NCT07793149

Brief Summary

This study compared the efficacy and tolerability of two non-invasive facial treatment systems for improving 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 using 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, and before the second and third treatments, with the measurement before the third treatment defined as the primary endpoint. Additional exploratory assessments included multispectral skin imaging, participant-reported treatment experience and preference, and a Day-21 follow-up. The study aimed to determine whether enhanced epidermal preparation using hydroabrasion combined with lower-pressure jet infusion could achieve hydration outcomes comparable to those obtained with a conventional higher-pressure jet system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2026

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 25, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

August 25, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Skin HydrationHydroabrasionJet InfusionCorneometryTopical DeliveryFacial RejuvenationCosmetic Jet PressureEpidermal Preparation

Outcome Measures

Primary Outcomes (1)

  • Change in Facial Skin Hydration From Baseline to T3

    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 T3, measured before the third treatment session. The within-participant difference in change between the two facial sides was used for the primary comparison.

    Baseline (T0) to before the third treatment session (T3; approximately 14 days)

Study Arms (2)

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.

Device: Hydroabrasion and Jet Infusion

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.

Device: High-Pressure Jet Infusion

Interventions

Vacuum-assisted hydroabrasion was used for epidermal preparation, followed by jet infusion at 5 bar. The intervention was applied to the left facial side during three treatment sessions.

Arm 1: KIRA Treatment - Left Facial Side

Jet-based treatment and infusion at 6.89 bar was applied to the right facial side during three treatment sessions.

Arm 2: JET PEEL Treatment - Right Facial Side

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laser Center Be You, Be You Technology d.o.o.

Belgrade, 11000, Serbia

Location

Mella Cosmetics Doo Beograd

Belgrade, 11000, Serbia

Location

Study Officials

  • Katarina Obradovic

    Faculty of Pharmacy Novi Sad, University Business Academy in Novi Sad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors performing the instrumental skin measurements were independent from the treatment procedure and were unaware whether participants had undergone treatment and which intervention had been applied to each side of the face.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 28, 2026

Study Start

May 18, 2026

Primary Completion

June 22, 2026

Study Completion

July 14, 2026

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations