Clinical trial NCT06152718: New Regenerative Approach for Dermal Renovation (Karisma)
Official title: New Regenerative and Anti-aging Medicine Approach Based on Single Strand Alpha-1 Collagen for Neo-collagenesis Induction: Clinical and Instrumental Experience of a New Medical Device for Dermal Regeneration (Karisma)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Skin Manifestations
Keywords: regenerative medicine
skin ageing
collagen production
filler
Hyaluronic acid
Lead sponsor: University of Palermo
Sponsor class: OTHER
Collaborators: name: University of Novi Sad, Faculty of Sport and Physical Education
name: Patrizia Proia, University of Palermo
name: Filippo Castrogiovanni, Taumedika s.r.l
name: Antonino De Pasquale, University of Catania
name: Luigi Di Rosa, University of Palermo
name: Sara Baldassano, University of Palermo
First posted: 2023-12-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients, aged between 20 and 65 years old of both sexes.

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.

Eligibility criteria: 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

Primary outcomes:
measure: "Change from Baseline to day 15 in the mean depth of skin wrinkles (mm)
timeFrame: baseline and day 15
measure: "Change from Baseline to day 30 in the mean depth of skin wrinkles (mm)
timeFrame: baseline and day 30
measure: "Change from Baseline to day 60 in the mean depth of skin wrinkles (mm)
timeFrame: baseline and day 60
measure: "Change from Baseline to day 15 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
timeFrame: baseline and day 15
measure: "Change from Baseline to day 30 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
timeFrame: baseline and day 30
measure: "Change from Baseline to day 60 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
timeFrame: baseline and day 60
measure: "Change from Baseline to day 15 in hemoglobin quantity.
timeFrame: baseline and day 15
measure: "Change from Baseline to day 30 in hemoglobin quantity.
timeFrame: baseline and day 30
measure: "Change from Baseline to day 60 in hemoglobin quantity.
timeFrame: baseline and day 60
measure: "Change from Baseline in the Mean values of FACE-Q questionnaire at 15 days"
timeFrame: baseline and day 15
measure: "Change from Baseline in the Mean values of FACE-Q questionnaire, at 30 days"
timeFrame: baseline and day 30
measure: "Change from Baseline in the Mean values of FACE-Q questionnaire, at 60 days"
timeFrame: baseline and day 60
measure: "Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 15 days"
timeFrame: baseline and day 15
measure: "Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 30 days"
timeFrame: baseline and day 30
measure: "Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 60 days"
timeFrame: baseline and day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: NabBio
state: PA
city: Novi Sad
country: Serbia
facility: University of Novi Sad, Serbia
Study officials:
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