NCT05691049

Evaluation of Efficacy and Safety of HCC_45 for the Correction of Acne Scars of the Face

Interventional, Post-marketing, Local, Mono-centric Study for Evaluation of Efficacy and Safety of HCC_45 for the Correction of Acne Scars of the Face

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: IBSA Farmaceutici Italia Srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Acne scars represent a frequent complication of moderate/severe acne and may negatively impact on psychosocial and physical well-being of acne patients. Several types of acne scars have been classified and the same patient is likely to have more than one type. Each type can be treated with varying degrees of success. The main acne scars are the following: Atrophic or Depressed Scarring: * Ice pick: An ice pick scar has a wide shaft that narrows down to the tip. It resembles a hole that's wide at the top and narrows to a point as it goes deeper into the skin. Such an indentation is common and one of the most challenging scars to heal. This scar is more frequent on forehead and upper cheeks, where skin is thinner. * Rolling: These scars are typically found on the lower cheeks and jaw, where skin is thicker. The indents have sloping edges that makes the skin look uneven and wavy. * Boxcar: Boxcar scars are indents that have sharper edges. Those edges go down deep into the skin. These scars are common on the lower checks and jaw.

Detailed description

Open label clinical trial, conducted by 1 center under dermatological control. Primary aim of the study is to evaluate the efficacy and the safety of the deep injection of HCC\_45 in acne scars of the face (ice picks, rolling, boxcars). Secondary endpoint is self-assessment questionnaire regarding treatment efficacy and tolerance. HCC\_45 is a resorbable medical device 2 ml nonpyrogenic pre-filled syringe, containing 2 ml of hyaluronic acid for intradermal use. The principal component of the medical device is Hyaluronic Acid of non-animal origin, produced by bacterial fermentation.

Conditions

• Acne Scars - Mixed Atrophic and Hypertrophic
• Ice Pick Scars
• Rolling Scars
• Boxcar Scars

Interventions

Type	Name	Description
DEVICE	HCC_45	Dosage form: HCC\_45 is a resorbable medical device 2 ml non-pyrogenic pre-filled syringe, containing 2 ml of hyaluronic acid for intradermal use. The principal component of the medical device is Hyaluronic Acid of non-animal origin, produced by bacterial fermentation.

Timeline

• Start date: 2022-11-24
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2023-01-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: Italy