Trial Outcomes & Findings for Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour Deficiency (NCT NCT03097783)

NCT ID: NCT03097783

Last Updated: 2023-11-03

Results Overview

The primary objective is to demonstrate superiority of Perlane-Lido relative to no-treatment in the treatment of Midface volume Deficit and/or Midface Contour Deficiency by comparing the percent responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face, as measured by blinded evaluator at 6 months. Medicis Midface Volume Scale (MMVS) is a 4-grade scale assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 169 participants
• Primary outcome timeframe: 6 month
• Results posted on: 2023-11-03

Participant Flow

Participant milestones

Measure	Restylane Perlane Lidocaine Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface Restylane Perlane Lidocaine: Intradermal injection	No Intervention Arm No treatment
Overall Study STARTED	132	37
Overall Study COMPLETED	123	31
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour Deficiency

Baseline characteristics by cohort

Measure	Restylane Perlane Lidocaine n=132 Participants Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface Restylane Perlane Lidocaine: Intradermal injection	No Intervention Arm n=37 Participants No treatment	Total n=169 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	132 Participants n=5 Participants	36 Participants n=7 Participants	168 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 10.3 • n=5 Participants	48 years STANDARD_DEVIATION 11.1 • n=7 Participants	46 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	35 Participants n=7 Participants	154 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	2 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian	132 Participants n=5 Participants	37 Participants n=7 Participants	169 Participants n=5 Participants
Region of Enrollment China	132 participants n=5 Participants	37 participants n=7 Participants	169 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month

Population: All summaries will be done separately for Group A and B. For statistical inference,only Group B will be used.

The primary objective is to demonstrate superiority of Perlane-Lido relative to no-treatment in the treatment of Midface volume Deficit and/or Midface Contour Deficiency by comparing the percent responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face, as measured by blinded evaluator at 6 months.

Medicis Midface Volume Scale (MMVS) is a 4-grade scale assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits.

1. Fairly full midface

2. Mild loss of fullness in midface area

3. Moderate loss of fullness with slight hollowing below malar prominence

4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence

Outcome measures

Measure	Restylane Perlane Lidocaine n=110 Participants Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface Restylane Perlane Lidocaine: Intradermal injection	No Intervention Arm n=37 Participants No treatment
Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale	67 Participants	8 Participants

Adverse Events

Restylane Perlane Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Head of Development

Q-Med AB

Phone: +46184749000

Email: reception.seupp@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place