Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05936437
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-06-13
Brief Title:
Clinical Benefits and Safety of Combined Polynucleotides and Hyaluronic Acid - Newest - for Acne Scars Treatment
Sponsor:
Mastelli Srl
Organization:
Mastelli Srl
Study Overview
Official Title:
An Open-label Study Evaluating the Clinical Benefits and Safety of Combined Polynucleotides and Hyaluronic Acid - Newest - for Acne Scars Treatment
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This clinical study wants to evaluate the efficacy and safety of a medical device combining Polynucleotide Highly Purified Technology PN-HPT and hyaluronic acid Newest-Mastelli Srl for treating moderate-to-severe atrophic post-acne scars
Detailed Description:
This is a prospective open label study aimed to evaluate efficacy and safety of Newest in facial acne scars treatment The study will be conducted at Fatebenefratelli Hospital in Rome Italy All procedures have to be conducted in accordance with the ethical standards of the responsible committee on human experimentation institutional and national and with the Helsinki Declaration of 1975 as revised in 2000 and 2008
A subject will be involved in the study for 6 months and photographs and instrumental assessment Antera 3 D will be performed at 1 months 2 months 3 months and 6 months after first treatment administration results will be compared with basal line evaluation T0
The sample size of 30 patients has been selected based on the previous clinical results obtained from a Preliminary Prospective and Randomized Study of Highly Purified Polynucleotide vs Placebo in Treatment of Moderate to Severe Acne Scars This sample size combined with this study model is statistically sufficient to provide robust estimation of the primary endpoint
The study primary objective is to show the clinical improvement in acne facial scars treated with Newest
The primary end-point of the study is the variation of post-acne scars characteristics evaluated through the Goodman Baron scale at follow up visits FU 3 and FU 6 versus baseline visit T1 At the end of follow-up an average reduction of at least two points of the Goodman score versus baseline will be considered as a positive outcome
A descriptive statistical analysis will illustrate the percentage of patients with different score variation versus basal line
The secondary objectives of the study are the improvement of the skin quality and the safety of the investigational device the secondary end-points are
Centralized evaluation of the photos of scars taken pre- and post-treatment and evaluated by a blinded investigator Optionally the differences pre- and post-treatment in skin roughness texture elasticityhydration colorsevenness vascular features and pore dimensions could be also evaluated by means of 3D pictures Antera 3D or QuantifiCARE
Aesthetic improvement of depressed facial atrophic scars using the Global Aesthetic Improvement Scale GAIS performed by both the patient and the investigator15 the percentage of questionnaire score improvement 2 between the two follow up visits will be considered of a clinical significance
Adverse events AE will be monitored throughout the trial A safety assessment has to be conducted by the investigator at each scheduled visit The intensity mildmoderatesevere will be assessed according to the investigators judgement If a patient drops out of the study the possible reasons for drop-out including no improvement in the scar or occurrence of unacceptable signssymptoms need to be documented
All the screened patients at the baseline visit T0 after checking the inclusionexclusion criteria will be prospectively randomized in the clinical study The Investigator has to grade the post-acne scars severity according to the Goodman Baron classification The eligible patient will undergo the first injection with the study medical device and the investigator shall evaluate the clinical result by the Goodman score At follow up visits the patient and the investigator have to judge the aesthetic improvement of scars by checking the GAIS questionnaire
A total of 4 administrations of the investigational product are scheduled at the baseline visit T1 at T2 T3 and T4 with an interval of 2 weeks from each other The clinical evaluation Goodman score has to be performed in addition to the basal visit T1 also after 3 and 6 months of follow-up respectively
Standardized photographs shall be taken prior to the first injection of the study product and at every study visit in order to document treatment effect A reference basal photo should be taken of each patient with a snapshot of the facial region most damaged by the acne scars A service basal photo on which the shooted damaged facial area is marked out should be the reference photo for further evaluations
Note that no covering make-up should be used on the photographs Each Investigator and other study site personnel designated to take photographs shall be thoroughly trained in the photographic equipment and techniques before study start if applicable
