Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05691049
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2022-12-20
Brief Title:
Evaluation of Efficacy and Safety of HCC_45 for the Correction of Acne Scars of the Face
Sponsor:
IBSA Farmaceutici Italia Srl
Organization:
IBSA Farmaceutici Italia Srl
Study Overview
Official Title:
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
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acne scars represent a frequent complication of moderatesevere 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 thats 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
Atrophic or Depressed Scarring
Ice pick An ice pick scar has a wide shaft that narrows down to the tip It resembles a hole thats 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None