Evaluation of Performance and Safety of KIO015 in Face Tissue Filling

NCT05747690 | Completed

• 1 other identifier: 20E1676-2/PLUM
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Quality

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month after the first intradermal injection for both cohorts.

Secondary Outcomes (18)

• 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.

• 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

Other Outcomes (1)

• Needle size

  1 month, 2 months, 3 months, 6 months and 9 months

Study Arms (2)

KIO015 - Cohort 1

EXPERIMENTAL

One injection of KIO015 on the hemi-face. The untreated hemi-face is used as a comparator.

Device: KIO015

KIO015 - Cohort 2

EXPERIMENTAL

3 injections at one month interval on the hemi-face. The untreated hemi-face is used as a comparator.

Device: KIO015

Interventions

KIO015 DEVICE

Innovative carboxymethyl chitosan-based biomaterial intended for intradermal injection

KIO015 - Cohort 1; KIO015 - Cohort 2

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• Kiomed Pharma: lead

Study Sites (1)

Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

Location

Study Officials

• Patricia MOREL-MANDRINO, MD

  Eurofins Dermscan Pharmascan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 28, 2023
• Study Start: January 30, 2023
• Primary Completion: May 4, 2023
• Study Completion: May 2, 2024
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)