Evaluation of Performance and Safety of KIO015 in Face Skin Hydration Improvement

Skin Quality Clinical Trial

— PLUM  

Official title:

A Randomized, Controlled, Split-Face Study to Evaluate the Clinical Performance and Safety of KIO015 for Improving Face Skin Hydration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05747690
• Other study ID #: 20E1676-2/PLUM
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: April 4, 2024

Study information

• Verified date: October 2023
• Source: Kiomed Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The clinical investigation is designed to primarily confirm the performance of KIO015 in improving skin hydration after superficial intradermal injection. A non-treated zone (untreated hemi-face) will be used as comparator for exact evaluation of the zones between the treated and untreated ones The safety of KIO015 will also be evaluated for confirmation of initial data.

For this purpose, 80 healthy subjects will be injected in half of the face. In KIO015-PLUM, healthy subjects with signs of cutaneous aging and dehydrated skin on the face will receive 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 4, 2024
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

• Subject having resorbable filling product (e.g., hyaluronic acid) injections, a laser treatment, an ultrasound-based treatment a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to study start.

• Subjects having received botulinum toxin in the face within the 6 previous months.

• Subject having received mesotherapy products in the face within the 3 previous months.

• Subject having done a superficial or medium peeling or a superficial scrub on the face within the 2 previous months.

• Subject using cosmetic products with alpha hydroxy acids (AHA).

• Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand).

• Subject having received injections of permanent (e.g., acrylate polymers, silicone, polytetrafluoroethylene) or semi-permanent filling on the face.

• Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).

In terms of associated pathology

• Subject with ongoing and/or uncontrolled and/or recently recovered (<6 months) depression or psychiatric disorders or any other disorder that may pose a health risk to the subject in the study and/or may have an impact on the study assessments.

• Subject with severe, ongoing and uncontrolled diseases such as malignancy or history of malignancy, type I diabetes, liver failure, renal failure, lung/heart disease, neoplasia, malignant blood disease, tumor, HIV, or other major disease (e.g., systemic fungal infection).

• Subject with recurrent porphyria, coronary insufficiency, ventricular rhythm disorders, severe hypertension, obstructive cardiomyopathy, hyperthyroidism.

• Subject with any skin or systemic disease (acute and/or chronic), in the previous year, likely to interfere with the measured parameters or to put the subject to an undue risk.

• Subject with known history of or suffering from autoimmune disease and/or immune deficiency.

• Subject with current cutaneous inflammatory or infectious processes (e.g., acne, herpes, mycosis, papilloma, chronic eczema, atopic dermatitis …), abscess, unhealed wound, or a cancerous or precancerous lesion on the face.

• Subject with multiple allergies, anaphylactic shock history, evolutive allergic pathologies.

• Subject having history of allergy or hypersensitivity to one of the components of the tested device

• Subject having history of hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of amide type or one of the excipients of EMLA® 5% cream.

• Subject having history of hypersensitivity to chlorhexidine (or similar product) or one of the excipients of alcoholic chlorhexidine 0.5%.

• Subject predisposed to keloids or hypertrophic scarring.

• Subject with coagulation and/or homeostasis disorders.

• Subject with pigmentation disorders. Related to previous or ongoing treatment

• Subject under anti-coagulant treatment (such as aspirin, nonsteroidal anti-inflammatory drugs) or treatment liable to interfere with the healing process or hemostasis, during the previous month and during the study

• Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk.

• Subject undergoing a topical (on the face) or systemic treatment:

• anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study;

• immunosuppressors and/or corticoids during the 4 previous weeks and during the study;

• retinoids during the 6 previous months and during the study

Related Conditions & MeSH terms

• Skin Quality

Intervention

Device:
• KIO015
Innovative carboxymethyl chitosan-based biomaterial intended for intradermal injection

Locations

Country	Name	City	State
France	Eurofins Dermscan Pharmascan	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Kiomed Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Needle size	Comparison of the two sub-groups using different needles (30G and 32G)	1 month, 2 months, 3 months, 6 months and 9 months
Primary	Change from baseline of epidermis hydration with Corneometer®	For each cohort, comparison of the change from baseline of epidermis hydration measured with corneometer on the treated area at 1 month after the last intradermal injection session (M1 for cohort 1 and M3 for cohort 2), between the treated zone and the non-treated zone.	1 month after the last injection session
Secondary	Change from baseline of epidermis hydration with Corneometer®	For each cohort, change from baseline of epidermis hydration of the treated zone measured with Corneometer®	2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only) after each injection session.
Secondary	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®	2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only) after each injection session.
Secondary	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.	7 days (cohort 1 only), 1 month, 3 months and 6 months after each injection session.
Secondary	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®	At 1 month, 2 months, 3 months, 6 months and 9 months after the last injection session in both cohorts
Secondary	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®	At 1 month, 2 months, 3 months, 6 months and 9 months after the last injection session in both cohorts
Secondary	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	At 1 month, 2 months, 3 months and 6 months after the last injection session in both cohorts
Secondary	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
Secondary	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
Secondary	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.	7 days, 1 month, 2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only) after each injection session.
Secondary	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.	Immediately after the injection session.
Secondary	Subject satisfaction using a subjective evaluation questionnaire	Evaluation of subject satisfaction using a subjective evaluation questionnaire on skin improvement of the treated area.	1 month, 2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only)
Secondary	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 he treated area, evaluated by the investigator between cohort 1 and 2	At 1 month, 2 months, 3 months and 6 months after the last injection session in both cohorts
Secondary	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	At 1 month, 2 months, 3 months and 6 months after the last injection session in both cohorts
Secondary	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	Immediately after the injection sessions
Secondary	Evaluation of injection site reactions (investigator)	Percentage of injection site reactions recorded by the investigator	7 days, 1 month, 2 months, 3 months, 6 months, 9 months and 12 months (cohort 1 only)
Secondary	Evaluation of injection site reactions (subject)	Evaluation of the duration and severity of the injection site reactions by the subject recorded in a diary.	During 30 days after each injection session.
Secondary	Product safety	Collection of adverse events and concomitant treatments	Through study completion, up to 12 months