AcneNCT07368764
The Suitability of Tience® for Treating Acne Scars
A study testing Intradermal injections in people with Acne and Acne Scars, run by Linio Biotech Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne, Acne Scars
- What is being tested?
- Intradermal injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 1 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acne, Acne Scars
- Being tested
- Intradermal injections
- Keywords
- acne scars, skin regeneration, skin regeneration treatment, substance of human origin, the healing of damaged skin, moderate, severe acne scars, skin diseases, Acne Vulgaris
- Medical subject headings
- Acne Vulgaris, Lymphoma, Follicular, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal injectionsProcedure or surgery
Three treatment sessions involving intradermal injections of the Tience cell-free allogeneic adipose tissue product administered to one side of the face.
| Study group | Role | What they receive |
|---|---|---|
| Intradermal injections of Tience® cell-free allogeneic adipose tissue product | Experimental | Split face, Intradermal injections of Tience® cell-free allogeneic adipose tissue product on one side of the face. Receives: Procedure: Intradermal injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postacne Scarring: A Qualitative Global Scarring Grading System (Goodman and Baron)
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.
Measured: 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)
Visia® Gen7 Skin Analysis System
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.
Measured: Before first treatment, Day 30 before second treatment, Day 90 before third treatment, and Day 180 evaluation visit.
Self assessment of study participants
Subjective self-assessment of acne scars by study participants before each treatment and at the final evaluation visit.
Measured: 180 days
Secondary outcomes (3)
The adverse reactions and adverse events assessment questionnaire for the participants
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.
Measured: Assessment will be conducted 7 days after each treatment.
Descriptive safety evaluation of the researcher including incidence rates of adverse events
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.
Measured: 180 days
The adverse reactions and events assessment questionnaire for the researcher
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.
Measured: Day 0 the first treatment, Day 30 the second treatment, and Day 90 the third treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 May 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Enrolled participants will be pseudorandomized to receive 3 Tience® Intradermal injection treatments to either the left or right facial half.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linio Biotech Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinius Ltd
- Responsible party
- Sponsor
- Investigators
- Laura Bouchard, MD, PhD, Principal investigator, Aava Kamppi Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368764
- Sponsor's protocol ID
- CT-009
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Suitability of Tience® for the Treatment of Acne Scars
- ClinicalTrials.gov ID
- NCT07368764
- Acronym / sponsor ID
- CT-009
- Conditions
- Acne, Acne Scars
- Keywords
- acne scars, skin regeneration, skin regeneration treatment, substance of human origin, the healing of damaged skin, moderate, severe acne scars, skin diseases, Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Linio Biotech OyIndustry (pharma, biotech, devices)
- Collaborators
- Clinius Ltd
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Enrolled participants will be pseudorandomized to receive 3 Tience® Intradermal injection treatments to either the left or right facial half.
| Arm | Type | Receives |
|---|---|---|
| Intradermal injections of Tience® cell-free allogeneic adipose tissue product | Experimental | Procedure: Intradermal injectionsSplit face, Intradermal injections of Tience® cell-free allogeneic adipose tissue product on one side of the face. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal injectionsThree treatment sessions involving intradermal injections of the Tience cell-free allogeneic adipose tissue product administered to one side of the face. | Procedure or surgery | Intradermal injections of Tience® cell-free allogeneic adipose tissue product |
Primary outcome
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.
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.
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.
3 secondary outcomes
The adverse reactions and adverse events assessment questionnaire for the participants
Time frame: 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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Bouchard, MD, PhD principal investigator
Aava Kamppi Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradermal injections in people with Acne and Acne Scars, run by Linio Biotech Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.