New Regenerative Approach for Dermal Renovation (Karisma)

Active, not recruiting

• Conditions: Skin Manifestations

• Registration Number: NCT06152718
• Lead Sponsor: University of Palermo

Brief Summary

Purpose/Objectives of the Study: Regenerative medicine, as well as aesthetic plastic surgery and dermatology field persistently seeks innovative, minimally invasive interventions to enhance skin quality and mitigate signs of aging. This study evaluates the regenerative capabilities of a new medical device focused on dermal redensification, induced by injections of single-strand alpha 1 collagen, to verify its ability, in a specific formulation (contained within a matrix of hyaluronic acid and carboxymethylcellulose), to induce dermal stimulation in both scar outcomes and regenerative medicine applied to skin aging.

Detailed Description

Study Population (including any inclusion/exclusion criteria): : A total of 100 patients, aged between 25 and 70 years of both sexes, subdivided into 3 demographically similar subgroups, will be assessed in this exploratory study. The intervention entailed the administration of the single-strand alpha 1 collagen - hyaluronic acid soft filler, with subsequent evaluations employing the Antera 3D® skin scanner and two multiple choice questionnaires, FACE-Q and Global Aesthetic Improvement Scale (GAIS) to obtain objective data and subjective evaluations recorded by patients. All patients must be in good general health. not affected by oncological, rheumatological, chronic inflammatory diseases (including dermatitis, psoriasis, etc.). patients should not take systemic drugs during the course of the aforementioned study. The sample size of 100 patients is in line with studies already carried out in this field, in order to obtain adequate statistical power, also in anticipation of a physiological drop out of some patients. Parametric and non-parametric tests will be used to test the results to assess the significance of discrete and continuous numerical variables, as well as descriptive statistics for all patient groups.

Within the scope of this project, the investigators plan to recruit four cohorts of subjects:

1. smokers (30 subjects)

2. non-smokers (30 subjects)

3. subjects affected by acne scars (40)

All patients must be in general good health, not affected by oncological, rheumatological, allergic, chronic inflammatory diseases (including dermatitis, psoriasis, etc.). Patients should not have metabolic or cardiovascular diseases, should not have received other injections of hyaluronic acid or similar substances for at least 6 months before the start of treatment, and should not take systemic drugs during the study.

The primary endpoints will be those to evaluate the subjective changes in texture, hydration, compactness, brightness, and quality of skin roughness through the administration of multiple-choice tests already validated by numerous scientific studies (Global Aesthetic Improvement Scale GAIS; FACE-Q Age Appearance Appraisal) and objective changes through non-invasive measurements, such as dermal thickness by high-frequency ultrasound; the depth of wrinkles, amount of melanin and hemoglobin through 3D Antera Scanner, to assess the regenerative capabilities of the medical device in patients affected by acne scars, in the atrophic and dystrophic skin alterations of the body, as well as in the photo and chronoaging of the skin of the face, neck, and décolleté in smoking and non-smoking patients. As a secondary endpoint, it will be analyzed through a Raman spectroscope whether the changes induced by the product will be able to modify the local skin oxidative-reductive picture through spectroscopic analysis on the skin of dermal carotenoids.

Study Procedures: Participants will undergo the following tests :

t0: instrumental evaluation, initial parameter recording, administration of clinical evaluation tests, photographic iconography, and first injection of Karisma.

t1: first check after 15 days, instrumental evaluation, administration of clinical evaluation tests, photographic iconography.

t2: second check 30 days after the first injection of Karisma, instrumental evaluation, administration of clinical evaluation tests, photographic iconography, second injection of Karisma.

t3: third check 60 days after the first injection of Karisma, instrumental evaluation, administration of clinical evaluation tests, photographic iconography.

