Trial Outcomes & Findings for Changing in Skin Physiology After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces (NCT NCT02312154)

Last Updated: 2015-04-03

Results Overview

We measured a hydration level by a corneometer device (Courage \& Khazaka, Cologne, Germany). The range of hydration level was 0 (as dry as possible) \~120 AU (Arbitrary Unit)(most moist possible)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

12 weeks

Results posted on

2015-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Restylane Vital stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Changing in Skin Physiology After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restylane Vital n=25 Participants stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Age, Continuous	37 years STANDARD_DEVIATION 8 • n=99 Participants
Age, Customized 20-29 years	4 participants n=99 Participants
Age, Customized 30-39 years	14 participants n=99 Participants
Age, Customized 40-49 years	5 participants n=99 Participants
Age, Customized 50-59 years	2 participants n=99 Participants
Sex: Female, Male Female	18 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Region of Enrollment Korea, Republic of	25 participants n=99 Participants
hydration treated side	45.47 AU (Arbitrary Unit) STANDARD_DEVIATION 10.53 • n=99 Participants
hydration untreated side	46.21 AU (Arbitrary Unit) STANDARD_DEVIATION 11.35 • n=99 Participants
elasticity treated side	294.32 AU (arbitrary unit) STANDARD_DEVIATION 90.25 • n=99 Participants
elasticity untreated side	272.70 AU (arbitrary unit) STANDARD_DEVIATION 96.89 • n=99 Participants
melanin index treated side	133.97 AU(arbitrary unit) STANDARD_DEVIATION 25.56 • n=99 Participants
melanin index untreated side	133.66 AU(arbitrary unit) STANDARD_DEVIATION 27.68 • n=99 Participants
erythema index treated side	292.74 AU(arbitrary unit) STANDARD_DEVIATION 71.64 • n=99 Participants
erythema index untreated side	290.50 AU(arbitrary unit) STANDARD_DEVIATION 59.35 • n=99 Participants

PRIMARY outcome

Timeframe: 12 weeks

We measured a hydration level by a corneometer device (Courage \& Khazaka, Cologne, Germany). The range of hydration level was 0 (as dry as possible) \~120 AU (Arbitrary Unit)(most moist possible)

Outcome measures

Outcome measures
Measure	Treated Side (Restylane Vital) n=24 Participants stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin	Untreated Side n=24 Participants Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
Hydration Level	53.19 AU (arbitrary unit) Standard Deviation 9.08	46.75 AU (arbitrary unit) Standard Deviation 9.24

PRIMARY outcome

Timeframe: 12 weeks

We measured a elasticity by a reviscometer device (Courage \& Khazaka, Cologne, Germany). The range of elasticity was 0 (most elastic possible as) \~400 AU(Arbitrary Unit) (inelastic as possible)

Outcome measures

Outcome measures
Measure	Treated Side (Restylane Vital) n=24 Participants stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin	Untreated Side n=24 Participants Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
Elasticity	242.33 AU (arbitrary unit) Standard Deviation 72.21	271.15 AU (arbitrary unit) Standard Deviation 86.10

PRIMARY outcome

Timeframe: 12 weeks

We measured a melanin index by a mexameter device (Courage \& Khazaka, Cologne, Germany). The range of melanin index was 0 (as bright as possible) \~999 AU (Arbitrary Unit) (most dark possible).

Outcome measures

Outcome measures
Measure	Treated Side (Restylane Vital) n=24 Participants stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin	Untreated Side n=24 Participants Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
Melanin Index	147.25 AU (arbitrary unit) Standard Deviation 27.46	149.00 AU (arbitrary unit) Standard Deviation 26.86

PRIMARY outcome

Timeframe: 12 weeks

We measured an erythema index by a mexameter device (Courage \& Khazaka, Cologne, Germany). The range of erythema index is 0\~999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) \~999 AU (most erythematous possible)

Outcome measures

Outcome measures
Measure	Treated Side (Restylane Vital) n=24 Participants stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin	Untreated Side n=24 Participants Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
Erythema Index	253.66 AU (arbitrary unit) Standard Deviation 58.19	243.53 AU (arbitrary unit) Standard Deviation 51.65

PRIMARY outcome

Timeframe: 12 weeks

The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse.

Outcome measures

Outcome measures
Measure	Treated Side (Restylane Vital) n=24 Participants stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin	Untreated Side n=24 Participants Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
Global Aesthetic Improvement Scale (Investigator)	1.38 scores on a scale Standard Deviation 0.77	0 scores on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 12 weeks

The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse

Outcome measures

Outcome measures
Measure	Treated Side (Restylane Vital) n=24 Participants stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin	Untreated Side n=24 Participants Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
Global Aesthetic Improvement Scale (Subject)	1.33 scores on a scale Standard Deviation 1.05	0 scores on a scale Standard Deviation 0

Adverse Events

Restylane Vital

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Restylane Vital n=24 participants at risk stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Skin and subcutaneous tissue disorders erythema	100.0% 24/24 • Number of events 24 • 12weeks Adverse events were self-reported by the patients completing a questionnaire.

Additional Information

Yang Won Lee

Konkuk University

Phone: 8220305172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place