RecruitingNot ApplicableNCT07368764

The Suitability of Tience® for Treating Acne Scars

The Suitability of Tience® for the Treatment of Acne Scars

Sponsor

Linio Biotech Oy

Enrollment

20 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Acne Acne Scars

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.

Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device or product called Tience for treating acne scars on the cheeks of healthy adults. The goal is to evaluate how safe and effective it is at improving the appearance of scars left over from past acne. **You may be eligible if...** - You are a healthy volunteer between 18 and 40 years old - You have acne scars on your cheeks that are at least 3 years old - Your skin tone is on the lighter end of the Fitzpatrick scale (types 1–3) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have or are being treated for cancer - You have an active skin disease, active acne, or active herpes - You have a tendency toward excessive scarring (keloids) or hives - You take medications that suppress the immune system or use biologics - You have a bleeding or clotting disorder - You are allergic to the study product - You have recently used strong acne medication like isotretinoin (Accutane) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntradermal injections

Three treatment sessions involving intradermal injections of the Tience cell-free allogeneic adipose tissue product administered to one side of the face.

Locations(1)

Aava Kamppi Medical Centre

Helsinki, Finland

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NCT07368764

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