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-21
• Primary Completion: 2023-11-30
• Status Verified: 2023-12
• Study First Posted: 2023-12-01
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age range 20-65 years old
• skin ageing evidences from mild to severe

Exclusion Criteria

• not affected by oncological diseases
• rheumatological diseases
• allergic diseases
• chronic inflammatory diseases (including dermatitis, psoriasis, etc.). Patients should not have;
• metabolic diseases
• cardiovascular diseases,
• should not have received other injections of hyaluronic acid or similar substances for at least 6 months before the start of treatment,
• should not take systemic drugs during the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
"Change from Baseline to day 60 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)	baseline and day 60	changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar; Melanin values are expressed in arbitrary values ranging from 0.1 to 1
"Change from Baseline in the Mean values of FACE-Q questionnaire at 15 days"	baseline and day 15	FACE-Q questionnaire is a validated multiple choices questionnaire used to assess patient aging appraisaland perceived skin quality of face and neck. Test will be provided to patients at baseline and after 15 days in order to evaluate if any perceived changes are present. 47 questions will be provided. Every question has a 4 values answer ranging from 1 (I.E. very dissatisfied) to 4 (I.E. very satisfied).
"Change from Baseline to day 60 in hemoglobin quantity.	baseline and day 60	changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure hemoglobin values that are expressed in arbitrary values ranging from 0.1 to 4
"Change from Baseline in the Mean values of FACE-Q questionnaire, at 30 days"	baseline and day 30	FACE-Q questionnaire is a validated multiple choices questionnaire used to assess patient aging appraisaland perceived skin quality of face and neck. Test will be provided to patients at baseline and after 15 days in order to evaluate if any perceived changes are present. 47 questions will be provided. Every question has a 4 values answer ranging from 1 (I.E. very dissatisfied) to 4 (I.E. very satisfied).
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 30 days"	baseline and day 30	The GAIS Global Aesthetic Improvement Scale, is a validated five-point scale for assessing global aesthetic improvement in appearence compared to pretratment. The ratings range from "very much improved", "much improved" "improved", unchanged and worsened.
"Change from Baseline to day 15 in the mean depth of skin wrinkles (mm)	baseline and day 15	changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar, in a portion of skin selected by the investigator. skin depth is expressed in millimeters.
"Change from Baseline to day 30 in the mean depth of skin wrinkles (mm)	baseline and day 30	changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar, in a portion of skin selected by the investigator. skin depth is expressed in millimeters.
"Change from Baseline to day 15 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)	baseline and day 15	changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar; Melanin values are expressed in arbitrary values ranging from 0.1 to 1
"Change from Baseline to day 15 in hemoglobin quantity.	baseline and day 15	changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure hemoglobin values that are expressed in arbitrary values ranging from 0.1 to 4
"Change from Baseline to day 60 in the mean depth of skin wrinkles (mm)	baseline and day 60	changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar, in a portion of skin selected by the investigator. skin depth is expressed in millimeters.
"Change from Baseline to day 30 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)	baseline and day 30	changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure depth of skin lines, wrinkles and acne scar; Melanin values are expressed in arbitrary values ranging from 0.1 to 1
"Change from Baseline to day 30 in hemoglobin quantity.	baseline and day 30	changes will be evaluated using 3D Antera Scanner. It is a validated skin device that is used to measure hemoglobin values that are expressed in arbitrary values ranging from 0.1 to 4
"Change from Baseline in the Mean values of FACE-Q questionnaire, at 60 days"	baseline and day 60	FACE-Q questionnaire is a validated multiple choices questionnaire used to assess patient aging appraisaland perceived skin quality of face and neck. Test will be provided to patients at baseline and after 15 days in order to evaluate if any perceived changes are present. 47 questions will be provided. Every question has a 4 values answer ranging from 1 (I.E. very dissatisfied) to 4 (I.E. very satisfied).
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 15 days"	baseline and day 15	The GAIS Global Aesthetic Improvement Scale, is a validated five-point scale for assessing global aesthetic improvement in appearence compared to pretratment. The ratings range from "very much improved", "much improved" "improved", unchanged and worsened.
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 60 days"	baseline and day 60	The GAIS Global Aesthetic Improvement Scale, is a validated five-point scale for assessing global aesthetic improvement in appearence compared to pretratment. The ratings range from "very much improved", "much improved" "improved", unchanged and worsened.

Trial Locations

Locations (2)

NabBio; 🇮🇹 Palermo, PA, Italy

University of Novi Sad, Serbia; 🇷🇸 Novi Sad, Serbia