Skin QualityPLUMNCT05747690
Evaluation of Performance and Safety of KIO015 in Face Tissue Filling
A study testing KIO015 in people with Skin Quality, run by Kiomed Pharma at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Quality
- What is being tested?
- KIO015
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2023to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- KIO015
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIO015Device
Innovative carboxymethyl chitosan-based biomaterial intended for intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| KIO015 - Cohort 1 | Experimental | One injection of KIO015 on the hemi-face. The untreated hemi-face is used as a comparator. Receives: 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. Receives: Device: KIO015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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®
Measured: 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®
Measured: 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.
Measured: 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®
Measured: 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®
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately after the injection sessions
Evaluation of injection site reactions (investigator)
Percentage of injection site reactions recorded by the investigator
Measured: 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.
Measured: During 30 days after each injection session.
Product safety
Collection of adverse events and concomitant treatments
Measured: Through study completion, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start30 Jan 2023
- Primary completion4 May 2023
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiomed Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia MOREL-MANDRINO, MD, Principal investigator, Eurofins Dermscan Pharmascan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747690
- Sponsor's protocol ID
- 20E1676-2/PLUM
- Acronym
- PLUM
- Status last verified
- Sep 2025
- First submitted
- 16 Jan 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05747690
- Acronym / sponsor ID
- PLUM / 20E1676-2/PLUM
- Conditions
- Skin Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Kiomed PharmaIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KIO015 - Cohort 1 | Experimental | Device: KIO015One injection of KIO015 on the hemi-face. The untreated hemi-face is used as a comparator. |
| KIO015 - Cohort 2 | Experimental | Device: KIO0153 injections at one month interval on the hemi-face. The untreated hemi-face is used as a comparator. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (38 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIO015Innovative carboxymethyl chitosan-based biomaterial intended for intradermal injection | Device | KIO015 - Cohort 1, KIO015 - Cohort 2 |
Primary outcome
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.
18 secondary outcomes
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®
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®
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
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®
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®
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
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)
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
Time frame: Immediately after the injection session.
Subject satisfaction using a subjective evaluation questionnaire
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
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.
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
Time frame: Immediately after the injection sessions
Evaluation of injection site reactions (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)
Time frame: During 30 days after each injection session.
Product safety
Time frame: Through study completion, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia MOREL-MANDRINO, MD principal investigator
Eurofins Dermscan Pharmascan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KIO015 in people with Skin Quality, run by Kiomed Pharma at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global aesthetic improvement with GAIS (Global Aesthetic Improvement Scale) (time frame: 1 month after the first intradermal injection for both cohorts.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.