Clinical Interventional Study to Assess the Effectiveness of Polydeoxyribonucleotide (PDRN) for Hair Regeneration

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.