Treatment of androgenetic alopecia in adult male and female patients experiencing hair thinning and loss due to this condition. Skin and Connective Tissue Diseases
Conditions
Interventions
Participants will be selected based on strict inclusion and exclusion criteria. Eligible participants will include men aged 20 to 60 years with androgenetic alopecia (AGA) classified as Norwood-Hamilt
Sponsors
Ouronyx
Nordberg Medical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged 20 to 60 years 2. Diagnosed with androgenetic alopecia (AGA): 2.1. Men with Norwood-Hamilton classification II-IV 2.2. Women with Ludwig classification I-II 3. Hair loss stabilized for at least 6 months prior to screening 4. Generally healthy with no significant medical conditions that could interfere with the study 5. Able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Presence of other forms of alopecia (e.g., alopecia areata, scarring alopecia) or scalp infections 2. Skin diseases affecting the scalp 3. Use of pharmacological hair growth treatments (e.g., minoxidil, finasteride) or procedures (e.g., PRP therapy) within 6 months prior to screening 4. Known hypersensitivity to PLLA, lidocaine, or any components of Juläine 5. Autoimmune diseases or other medical conditions that could interfere with study outcomes (e.g., uncontrolled diabetes mellitus, active infections, or chronic inflammatory conditions) 6. Coagulation disorders or current use of anticoagulant therapy 7. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding 8. Participation in another clinical trial within 3 months prior to screening 9. Psychiatric or psychological conditions that might compromise participation or affect the interpretation of results 10. Any condition or situation that, in the investigator’s opinion, may interfere with the participant’s ability to comply with the study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hair density improvement, measured using trichoscopy and standardized scalp photography, at baseline, Week 13 (Follow-Up Assessment), and Week 20 (Final Follow-Up) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hair shaft thickness (µm) measured using trichoscopy at baseline, Week 5 (before the second treatment), Week 9 (before the third treatment), and Week 13 (four weeks after the final treatment) 2. Percentage of single follicular units measured using trichoscopy at baseline, Week 5, Week 9, and Week 13 3. Patient-reported quality of life measured using the Dermatology Life Quality Index (DLQI) at baseline, Week 13, and Week 20 4. Overall patient satisfaction with treatment measured using a 10-point Likert scale at Week 13 and Week 20 5. Adverse events monitored and recorded using standardized adverse event reporting forms continuously from baseline to Week 20 | — |
Countries
England, United Kingdom
Contacts
Public ContactEfthyvoulos Sokratous
Outcome results
None listed