement. Safety assessments and monitoring for adverse events will be performed at each session.

Data will be analyzed using SPSS software, with primary endpoints including change in hair density and secondary endpoints including global assessment scores and patient satisfaction indices.

 
Close