New Regenerative Approach for Dermal Renovation (Karisma) (Karisma)

January 8, 2026 updated by: Sonya Vasto, University of Palermo

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. Furthermore, tissue biopsy will be colected in order to analyze changes in tissue structure, including collagen deposition and stromal characteristics.

Study Procedures: Participants will undergo the following tests :

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PA
      • Palermo, PA, Italy, 90141
        • NabBio
  • Serbia
    • Serbia
      • Novi Sad, Serbia, Serbia, 21000
        • University of Novi Sad, Serbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

100 patients, aged between 20 and 65 years old of both sexes.

Description

Inclusion Criteria:

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

Inclusion Criteria:

  • not affected by oncological diseases
  • rheumatological diseases
  • no allergic diseases
  • no 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Karisma arm
Selected participant (inclusion criteria) undergo one injection of single-strand alpha 1 collagen (3ml)
Other: Karisma
Use of regenerative capabilities of a new medical device focused on dermal redensification, induced by injections of single-strand alpha 1 collagen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Change from Baseline to day 15 in the mean depth of skin wrinkles (mm)
Time Frame: 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.
baseline and day 15
"Change from Baseline to day 30 in the mean depth of skin wrinkles (mm)
Time Frame: 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.
baseline and day 30
"Change from Baseline to day 60 in the mean depth of skin wrinkles (mm)
Time Frame: 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.
baseline and day 60
"Change from Baseline to day 15 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
Time Frame: 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
baseline and day 15
"Change from Baseline to day 30 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
Time Frame: 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
baseline and day 30
"Change from Baseline to day 60 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
Time Frame: 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
baseline and day 60
"Change from Baseline to day 15 in hemoglobin quantity.
Time Frame: 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
baseline and day 15
"Change from Baseline to day 30 in hemoglobin quantity.
Time Frame: 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
baseline and day 30
"Change from Baseline to day 60 in hemoglobin quantity.
Time Frame: 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
baseline and day 60
"Change from Baseline in the Mean values of FACE-Q questionnaire at 15 days"
Time Frame: 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).
baseline and day 15
"Change from Baseline in the Mean values of FACE-Q questionnaire, at 30 days"
Time Frame: 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).
baseline and day 30
"Change from Baseline in the Mean values of FACE-Q questionnaire, at 60 days"
Time Frame: 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).
baseline and day 60
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 15 days"
Time Frame: 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.
baseline and day 15
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 30 days"
Time Frame: 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.
baseline and day 30
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 60 days"
Time Frame: 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.
baseline and day 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tissue Biopsies
Time Frame: baseline and day 60
Core needle biopsies to evaluate histological changes in ageing tissues
baseline and day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Collaborators

University of Novi Sad, Faculty of Sport and Physical Education
Patrizia Proia, University of Palermo
Filippo Castrogiovanni, Taumedika s.r.l
Antonino De Pasquale, University of Catania
Luigi Di Rosa, University of Palermo
Sara Baldassano, University of Palermo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49-10-02-2023-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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