| 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
|
|
|
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
|
|
|
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. |