The Suitability of Tience® for Treating Acne Scars

About this trial

Last updated 3 months ago

Study ID

CT-009

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 40 Years

All Sexes

Trial Timing

Started a year ago

What is this trial 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.

What are the Participation Requirements?

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