New Regenerative Approach for Dermal Renovation (Karisma)

Skin Manifestations Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06152718
• Other study ID #: 49-10-02-2023-1
• Status: Active, not recruiting
• Start date: August 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: December 2023
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 30, 2024
• Est. primary completion date: November 30, 2023
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Manifestations

Intervention

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

Locations

Country	Name	City	State
Italy	NabBio	Palermo	PA
Serbia	University of Novi Sad, Serbia	Novi Sad

Sponsors (7)

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

Countries where clinical trial is conducted

Italy,  Serbia, 

References & Publications (15)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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