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

NCT05691049 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-04-19

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Derming SRL

    collaborator OTHER

  • IBSA Farmaceutici Italia Srl

    lead INDUSTRY

Principal Investigators

  • Adele Sparavigna, MD · DERMING S.r.l., Clinical Research and Bioengineering Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-24
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05691049 on ClinicalTrials.gov