The Suitability of Tience® for Treating Acne Scars

January 26, 2026 updated by: Linio Biotech Oy

The Suitability of Tience® for the Treatment of 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tience®, a human adipose tissue derivative, is intended to be used in the human body for its original purpose to supplement and replace local extracellular matrix deficiencies in soft tissue, including skin. Tience provides a temporary conductive environment into the injured area. This facilitates the ability of local cells to re-populate the damaged soft tissue and skin area, thereby enabling the deposition of extracellular matrix and repair of the tissue. Tience is authorized for treatment of wounds, scars and soft tissue defects.

The purpose of this study is to determine whether the product is suitable for the treatment of acne scars, and to collect safety data on the use of Tience® in this indication.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Laura Bouchard, MD, PhD

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 its ingredients
  • smoke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intradermal injections of Tience® cell-free allogeneic adipose tissue product
Split face, Intradermal injections of Tience® cell-free allogeneic adipose tissue product on one side of the face.
Procedure: Intradermal injections
Three treatment sessions involving intradermal injections of the Tience cell-free allogeneic adipose tissue product administered to one side of the face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visia® Gen7 Skin Analysis System
Time Frame: Before first treatment, Day 30 before second treatment, Day 90 before third treatment, and Day 180 evaluation visit.
A Visia Gen7 skin analysis will be performed on the study participants before each treatment and at final evaluation visit 180 days after first treatment.
Before first treatment, Day 30 before second treatment, Day 90 before third treatment, and Day 180 evaluation visit.
Self assessment of study participants
Time Frame: 180 days
Subjective self-assessment of acne scars by study participants before each treatment and at the final evaluation visit.
180 days
Postacne Scarring: A Qualitative Global Scarring Grading System (Goodman and Baron)
Time Frame: Participants are evaluated at four time points: Day 0 (prior to the first treatment), Day 30 (prior to the second treatment), Day 90 (prior to the third treatment), and Day 180 (final evaluation visit)

The researcher will grade the participants' acne scars before treatments, and at final evaluation visit using the Goodman and Baron qualitative and quantitative acne scar scales.

For the Goodman and Baron quantitative scar scale, scars will be categorized according to morphology by recording the number of mild, moderate, severe, and hypertrophic lesions. A total score (range: 0-84), with higher scores indicating greater severity and number of scars.

For the Goodman and Baron qualitative scar scale, scars will be classified into four categories: Grade 1= macular, Grade 2= mild, Grade 3= moderate, and Grade 4= severe.
Participants are evaluated at four time points: Day 0 (prior to the first treatment), Day 30 (prior to the second treatment), Day 90 (prior to the third treatment), and Day 180 (final evaluation visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The adverse reactions and adverse events assessment questionnaire for the participants
Time Frame: Assessment will be conducted 7 days after each treatment.
The questionnaire for the study participants of the side effects 7 days after each treatment. Parameters: itching, edema, bruising, tingling, pinpoint bleeding, erythema, needle marks, injection site pain, allergic reaction, skin tenderness, dizziness or feeling unwell during the treatment. The evaluation is conducted using a scale from 0 to 10, where 0 indicates no symptoms and 10 indicates the most severe possible symptoms, along with the duration of the symptoms.
Assessment will be conducted 7 days after each treatment.
Descriptive safety evaluation of the researcher including incidence rates of adverse events
Time Frame: 180 days
All adverse events related to study product or its administration, incidence of AEs, withdrawals due to AEs and all Serious Adverse Events (SAEs) will be assessed. All adverse events will be reported and followed until resolved.
180 days
The adverse reactions and events assessment questionnaire for the researcher
Time Frame: Day 0 the first treatment, Day 30 the second treatment, and Day 90 the third treatment.
The questionnaire for the researcher of the side effects after each treatment. Parameters: edema, bruising, pinpoint bleeding, erythema, injection site pain, allergic reaction. The evaluation is conducted using a scale from 0 to 10, where 0 indicates no symptoms and 10 indicates the most severe possible symptoms of the study participants.
Day 0 the first treatment, Day 30 the second treatment, and Day 90 the third treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linio Biotech Oy

Collaborators

Clinius Ltd

Investigators

  • Principal Investigator: Laura Bouchard, MD, PhD, Aava Kamppi Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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