Facial Skin HydrationNCT07793149
Comparison of KIRA Hydrating Treatment and Jet Peel for Facial Skin Hydration
A study testing Vacuum-Assisted Hydroabrasion, High-Pressure Jet Infusion and Jet Infusion at 5 Bar in people with Facial Skin Hydration and Skin Rejuvenation, run by Faculty of Pharmacy Novi Sad at 2 sites in Serbia.
Trial summary
This study compared the effects and tolerability of two non-invasive facial treatment systems on skin hydration: a hydroabrasion-jet system (KIRA) and a conventional high-pressure jet system (JET PEEL). Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Facial Skin Hydration, Skin Rejuvenation
- What is being tested?
- Vacuum-Assisted Hydroabrasion, High-Pressure Jet Infusion and Jet Infusion at 5 Bar
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesSerbia
- Study dates
- 18 May 2026to 14 Jul 2026
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants aged 30-65 years
- Fitzpatrick skin types II-III
- Presence of signs of facial skin aging, including one or more of the following: hyperkeratosis, hyperpigmentation, facial or age-related wrinkles, and enlarged pores
- Generally healthy and without contraindications to the study procedures
- Willing and able to provide informed consent and participate in the study procedures
Who cannot join
- Pregnancy or breastfeeding
- Serious vascular disorders
- Pacemaker or metal implants in the treatment area
- Malignant skin disease
- Autoimmune or endocrine disease, diabetes, or acquired immunodeficiency syndrome
- Psoriasis, herpes, or other active skin disease
Show all 13Show fewer
- Infection in the treatment area
- Tendency toward keloid scarring or allergic reactions
- Long-term corticosteroid therapy or other medication considered incompatible with the procedures
- Hyaluronic acid filler or botulinum toxin injections in the treatment area
- Tattoo or permanent makeup in the treatment area
- Invasive aesthetic procedures within the previous 5 months
- Failure to meet the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Serbia2 sites
Laser Center Be You, Be You Technology d.o.o.
Belgrade, 11000
Mella Cosmetics Doo Beograd
Belgrade, 11000
About this study
Official title: Split-Face Comparison of Vacuum Hydroabrasion-Jet System Versus Conventional High-Pressure Jet Peel System for Facial Rejuvenation
This study compared the effects and tolerability of two non-invasive facial treatment systems on skin hydration: a hydroabrasion-jet system (KIRA) and a conventional high-pressure jet system (JET PEEL). Twenty-three women aged 30-65 years underwent three treatment sessions in an intraindividual split-face design, with KIRA applied to the left side of the face and JET PEEL to the right side. Skin hydration was assessed by corneometry at baseline, 48 hours after the first treatment, before the second treatment, and before the third treatment; the measurement before the third treatment was the primary endpoint. Additional exploratory assessments included multispectral skin imaging, participant-reported treatment experience and preference, and a 21-day follow-up. The study evaluated differences in hydration outcomes between a protocol combining vacuum-assisted hydroabrasion with 5-bar jet infusion and a conventional high-pressure jet treatment at 6.89 bar.
- Conditions
- Facial Skin Hydration, Skin Rejuvenation
- Being tested
- Vacuum-Assisted Hydroabrasion, High-Pressure Jet Infusion, Jet Infusion at 5 Bar
- Keywords
- Skin Hydration, Hydroabrasion, Jet Infusion, Corneometry, Topical Delivery, Facial Rejuvenation, Cosmetic Jet Pressure, Epidermal Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum-Assisted HydroabrasionDevice
Vacuum-assisted hydroabrasion was used for epidermal preparation. The intervention was applied to the left facial side during three treatment sessions.
High-Pressure Jet InfusionDevice
Jet-based treatment and infusion at 6.89 bar was applied to the right facial side during three treatment sessions.
Jet Infusion at 5 BarDevice
Jet infusion at 5 bar was applied to the left facial side following vacuum-assisted hydroabrasion during each of the three treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: KIRA Treatment - Left Facial Side | Experimental | Participants received treatment with the KIRA hydroabrasion-jet system on the left facial side. The protocol consisted of vacuum-assisted hydroabrasion for epidermal preparation followed by 5-bar jet infusion. Three treatment sessions were performed according to the study protocol. Receives: Device: Vacuum-Assisted Hydroabrasion; Device: Jet Infusion at 5 Bar |
| Arm 2: JET PEEL Treatment - Right Facial Side | Active comparator | Participants received treatment with the JET PEEL system on the right facial side. The protocol consisted of jet-based treatment and infusion at 6.89 bar. Three treatment sessions were performed according to the study protocol. Receives: Device: High-Pressure Jet Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Facial Skin Hydration From Baseline to Before the Third Treatment Session
Facial skin hydration was measured separately on the KIRA-treated and JET PEEL-treated facial sides using corneometry. The primary outcome was the change in corneometer-measured skin hydration, expressed in arbitrary units (a.u.), from baseline (T0) to the measurement before the third treatment session (T3). The within-participant difference in change between the two facial sides was used for the primary comparison.
