The Suitability of Tience® for Treating Acne Scars

Linio Biotech Oy20 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acne

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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)

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.

Time frame: 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.

Time frame: 180 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

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