Trial Outcomes & Findings for Safety and Efficacy of Restylane Vital for Skin Rejuvenation of Dorsal Hands (NCT NCT02545608)

NCT ID: NCT02545608

Last Updated: 2022-08-26

Results Overview

Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 109 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2022-08-26

Participant Flow

Participant milestones

Measure	Restylane Vital in Both Hands	Restylane Vital in Randomized Hand, no Treatment in the Other
Overall Study STARTED	9	100
Overall Study COMPLETED	9	93
Overall Study NOT COMPLETED	0	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Restylane Vital for Skin Rejuvenation of Dorsal Hands

Baseline characteristics by cohort

Measure	Restylane Vital in Both Hands n=9 Participants	Restylane Vital in Randomized Hand, no Treatment in the Other n=100 Participants	Total n=109 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	9 Participants n=5 Participants	92 Participants n=7 Participants	101 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	42.2 years STANDARD_DEVIATION 8.2 • n=5 Participants	48.5 years STANDARD_DEVIATION 11.2 • n=7 Participants	48 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	96 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment China	9 participants n=5 Participants	100 participants n=7 Participants	109 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The 9 subjects treated with Restylane Vital in both hands not included

Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome.

Outcome measures

Measure	Restylane Vital in Randomized Hand n=100 Participants Restylane Vital in randomized hand	No-treatment Control Hand n=100 Participants No treatment control hand
The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.	0.85 units on a scale Standard Deviation 0.59	2.17 units on a scale Standard Deviation 0.49

Adverse Events

Restylane Vital in Both Hands

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Restylane Vital in Randomized Hand

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

No-treatment Control Hand

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Restylane Vital in Both Hands n=9 participants at risk Restylane Vital in both hands	Restylane Vital in Randomized Hand n=100 participants at risk Restylane Vital in randomized hand	No-treatment Control Hand n=100 participants at risk No treatment control hand
Gastrointestinal disorders Chronic gastritis	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
Musculoskeletal and connective tissue disorders Worsening of lumbar disc protrusion	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.

Other adverse events

Measure	Restylane Vital in Both Hands n=9 participants at risk Restylane Vital in both hands	Restylane Vital in Randomized Hand n=100 participants at risk Restylane Vital in randomized hand	No-treatment Control Hand n=100 participants at risk No treatment control hand
General disorders Implant site erythema	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	0.00% 0/100 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
General disorders Implant site pruritus	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	2.0% 2/100 • Number of events 2 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	0.00% 0/100 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
General disorders Injection site discolouration	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	4.0% 4/100 • Number of events 4 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	0.00% 0/100 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
General disorders Injection site erythema	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	0.00% 0/100 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
General disorders Injection site nodule	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
General disorders Injection site pain	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	4.0% 4/100 • Number of events 4 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	0.00% 0/100 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
General disorders Injection site pruritus	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	2.0% 2/100 • Number of events 2 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	0.00% 0/100 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
General disorders Injection site swelling	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	4.0% 4/100 • Number of events 4 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	2.0% 2/100 • Number of events 2 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
Skin and subcutaneous tissue disorders Folliculitis	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	0.00% 0/100 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 2 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	0.00% 0/100 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	0.00% 0/100 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.
Vascular disorders Phlebitis	0.00% 0/9 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	1.0% 1/100 • Number of events 1 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.	0.00% 0/100 • 1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.) Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, or spontaneous reports from the subjects.

Additional Information

Head of Development

Q-Med AB

Phone: + 46 (0) 18 474 90 00

Email: reception.seupp@galderma.com

Results disclosure agreements

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

Restriction type: OTHER