The Suitability of Tience® for Treating Acne Scars

Linio Biotech Oy

Status: Enrolling

Conditions: Acne Scars; Acne

Treatments: Procedure: Intradermal injections

Study type: Interventional

Funder types: Industry

Identifiers

NCT07368764

CT-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: healthy volunteers aged 18-40 years who have at least 3-year- old acne scars on their cheeks.

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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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

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

Experimental group

Description:

Split face, Intradermal injections of Tience® cell-free allogeneic adipose tissue product on one side of the face.

Treatment:

Procedure: Intradermal injections