The clinical investigation is designed to primarily confirm the performance of KIO015 in improving the GAIS assessment, a subjective parameter, including skin roughness. A non-treated zone (untreated hemi-face) was used as comparator for exact evaluation of the zones between the treated and untreated ones The safety of KIO015 was also evaluated for confirmation of initial data. For this purpose, 78 healthy subjects were injected in half of the face. In KIO015-PLUM, healthy subjects with signs of cutaneous aging and dehydrated skin on the face received either one or three dermal injections: * Cohort 1: one intradermal injection session of KIO015 device on M0, to evaluate the effect of a single injection session * Cohort 2: three intradermal injection sessions of KIO015 device on M0, M1 and M2, to evaluate the effect of 3 injection sessions as performed for state-of-the-art products.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
Innovative carboxymethyl chitosan-based biomaterial intended for intradermal injection
Eurofins Dermscan Pharmascan
Villeurbanne, France
Global aesthetic improvement with GAIS (Global Aesthetic Improvement Scale)
Clinical evaluation of global aesthetic improvement of the treated area with GAIS (Global Aesthetic Improvement Scale) evaluated by the investigator. Comparison to a non-treated zone.
Time frame: 1 month after the first intradermal injection for both cohorts.
For both cohorts combined, evaluation of cutaneous hydration in a sub-group of subjects not using hydrating agent
Time frame: 1 month after the first intradermal injection
Change from baseline of epidermis hydration with Corneometer®
For each cohort, change from baseline of epidermis hydration of the treated zone measured with Corneometer®
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only) after each injection session.
Change from baseline of dermis hydration with Moisturemeter D®
For each cohort, change from baseline of dermis hydration of the treated zone measured with Moisturemeter D®
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only) after each injection session.
Change from baseline of skin oxidative stress
For each cohort, change from baseline of skin oxidative stress from skin superficial sampling on the treated area at the different time points and comparison to a non-treated zone.
Time frame: 7 days (cohort 1 only), 1 month, 3 months and 6 months after each injection session.
Change from baseline of epidermis hydration compared to a non-treated zone with Corneometer®
Comparison of both cohorts for the change from baseline compared to a non-treated zone of Corneometer®
Time frame: At 1 month, 2 months, 3 months, 6 months and 9 months after the last injection session in both cohorts
Change from baseline of dermis hydration compared to a non-treated zone with Moisturemeter®
Comparison of both cohorts for the change from baseline compared to a non-treated zone of Moisturemeter®
Time frame: At 1 month, 2 months, 3 months, 6 months and 9 months after the last injection session in both cohorts
Change from baseline of skin oxidative stress compared to a non-treated zone
Comparison of both cohorts for Change from baseline of skin oxidative stress compared to a non-treated zone
Time frame: At 1 month, 2 months, 3 months and 6 months after the last injection session in both cohorts
For both cohorts combined, change from baseline of epidermis hydration of the treated zone, measured with Corneometer® and comparison to a non-treated zone
Time frame: 1 month after the first injection
For both cohorts combined, change from baseline of dermis hydration of the treated zone, measured with Moisturemeter D® and comparison to a non-treated zone
Time frame: 1 month after the first injection
Global aesthetic improvement with GAIS (Global Aesthetic Improvement Scale)
Clinical evaluation of global aesthetic improvement of the treated area with GAIS (Global Aesthetic Improvement Scale) evaluated by the investigator. Comparison to a non-treated zone.
Time frame: 7 days, 1 month, 2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only) after each injection session.
Pain felt by the subject using a subjective evaluation questionnaire
Evaluation of pain felt by the subject using a subjective evaluation questionnaire on skin improvement of the treated area.
Time frame: Immediately after the injection session.
Subject satisfaction using a subjective evaluation questionnaire
Evaluation of subject satisfaction using a subjective evaluation questionnaire on skin improvement of the treated area.
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only)
Difference in Global aesthetic improvement with GAIS (Global Aesthetic Improvement Scale) between Cohorts 1 and 2
Comparison of percentage of subjects with an improvement of the GAIS (Global Aesthetic Improvement Scale) of the treated area, evaluated by the investigator between cohort 1 and 2
Time frame: At 1 month, 2 months, 3 months and 6 months after the last injection session in both cohorts
Difference in subject satisfaction between Cohorts 1 and 2.
Comparison of percentage of satisfied subjects using a subjective evaluation questionnaire on skin improvement of the treated area between cohort 1 and 2
Time frame: At 1 month, 2 months, 3 months and 6 months after the last injection session in both cohorts
Appreciation of the injection quality using a subjective evaluation questionnaire
Evaluation of the appreciation of the injection quality using a subjective evaluation questionnaire completed by the injectors
Time frame: Immediately after the injection sessions
Evaluation of injection site reactions (investigator)
Percentage of injection site reactions recorded by the investigator
Time frame: 7 days, 1 month, 2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only)
Evaluation of injection site reactions (subject)
Evaluation of the duration and severity of the injection site reactions by the subject recorded in a diary.
Time frame: During 30 days after each injection session.
Product safety
Collection of adverse events and concomitant treatments
Time frame: Through study completion, up to 12 months
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