Skin Manifestations Clinical Trial
— KarismaOfficial 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)
Verified date | December 2023 |
Source | University of Palermo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | January 30, 2024 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | NabBio | Palermo | PA |
Serbia | University of Novi Sad, Serbia | Novi Sad |
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 |
Italy, Serbia,
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* Note: There are 15 references in all — Click here to view all references
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 |
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