Efficacy and Safety of Poly-L-Lactic Acid in Androgenetic Alopecia
Research type
Research Study
Full title
Evaluation of the Efficacy and Safety of Poly-L-Lactic Acid (PLLA) Microspheres in the Treatment of Androgenetic Alopecia: An Open-Label, Investigator-Initiated Pilot Study
IRAS ID
352355
Contact name
Efthyvoulos Sokratous
Contact email
Sponsor organisation
Nordberg Medical AB
Duration of Study in the UK
0 years, 7 months, 28 days
Research summary
Androgenetic alopecia (AGA), commonly known as pattern hair loss, is a condition that affects millions worldwide, causing hair thinning and loss, often leading to psychological distress. Current treatments for AGA, such as medications or hair transplantation, have limitations, prompting the need for novel therapeutic approaches. This study aims to investigate the safety and effectiveness of Juläine, an innovative injectable treatment containing Poly-L-Lactic Acid (PLLA) microspheres, in addressing hair loss associated with AGA. PLLA has been shown to stimulate collagen production and tissue regeneration in other applications, offering potential benefits for scalp health and hair growth.
The study will enroll 20 male and female participants aged 20–60 years who meet specific eligibility criteria, including having stable AGA (classified using the Norwood-Hamilton or Ludwig scales). Participants will receive three scalp injections of Juläine, spaced four weeks apart, with careful follow-up assessments to monitor outcomes.
The main goal of this study is to measure changes in hair density using specialised imaging - Trichoscopy. Secondary outcomes include evaluating hair-shaft thickness, follicular-unit composition, and patient-reported quality-of-life and satisfaction using validated tools like the Dermatology Life Quality Index (DLQI) and a Likert satisfaction scale. Safety will be closely monitored by assessing potential side effects and adverse events throughout the study period.
This open-label pilot study will be conducted at the Ouronyx Clinic in London, a center of excellence in aesthetic medicine. The research is sponsored by Nordberg Medical and overseen by aesthetic medicine physicians at Ouronyx. The study findings may lead to the development of an innovative, minimally invasive treatment for AGA, offering new hope to individuals affected by this condition. If successful, this research could pave the way for larger-scale studies and advance treatment options for hair loss.
REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0032
Date of REC Opinion
31 Mar 2025
REC opinion
Further Information Favourable Opinion