Trial Outcomes & Findings for Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh (NCT NCT01428024)

Results Overview

To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

At week 8 - change of lips from baseline

Results posted on

2022-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Restylane LipVolume Open label Restylane Lip Volume : Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.	Restylane Lip Refresh Open label Restylane Lip Refresh : Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
Overall Study STARTED	30	30
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restylane LipVolume n=30 Participants Open label Restylane Lip Volume : Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and week 12.	Restylane Lip Refresh n=30 Participants Open label Restylane Lip Refresh : Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and week 12.	Total n=60 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	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.1 years STANDARD_DEVIATION 12.5 • n=5 Participants	49.4 years STANDARD_DEVIATION 6.4 • n=7 Participants	42.8 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Sweden	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: At week 8 - change of lips from baseline

Population: One subject did not perform GEIS evaluation at the 8-week visit and withdrew consent after the visit

To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.

Outcome measures

Outcome measures
Measure	Restylane Lip Volume n=29 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip.	Restylane Lip Refresh n=30 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip.
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment	86.2 percentage improved subjects Interval 68.3 to 96.1	86.7 percentage improved subjects Interval 69.3 to 96.2

SECONDARY outcome

Timeframe: week 36 - change from baseline

Population: Restylane Lip Volume: One subject withdrew consent after the 8-week visit and thus did not perform the GEIS evaluation at 36 weeks. Restylane Lip Refresh: Two subjects did not perform the GEIS evaluation at 36 weeks.

To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS at week 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.

Outcome measures

Outcome measures
Measure	Restylane Lip Volume n=29 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip.	Restylane Lip Refresh n=28 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip.
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment	93.1 percentage improved subjects Interval 77.2 to 99.2	78.6 percentage improved subjects Interval 59.0 to 91.7

SECONDARY outcome

Timeframe: week 36 - change from baseline

To evaluate esthetic change of lips from baseline as judged by the treating investigator using GEIS at week 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change.

Outcome measures

Outcome measures
Measure	Restylane Lip Volume n=29 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip.	Restylane Lip Refresh n=29 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip.
GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment	82.8 percentage improved subjects Interval 64.2 to 94.2	82.8 percentage improved subjects Interval 64.2 to 94.2

SECONDARY outcome

Timeframe: week 36 - change from baseline

To evaluate esthetic change of lips from baseline as judged by the independent evaluator using GEIS at week 2, 4, 12, 26 and 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.

Outcome measures

Outcome measures
Measure	Restylane Lip Volume n=29 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip.	Restylane Lip Refresh n=29 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip.
GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment	86.2 percentage improved subjects Interval 68.3 to 96.1	86.2 percentage improved subjects Interval 68.3 to 96.1

SECONDARY outcome

Timeframe: week 8 - change from baseline

To evaluate the efficacy in terms of Medicis Lip Fullness Scale (MLFS) score by live assessment performed separately by the treating and the independent investigators in the Restylane Lip Volume group. The scale has five levels: Very thin, thin, median, full, very full. Treatment success is defined as at least one grade increase.

Outcome measures

Outcome measures
Measure	Restylane Lip Volume n=30 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip.	Restylane Lip Refresh GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip.
MLFS (Medicis Lip Fullness Scale) at Week 8	50.0 percentage improved subjects Interval 31.3 to 68.7	—

SECONDARY outcome

Timeframe: Week 8

To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire at week 8 after treatment. The subject satisfaction questionnaire consists of questions regarding the looks, appearance, disomfort, and satisfaction regarding the treatment of the lips. The question that will be referred to is: How satisfied are you today with (the look of) your lips ?

Outcome measures

Outcome measures
Measure	Restylane Lip Volume n=29 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip.	Restylane Lip Refresh n=30 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip.
Subject Satisfaction Questionnaire	93 percentage satisfied subjects	87 percentage satisfied subjects

SECONDARY outcome

Timeframe: 2 weeks after initial treatment

To evaluate the acute safety profile (bruising, itching, pain, redness, swelling and tenderness) in terms of a 14-day subject diary after initial treatment. Subjects still reporting one or more of the symptoms; bruising, itching, pain, redness, swelling and tenderness in the diary at day 14.

Outcome measures

Outcome measures
Measure	Restylane Lip Volume n=30 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Volume (a Hyaluronic acid gel)with maximum 1.5 ml for each upper/lower lip.	Restylane Lip Refresh n=30 Participants GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip.
Subject Diary for 14 Days After Initial Treatment	2 participants	6 participants

Adverse Events

Restylane LipVolume

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Restylane Lip Refresh

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Restylane LipVolume n=30 participants at risk Open label Restylane Lip Volume : Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.	Restylane Lip Refresh n=30 participants at risk Open label Restylane Lip Refresh : Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
Musculoskeletal and connective tissue disorders Knee joint injury	3.3% 1/30 • Number of events 1	0.00% 0/30
Infections and infestations Viral encephalitis	3.3% 1/30 • Number of events 1	0.00% 0/30
Hepatobiliary disorders Cholecystitis	3.3% 1/30 • Number of events 1	0.00% 0/30
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Worsening of benign neoplasm	3.3% 1/30 • Number of events 1	0.00% 0/30

Other adverse events

Other adverse events
Measure	Restylane LipVolume n=30 participants at risk Open label Restylane Lip Volume : Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.	Restylane Lip Refresh n=30 participants at risk Open label Restylane Lip Refresh : Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
Gastrointestinal disorders Lip dry	6.7% 2/30 • Number of events 4	3.3% 1/30 • Number of events 1
General disorders Implant site haematoma	16.7% 5/30 • Number of events 9	30.0% 9/30 • Number of events 12
General disorders Implant site mass	23.3% 7/30 • Number of events 10	23.3% 7/30 • Number of events 8
General disorders Implant site pain	6.7% 2/30 • Number of events 3	0.00% 0/30
General disorders Implant site swelling	6.7% 2/30 • Number of events 4	23.3% 7/30 • Number of events 10
General disorders Injection site pain	10.0% 3/30 • Number of events 4	3.3% 1/30 • Number of events 1
Infections and infestations oral herpes	3.3% 1/30 • Number of events 1	6.7% 2/30 • Number of events 2
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/30	6.7% 2/30 • Number of events 2
General disorders Implant site erythema	0.00% 0/30	6.7% 2/30 • Number of events 2
General disorders Implant site haemorrhage	3.3% 1/30 • Number of events 1	10.0% 3/30 • Number of events 8

Additional Information

Head of Medical Affairs

Q-Med AB

Phone: + 46 (0) 18 4749000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60