None listed
Conditions
Interventions
Intervention1: Polydeoxyribonucleotide: For hyperpigmentation: Intradermal injections of PDRN (dose defined by product labeling) into affected facial areas every 2 weeks, total 4 sessions.
For hair re
modifiable as per skin tolerance). Immediately post-RF, PDRN gel will be applied to the right side of the face. Both sides will receive identical post-procedure care, including sunscreen application.
Sponsors
Silphion Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy volunteers aged 18 to 60 years Fitzpatrick skin type III-VI Willingness to comply with study protocols and visits No topical, systemic or procedural treatments should have been done in past 3 months, other than sunscreen application. No active skin infection or inflammatory condition at treatment sites.
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women Known hypersensitivity to components of PDRN formulations History of keloid formation or hypertrophic scarring Systemic illness likely to interfere with assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Melanin Index (measured by Dermalab Combo) from baseline to week 8 Timepoint: Day 0, Week 4, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in L Index (Dermalab Combo) from baseline to week 8 Investigator-assessed improvement via clinical photographs (5-point scale: 0=no improvement to 4=excellent, 76-100%) at weeks 4 and 8 Improvement via Reveal photography (5-point scale: 0=no improvement to 4=excellent, 76-100%) at weeks 4 and 8.Timepoint: Day 0, Week 4, Week 8 | — |
Countries
India
Contacts
Public ContactDr Savitha Murali
RENDER SKIN AND HAIR
Outcome results
None listed