The Suitability of Tience® for Treating Acne Scars
This is an open-label, single-center, split-face, pseudo-randomized clinical trial designed to evaluate the efficacy and safety of a human-derived, cell-free adipose tissue derivative (Tience® ), for treating moderate to severe acne scars. Participants will receive three treatment sessions over a three-month period: on
| Condition(s) | Acne, Acne Scars |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is an open-label, single-center, split-face, pseudo-randomized clinical trial designed to evaluate the efficacy and safety of a human-derived, cell-free adipose tissue derivative (Tience® ), for treating moderate to severe acne scars. Participants will receive three treatment sessions over a three-month period: on Day 0, Day 30, and Day 90. Treatment will be administered via injections to acne-scarred areas on one side of the face. The untreated side will be treated after the follow-up period. Outcomes will be evaluated over a twelve-month period using investigator clinical assessments, patient self-evaluation and VISIA skin analysis system to monitor changes in scar severity and overall skin quality. |
| Who can participate | Inclusion Criteria: healthy volunteers aged 18-40 years who have at least 3-year- old acne scars on their cheeks. \- Exclusion Criteria: * pregnancy or nursing * cancer or ongoing cancer treatment * an active skin disease * Fitzpatric scale 4-6 skin type * a strong medication used for treating severe acne (e.g., Isotretinoin) * active acne or Herpes * antihistamine medication (if the medication can be paused for 7 days during study visits, participation is possible) * use of biological medications * tendency for excessive scar formation * tendency for urticaria (hives) * systemic medication affecting immunity * autoimmune disease * known disease affecting blood clotting (bleeding or thrombosis tendency) (e.g., von Willebrand disease) * are allergic to the product being studied or any of it |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Lead sponsor | Linio Biotech Oy |
| Locations | Helsinki, Finland |
| Start date | 2025-05-01 |
| NCT ID | NCT07368764 |
| Official listing | https://clinicaltrials.gov/study/NCT07368764 |