New skin injection shows promise for hydration
NCT ID NCT05747690
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a new injectable gel called KIO015 in 78 healthy adults with dehydrated, aging skin. Each person received injections on one side of the face, while the other side was left untreated for comparison. The goal was to see if KIO015 improves skin hydration and overall appearance safely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KIO015 (a carboxymethyl chitosan-based biomaterial injected into the skin)
- What this could lead to
- If successful, KIO015 could become a new option for improving skin hydration and reducing signs of aging without surgery.
- What could go wrong
- This is a small, early-stage study with no control group for the whole face. The main outcome is subjective (doctor's rating), and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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78 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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May 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Eurofins Dermscan Pharmascan
Villeurbanne, 69100, France
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