New Regenerative Approach for Dermal Renovation (Karisma)

NCT06152718 | Completed

• 1 other identifier: 49-10-02-2023-1
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

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.

Conditions

Skin Manifestations

Keywords

regenerative medicine; skin ageing; collagen production; filler; Hyaluronic acid; inflammation

Outcome Measures

Primary Outcomes (15)

• "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.

  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.

  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.

  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

  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

  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

  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

  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

  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

  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).

  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).

  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).

  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.

  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.

  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.

  baseline and day 60

Secondary Outcomes (1)

• tissue Biopsies

  baseline and day 60

Study Arms (1)

Karisma arm

EXPERIMENTAL

Selected participant (inclusion criteria) undergo one injection of single-strand alpha 1 collagen (3ml)

Other: Karisma

Interventions

Karisma OTHER

Use of regenerative capabilities of a new medical device focused on dermal redensification, induced by injections of single-strand alpha 1 collagen

Karisma arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

Sponsors & Collaborators

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

Study Sites (2)

NabBio

Palermo, PA, 90141, Italy

Location

University of Novi Sad, Serbia

Novi Sad, Serbia, 21000, Serbia

Location

Related Publications (15)

• 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.

  PMID: 35486036 BACKGROUND

• Fallacara 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.

  PMID: 28388806 BACKGROUND

• Kapoor 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.

  PMID: 34471372 BACKGROUND

• Bukhari 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.

  PMID: 30287361 BACKGROUND

• Vasvani 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.

  PMID: 31715233 BACKGROUND

• Iaconisi 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.

  PMID: 37373443 BACKGROUND

• Ricard-Blum S. The collagen family. Cold Spring Harb Perspect Biol. 2011 Jan 1;3(1):a004978. doi: 10.1101/cshperspect.a004978.

  PMID: 21421911 BACKGROUND

• Avila 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.

  PMID: 29144022 BACKGROUND

• Chattopadhyay S, Raines RT. Review collagen-based biomaterials for wound healing. Biopolymers. 2014 Aug;101(8):821-33. doi: 10.1002/bip.22486.

  PMID: 24633807 BACKGROUND

• Rapaport 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.

  PMID: 6480926 BACKGROUND

• Lucey 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.

  PMID: 25536127 BACKGROUND

• Cui 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.

  PMID: 33347074 BACKGROUND

• Wells 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.

  PMID: 25636538 BACKGROUND

• Maquart 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.

  PMID: 15781322 BACKGROUND

• Wu 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.

  PMID: 35934432 BACKGROUND

MeSH Terms

Conditions

Skin Manifestations; Inflammation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: single-group study cannot blind the occurred intervention: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: December 1, 2023
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 12, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); SE (1)