Skin ManifestationsKarismaNCT06152718
New Regenerative Approach for Dermal Renovation (Karisma)
A study testing Karisma in people with Skin Manifestations, run by University of Palermo at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Manifestations
- What is being tested?
- Karisma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range 20-65 years old
- skin ageing evidences from mild to severe
- not affected by oncological diseases
- rheumatological diseases
- no allergic diseases
- no chronic inflammatory diseases (including dermatitis, psoriasis, etc.). Patients should not have;
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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)
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.
Read the 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:
- smokers (30 subjects)
- non-smokers (30 subjects)
- 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.
- Conditions
- Skin Manifestations
- Being tested
- Karisma
- Keywords
- regenerative medicine, skin ageing, collagen production, filler, Hyaluronic acid, inflammation
- Medical subject headings
- Skin Manifestations, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarismaOther
Use of regenerative capabilities of a new medical device focused on dermal redensification, induced by injections of single-strand alpha 1 collagen
| Study group | Role | What they receive |
|---|---|---|
| Karisma arm | Experimental | Selected participant (inclusion criteria) undergo one injection of single-strand alpha 1 collagen (3ml) Receives: Other: Karisma |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Change from Baseline to day 15 in the mean depth of skin wrinkles (mm)
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.
Measured: baseline and day 15
"Change from Baseline to day 30 in the mean depth of skin wrinkles (mm)
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.
Measured: baseline and day 30
"Change from Baseline to day 60 in the mean depth of skin wrinkles (mm)
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.
Measured: baseline and day 60
"Change from Baseline to day 15 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
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
Measured: baseline and day 15
"Change from Baseline to day 30 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
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
Measured: baseline and day 30
"Change from Baseline to day 60 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
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
Measured: baseline and day 60
"Change from Baseline to day 15 in hemoglobin quantity.
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
Measured: baseline and day 15
"Change from Baseline to day 30 in hemoglobin quantity.
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
Measured: baseline and day 30
"Change from Baseline to day 60 in hemoglobin quantity.
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
Measured: baseline and day 60
"Change from Baseline in the Mean values of FACE-Q questionnaire at 15 days"
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).
Measured: baseline and day 15
"Change from Baseline in the Mean values of FACE-Q questionnaire, at 30 days"
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).
Measured: baseline and day 30
"Change from Baseline in the Mean values of FACE-Q questionnaire, at 60 days"
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).
Measured: baseline and day 60
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 15 days"
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.
Measured: baseline and day 15
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 30 days"
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.
Measured: baseline and day 30
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 60 days"
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.
Measured: baseline and day 60
Secondary outcomes (1)
tissue Biopsies
Core needle biopsies to evaluate histological changes in ageing tissues
Measured: baseline and day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Skin ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- the group of researchers will assess partecipants before the intervention (baseline measurement) and then again after the intervention. The change from baseline to the end of the study can be attributed to the intervention.There is no separate control group for comparison.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Sonya Vasto, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152718
- Sponsor's protocol ID
- 49-10-02-2023-1
- Acronym
- Karisma
- Status last verified
- Dec 2023
- First submitted
- 7 Nov 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haddad S, Galadari H, Patil A, Goldust M, Al Salam S, Guida S. Evaluation of the biostimulatory effects and the level of neocollagenesis of dermal fillers: a review. Int J Dermatol. 2022 Oct;61(10):1284-1288. doi: 10.1111/ijd.16229. Epub 2022 Apr 29.
PubMed 35486036Fallacara A, Manfredini S, Durini E, Vertuani S. Erratum: Hyaluronic Acid Fillers in Soft Tissue Regeneration. Facial Plast Surg. 2017 Apr;33(2):244. doi: 10.1055/s-0037-1601851. Epub 2017 Apr 7. No abstract available.
PubMed 28388806Kapoor KM, Saputra DI, Porter CE, Colucci L, Stone C, Brenninkmeijer EEA, Sloane J, Sayed K, Winaya KK, Bertossi D. Treating Aging Changes of Facial Anatomical Layers with Hyaluronic Acid Fillers. Clin Cosmet Investig Dermatol. 2021 Aug 26;14:1105-1118. doi: 10.2147/CCID.S294812. eCollection 2021.
PubMed 34471372Bukhari SNA, Roswandi NL, Waqas M, Habib H, Hussain F, Khan S, Sohail M, Ramli NA, Thu HE, Hussain Z. Hyaluronic acid, a promising skin rejuvenating biomedicine: A review of recent updates and pre-clinical and clinical investigations on cosmetic and nutricosmetic effects. Int J Biol Macromol. 2018 Dec;120(Pt B):1682-1695. doi: 10.1016/j.ijbiomac.2018.09.188. Epub 2018 Oct 1.
PubMed 30287361Vasvani S, Kulkarni P, Rawtani D. Hyaluronic acid: A review on its biology, aspects of drug delivery, route of administrations and a special emphasis on its approved marketed products and recent clinical studies. Int J Biol Macromol. 2020 May 15;151:1012-1029. doi: 10.1016/j.ijbiomac.2019.11.066. Epub 2019 Nov 9.
