A Randomized, Controlled, Split-Face Study to Evaluate the Clinical Performance and Safety of Intradermal Injection of KIO015 for Tissue Filling in Subjects With Signs of Cutaneous Dehydration on the Face

Kiomed Pharma1 site in 1 country78 target enrollmentJanuary 30, 2023

ConditionsSkin Quality

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Quality
Sponsor: Kiomed Pharma
Enrollment: 78
Locations: 1
Primary Endpoint: Global aesthetic improvement with GAIS (Global Aesthetic Improvement Scale)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 30, 2023

End Date

May 2, 2024

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kiomed Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject with signs of cutaneous ageing on the face according to investigator's judgment.
•Subject with dehydrated skin on the face (value \< 60 A.U with Corneometer®).
•Subject having given freely and expressly his informed consent.
•Subject, psychologically able to understand the study related information and to give a written informed consent.
•Subject affiliated to a health social security system.
•Female of childbearing potential must use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study.
•Female subjects of childbearing potential must have a negative pregnancy test at the inclusion.

Exclusion Criteria

•In terms of population
•Pregnant or nursing woman or planning a pregnancy during the study.
•Woman with menopause from less than 1 year or in perimenopause, without hormonal treatment.
•Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
•Subject in a social or sanitary establishment.
•Subject participating to another research on human beings or being in an exclusion period for a previous study.
•Subject having received 4500 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present study.
•Subject suffering from dysmorphophobia or having an unreasonable expectation about the treatment results.
•Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
•Subject with a tattoo, a scar, moles or too many hairs or anything on the face which may interfere with the study at the investigator appreciation.

Outcomes

Primary Outcomes

Global aesthetic improvement with GAIS (Global Aesthetic Improvement Scale)

Time Frame: 1 month after the first intradermal injection for both cohorts.

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.

Secondary Outcomes

For both cohorts combined, evaluation of cutaneous hydration in a sub-group of subjects not using hydrating agent(1 month after the first intradermal injection)
Change from baseline of epidermis hydration with Corneometer®(1 month, 2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only) after each injection session.)
For both cohorts combined, change from baseline of epidermis hydration of the treated zone, measured with Corneometer® and comparison to a non-treated zone(1 month after the first injection)
Change from baseline of dermis hydration with Moisturemeter D®(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(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®(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®(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(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 dermis hydration of the treated zone, measured with Moisturemeter D® and comparison to a non-treated zone(1 month after the first injection)
Global aesthetic improvement with GAIS (Global Aesthetic Improvement Scale)(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(Immediately after the injection session.)
Subject satisfaction using a subjective evaluation questionnaire(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(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.(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(Immediately after the injection sessions)
Evaluation of injection site reactions (investigator)(7 days, 1 month, 2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only))
Evaluation of injection site reactions (subject)(During 30 days after each injection session.)
Product safety(Through study completion, up to 12 months)