Photographs shall be taken at the baseline visit before treatment T1 If the photographs are considered good quality the Investigator may proceed with treatment of the subject if the photographs are considered not good enough the photography shall be repeated
All snapshot must be taken against a neutral background and artificial light only in same circumstances same perspectiveangle same distance and ideally with the same camera usually using a 5 mega pixel camera and analyzed as for color and pigmentation by a computer program
The subject should keep the eyes closed during photography and shall have a neutral facial expression
A subject will be involved in the study for 6 months and photographs and instrumental assessment Antera 3 D will be performed at 1 months 2 months 3 months and 6 months after first treatment administration results will be compared with basal line evaluation T0
The sample size of 30 patients has been selected based on the previous clinical results obtained from a Preliminary Prospective and Randomized Study of Highly Purified Polynucleotide vs Placebo in Treatment of Moderate to Severe Acne Scars This sample size combined with this study model is statistically sufficient to provide robust estimation of the primary endpoint
The study primary objective is to show the clinical improvement in acne facial scars treated with Newest
The primary end-point of the study is the variation of post-acne scars characteristics evaluated through the Goodman Baron scale at follow up visits FU 3 and FU 6 versus baseline visit T1 At the end of follow-up an average reduction of at least two points of the Goodman score versus baseline will be considered as a positive outcome
A descriptive statistical analysis will illustrate the percentage of patients with different score variation versus basal line
The secondary objectives of the study are the improvement of the skin quality and the safety of the investigational device the secondary end-points are
Centralized evaluation of the photos of scars taken pre- and post-treatment and evaluated by a blinded investigator Optionally the differences pre- and post-treatment in skin roughness texture elasticityhydration colorsevenness vascular features and pore dimensions could be also evaluated by means of 3D pictures Antera 3D or QuantifiCARE
Aesthetic improvement of depressed facial atrophic scars using the Global Aesthetic Improvement Scale GAIS performed by both the patient and the investigator15 the percentage of questionnaire score improvement 2 between the two follow up visits will be considered of a clinical significance
Adverse events AE will be monitored throughout the trial A safety assessment has to be conducted by the investigator at each scheduled visit The intensity mildmoderatesevere will be assessed according to the investigators judgement If a patient drops out of the study the possible reasons for drop-out including no improvement in the scar or occurrence of unacceptable signssymptoms need to be documented
All the screened patients at the baseline visit T0 after checking the inclusionexclusion criteria will be prospectively randomized in the clinical study The Investigator has to grade the post-acne scars severity according to the Goodman Baron classification The eligible patient will undergo the first injection with the study medical device and the investigator shall evaluate the clinical result by the Goodman score At follow up visits the patient and the investigator have to judge the aesthetic improvement of scars by checking the GAIS questionnaire
A total of 4 administrations of the investigational product are scheduled at the baseline visit T1 at T2 T3 and T4 with an interval of 2 weeks from each other The clinical evaluation Goodman score has to be performed in addition to the basal visit T1 also after 3 and 6 months of follow-up respectively
Standardized photographs shall be taken prior to the first injection of the study product and at every study visit in order to document treatment effect A reference basal photo should be taken of each patient with a snapshot of the facial region most damaged by the acne scars A service basal photo on which the shooted damaged facial area is marked out should be the reference photo for further evaluations
Note that no covering make-up should be used on the photographs Each Investigator and other study site personnel designated to take photographs shall be thoroughly trained in the photographic equipment and techniques before study start if applicable
Photographs shall be taken at the baseline visit before treatment T1 If the photographs are considered good quality the Investigator may proceed with treatment of the subject if the photographs are considered not good enough the photography shall be repeated
All snapshot must be taken against a neutral background and artificial light only in same circumstances same perspectiveangle same distance and ideally with the same camera usually using a 5 mega pixel camera and analyzed as for color and pigmentation by a computer program
The subject should keep the eyes closed during photography and shall have a neutral facial expression
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