PubMed 31715233Iaconisi GN, Lunetti P, Gallo N, Cappello AR, Fiermonte G, Dolce V, Capobianco L. Hyaluronic Acid: A Powerful Biomolecule with Wide-Ranging Applications-A Comprehensive Review. Int J Mol Sci. 2023 Jun 18;24(12):10296. doi: 10.3390/ijms241210296.
PubMed 37373443Ricard-Blum S. The collagen family. Cold Spring Harb Perspect Biol. 2011 Jan 1;3(1):a004978. doi: 10.1101/cshperspect.a004978.
PubMed 21421911Avila Rodriguez MI, Rodriguez Barroso LG, Sanchez ML. Collagen: A review on its sources and potential cosmetic applications. J Cosmet Dermatol. 2018 Feb;17(1):20-26. doi: 10.1111/jocd.12450. Epub 2017 Nov 16.
PubMed 29144022Chattopadhyay S, Raines RT. Review collagen-based biomaterials for wound healing. Biopolymers. 2014 Aug;101(8):821-33. doi: 10.1002/bip.22486.
PubMed 24633807Rapaport MJ, Salit R, Rivkin L. Collagen injections for aging skin lines (wrinkles). J Am Acad Dermatol. 1984 Aug;11(2 Pt 1):250-2. doi: 10.1016/s0190-9622(84)70159-9.
PubMed 6480926Lucey P, Goldberg DJ. Complications of collagen fillers. Facial Plast Surg. 2014 Dec;30(6):615-22. doi: 10.1055/s-0034-1396904. Epub 2014 Dec 23.
PubMed 25536127Cui Y, Wang F, Voorhees JJ, Fisher GJ. Rejuvenation of Aged Human Skin by Injection of Cross-linked Hyaluronic Acid. Plast Reconstr Surg. 2021 Jan 1;147(1S-2):43S-49S. doi: 10.1097/PRS.0000000000007620.
PubMed 33347074Wells JM, Gaggar A, Blalock JE. MMP generated matrikines. Matrix Biol. 2015 May-Jul;44-46:122-9. doi: 10.1016/j.matbio.2015.01.016. Epub 2015 Jan 28.
PubMed 25636538Maquart FX, Bellon G, Pasco S, Monboisse JC. Matrikines in the regulation of extracellular matrix degradation. Biochimie. 2005 Mar-Apr;87(3-4):353-60. doi: 10.1016/j.biochi.2004.10.006.
PubMed 15781322Wu GT, Kam J, Bloom JD. Hyaluronic Acid Basics and Rheology. Facial Plast Surg Clin North Am. 2022 Aug;30(3):301-308. doi: 10.1016/j.fsc.2022.03.004.
PubMed 35934432
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06152718
- Acronym / sponsor ID
- Karisma / 49-10-02-2023-1
- Conditions
- Skin Manifestations
- Keywords
- regenerative medicine, skin ageing, collagen production, filler, Hyaluronic acid, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- 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
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- smokers (30 subjects)
- non-smokers (30 subjects)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- the group of researchers will assess partecipants before the intervention (baseline measurement) and then again after the intervention. The change from baseline to the end of the study can be attributed to the intervention.There is no separate control group for comparison.
| Arm | Type | Receives |
|---|---|---|
| Karisma arm | Experimental | Other: KarismaSelected participant (inclusion criteria) undergo one injection of single-strand alpha 1 collagen (3ml) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age range 20-65 years old
- skin ageing evidences from mild to severe
- not affected by oncological diseases
- rheumatological diseases
- no allergic diseases
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KarismaUse of regenerative capabilities of a new medical device focused on dermal redensification, induced by injections of single-strand alpha 1 collagen | Other | Karisma arm |
Primary outcome
"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.
"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.
"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.
"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
"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
"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
"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
"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
"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
"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).
"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).
"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).
"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.
"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.
"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.
1 secondary outcome
tissue Biopsies
Time frame: baseline and day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 35486036Haddad S, Galadari H, Patil A, Goldust M, Al Salam S, Guida S. Evaluation of the biostimulatory effects and the level of neocollagenesis of dermal fillers: a review. Int J Dermatol. 2022 Oct;61(10):1284-1288. doi: 10.1111/ijd.16229. Epub 2022 Apr 29.
- Background: PubMed 28388806Fallacara A, Manfredini S, Durini E, Vertuani S. Erratum: Hyaluronic Acid Fillers in Soft Tissue Regeneration. Facial Plast Surg. 2017 Apr;33(2):244. doi: 10.1055/s-0037-1601851. Epub 2017 Apr 7. No abstract available.
- Background: PubMed 34471372Kapoor KM, Saputra DI, Porter CE, Colucci L, Stone C, Brenninkmeijer EEA, Sloane J, Sayed K, Winaya KK, Bertossi D. Treating Aging Changes of Facial Anatomical Layers with Hyaluronic Acid Fillers. Clin Cosmet Investig Dermatol. 2021 Aug 26;14:1105-1118. doi: 10.2147/CCID.S294812. eCollection 2021.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Karisma in people with Skin Manifestations, run by University of Palermo at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Change from Baseline to day 15 in the mean depth of skin wrinkles (mm) (time frame: baseline and day 15). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06152718, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.