The Suitability of Tience® for Treating Acne Scars

NCT07368764 | Recruiting

• 1 other identifier: CT-009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  180 days

Secondary Outcomes (3)

• The adverse reactions and adverse events assessment questionnaire for the participants

  Assessment will be conducted 7 days after each treatment.

• Descriptive safety evaluation of the researcher including incidence rates of adverse events

  180 days

• The adverse reactions and events assessment questionnaire for the researcher

  Day 0 the first treatment, Day 30 the second treatment, and Day 90 the third treatment.

Study Arms (1)

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.

Procedure: Intradermal injections

Interventions

Intradermal injections PROCEDURE

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

Intradermal injections of Tience® cell-free allogeneic adipose tissue product

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Linio Biotech Oy: lead
• Clinius Ltd: collaborator

Study Sites (1)

Aava Kamppi Medical Centre

Helsinki, 001000, Finland

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris; Lymphoma, Follicular; Skin Diseases

Interventions

Injections, Intradermal

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Laura Bouchard, MD, PhD

  Aava Kamppi Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minna Höst, Coordinator

CONTACT

+358407198476; minna.host@linio-biotech.com

Laura Bouchard, MD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Enrolled participants will be pseudorandomized to receive 3 Tience® Intradermal injection treatments to either the left or right facial half.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 27, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)