Measured: Baseline (T0) to before the third treatment session (T3; approximately 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start18 May 2026
- Primary completion22 Jun 2026
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Skin HydrationStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intraindividual split-face comparative study. Each participant received both interventions during the same treatment sessions: KIRA was applied to the left side of the face and JET PEEL to the right side. Outcomes were assessed separately for each facial side, allowing within-participant comparison of the two interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Pharmacy Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Obradović, Faculty of Pharmacy Novi Sad
- Investigators
- Katarina Obradovic, Principal investigator, Faculty of Pharmacy Novi Sad, University Business Academy in Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793149
- Sponsor's protocol ID
- FFNS-KIRA-JET-01
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study involves a small cohort and includes potentially identifiable clinical and facial imaging data. Aggregate and de-identified study results will be reported in the scientific publication.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-Face Comparison of Vacuum Hydroabrasion-Jet System Versus Conventional High-Pressure Jet Peel System for Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT07793149
- Acronym / sponsor ID
- FFNS-KIRA-JET-01
- Conditions
- Facial Skin Hydration, Skin Rejuvenation
- Keywords
- Skin Hydration, Hydroabrasion, Jet Infusion, Corneometry, Topical Delivery, Facial Rejuvenation, Cosmetic Jet Pressure, Epidermal Preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Faculty of Pharmacy Novi SadUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 28 Aug 2026 (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.
This study compared the effects and tolerability of two non-invasive facial treatment systems on skin hydration: a hydroabrasion-jet system (KIRA) and a conventional high-pressure jet system (JET PEEL). Twenty-three women aged 30-65 years underwent three treatment sessions in an intraindividual split-face design, with KIRA applied to the left side of the face and JET PEEL to the right side. Skin hydration was assessed by corneometry at baseline, 48 hours after the first treatment, before the second treatment, and before the third treatment; the measurement before the third treatment was the primary endpoint. Additional exploratory assessments included multispectral skin imaging, participant-reported treatment experience and preference, and a 21-day follow-up. The study evaluated differences in hydration outcomes between a protocol combining vacuum-assisted hydroabrasion with 5-bar jet infusion and a conventional high-pressure jet treatment at 6.89 bar.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intraindividual split-face comparative study. Each participant received both interventions during the same treatment sessions: KIRA was applied to the left side of the face and JET PEEL to the right side. Outcomes were assessed separately for each facial side, allowing within-participant comparison of the two interventions.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: KIRA Treatment - Left Facial Side | Experimental | Device: Vacuum-Assisted Hydroabrasion, Device: Jet Infusion at 5 BarParticipants received treatment with the KIRA hydroabrasion-jet system on the left facial side. The protocol consisted of vacuum-assisted hydroabrasion for epidermal preparation followed by 5-bar jet infusion. Three treatment sessions were performed according to the study protocol. |
| Arm 2: JET PEEL Treatment - Right Facial Side | Active comparator | Device: High-Pressure Jet InfusionParticipants received treatment with the JET PEEL system on the right facial side. The protocol consisted of jet-based treatment and infusion at 6.89 bar. Three treatment sessions were performed according to the study protocol. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participants aged 30-65 years
- Fitzpatrick skin types II-III
- Presence of signs of facial skin aging, including one or more of the following: hyperkeratosis, hyperpigmentation, facial or age-related wrinkles, and enlarged pores
- Generally healthy and without contraindications to the study procedures
- Willing and able to provide informed consent and participate in the study procedures
Key exclusion criteria (13 listed)
- Pregnancy or breastfeeding
- Serious vascular disorders
- Pacemaker or metal implants in the treatment area
- Malignant skin disease
- Autoimmune or endocrine disease, diabetes, or acquired immunodeficiency syndrome
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 |
|---|---|---|
| Vacuum-Assisted HydroabrasionVacuum-assisted hydroabrasion was used for epidermal preparation. The intervention was applied to the left facial side during three treatment sessions. | Device | Arm 1: KIRA Treatment - Left Facial Side |
| High-Pressure Jet InfusionJet-based treatment and infusion at 6.89 bar was applied to the right facial side during three treatment sessions. | Device | Arm 2: JET PEEL Treatment - Right Facial Side |
| Jet Infusion at 5 BarJet infusion at 5 bar was applied to the left facial side following vacuum-assisted hydroabrasion during each of the three treatment sessions. | Device | Arm 1: KIRA Treatment - Left Facial Side |
Primary outcome
Change in Facial Skin Hydration From Baseline to Before the Third Treatment Session
Time frame: Baseline (T0) to before the third treatment session (T3; approximately 14 days)
Facial skin hydration was measured separately on the KIRA-treated and JET PEEL-treated facial sides using corneometry. The primary outcome was the change in corneometer-measured skin hydration, expressed in arbitrary units (a.u.), from baseline (T0) to the measurement before the third treatment session (T3). The within-participant difference in change between the two facial sides was used for the primary comparison.
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 10 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the study involves a small cohort and includes potentially identifiable clinical and facial imaging data. Aggregate and de-identified study results will be reported in the scientific publication.
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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.
Katarina Obradovic principal investigator
Faculty of Pharmacy Novi Sad, University Business Academy in Novi Sad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum-Assisted Hydroabrasion, High-Pressure Jet Infusion and Jet Infusion at 5 Bar in people with Facial Skin Hydration and Skin Rejuvenation, run by Faculty of Pharmacy Novi Sad at 2 sites in Serbia.
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 5 inclusion and 13 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Serbia. 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?
Change in Facial Skin Hydration From Baseline to Before the Third Treatment Session (time frame: Baseline (T0) to before the third treatment session (T3; approximately 14 days)). 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 10 Sep 2026.