Trial Outcomes & Findings for Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds (NCT NCT03319719)

NCT ID: NCT03319719

Last Updated: 2019-10-01

Results Overview

Pain was assessed using a using a 10 centimeter (cm) VAS. It included 21-numbered circles at 0.5 cm increments, spanning 10 cm total, and was anchored by word descriptors. The VAS scores ranged from 0 (no pain) to 10 (very severe pain).The level of pain was evaluated for each NLF independently immediately upon completion of injection (time zero) on Day 1.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

Day 1

Results posted on

2019-10-01

Participant Flow

The study was conducted at 3 investigative sites in the United States.

A total of 65 participants were screened, out of which 52 participants were randomized and treated. Of these, 51 participants completed the study.

Participant milestones

Participant milestones
Measure	Belotero Balance With or Without Lidocaine Participants received treatment with Test Product belotero balance with lidocaine (BBL), injection, in one of the two nasolabial fold (NLF) and Control Product belotero balance (BB) without lidocaine, injection, in the contralateral NLF on Day 1. The BBL and BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 milliliter (mL) per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL and BB injections on Week 2.
Overall Study STARTED	52
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Belotero Balance With or Without Lidocaine Participants received treatment with Test Product belotero balance with lidocaine (BBL), injection, in one of the two nasolabial fold (NLF) and Control Product belotero balance (BB) without lidocaine, injection, in the contralateral NLF on Day 1. The BBL and BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 milliliter (mL) per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL and BB injections on Week 2.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belotero Balance With or Without Lidocaine n=52 Participants Participants received treatment with Test Product BBL, injection, in one of the two NLF and Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BBL and BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL and BB injections on Week 2.
Age, Continuous	58.4 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic and not Latino	51 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	16 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	36 Participants n=5 Participants
Region of Enrollment United States	52 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type I	1 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type II	20 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type III	15 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type IV	4 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type V	5 Participants n=5 Participants
Fitzpatrick Skin Type Skin Type VI	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: The full analysis set (FAS) included all randomized participants and were analyzed as randomized.

Outcome measures

Outcome measures
Measure	Test Product: BBL n=52 Participants Participants received treatment with Test Product BBL, injection, in one of the two NLF on Day 1. The BBL injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL injection on Week 2.	Control Product: BB n=52 Participants Participants received treatment with Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BB injection on Week 2.
Mean Pain Using Visual Analog Scale (VAS)	3.07 score on a scale Standard Deviation 1.88	5.94 score on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: Week 6

Population: The FAS included all randomized participants and was analyzed as randomized. Participants who were evaluable for this measure at given time period were included.

The Merz NLF scale was used to measure the aesthetic effectiveness of the study products. Each NLF was assessed separately. The Merz NLF scale is a 5-grade scale ranging from 0 (no folds) to 4 (very severe folds). Response was defined \>=1-point improvement on the Merz NLF Scale for each NLF compared to baseline.

Outcome measures

Outcome measures
Measure	Test Product: BBL n=51 Participants Participants received treatment with Test Product BBL, injection, in one of the two NLF on Day 1. The BBL injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL injection on Week 2.	Control Product: BB n=51 Participants Participants received treatment with Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BB injection on Week 2.
Percentage of Responders With Greater Than or Equal to (>=) 1-point Improvement as Evaluated Using Merz NLF Scale at Week 6	51.0 percentage of participants	52.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 6

Population: The SES included all participants who were enrolled into the study, randomized, and received an injection.

Outcome measures

Outcome measures
Measure	Test Product: BBL n=52 Participants Participants received treatment with Test Product BBL, injection, in one of the two NLF on Day 1. The BBL injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL injection on Week 2.	Control Product: BB Participants received treatment with Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BB injection on Week 2.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	5 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	0 participants	—

SECONDARY outcome

Timeframe: Baseline up to Week 6

Population: The SES included all participants who were enrolled into the study, randomized, and received an injection.

CTR were evaluated using participant diaries. Participants recorded daily in the diary any pre-defined CTR that occurred. These CTR included swelling, firmness, lumps/bumps, bruising, pain, tenderness upon pressing, redness, discoloration (not redness or bruising), itching, stinging/burning, and numbness.

Outcome measures

Outcome measures
Measure	Test Product: BBL n=52 Participants Participants received treatment with Test Product BBL, injection, in one of the two NLF on Day 1. The BBL injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL injection on Week 2.	Control Product: BB n=52 Participants Participants received treatment with Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BB injection on Week 2.
Number of Participants With Incidence of Any Common Treatment Site Response (CTR) Evaluated Using Participant Diaries	41 participants	45 participants

SECONDARY outcome

Timeframe: Baseline up to Week 6

Population: The SES included all participants who were enrolled into the study, randomized, and received an injection. Participants who were evaluable for this measure at given time period were included.

Outcome measures

Outcome measures
Measure	Test Product: BBL n=52 Participants Participants received treatment with Test Product BBL, injection, in one of the two NLF on Day 1. The BBL injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL injection on Week 2.	Control Product: BB n=52 Participants Participants received treatment with Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BB injection on Week 2.
Number of Participants With Incidence of Any CTR by Severity Evaluated Using Participant Diaries Mild	23 participants	24 participants
Number of Participants With Incidence of Any CTR by Severity Evaluated Using Participant Diaries Moderate	14 participants	18 participants
Number of Participants With Incidence of Any CTR by Severity Evaluated Using Participant Diaries Severe	4 participants	3 participants

SECONDARY outcome

Timeframe: Baseline up to Week 6

Outcome measures

Outcome measures
Measure	Test Product: BBL n=52 Participants Participants received treatment with Test Product BBL, injection, in one of the two NLF on Day 1. The BBL injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL injection on Week 2.	Control Product: BB n=52 Participants Participants received treatment with Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BB injection on Week 2.
Number of Participants With Incidence of Any CTR by Duration Evaluated Using Participant Diaries 1 to 3 days	16 participants	20 participants
Number of Participants With Incidence of Any CTR by Duration Evaluated Using Participant Diaries 4 to 7 days	14 participants	14 participants
Number of Participants With Incidence of Any CTR by Duration Evaluated Using Participant Diaries 8 to 17 days	8 participants	9 participants
Number of Participants With Incidence of Any CTR by Duration Evaluated Using Participant Diaries 15 to 30 days	3 participants	2 participants
Number of Participants With Incidence of Any CTR by Duration Evaluated Using Participant Diaries Greater than (>) 30 days	0 participants	0 participants

Adverse Events

Belotero Balance With or Without Lidocaine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Belotero Balance With or Without Lidocaine n=52 participants at risk Participants received treatment with Test Product BBL, injection, in one of the two NLF and Control Product BB without lidocaine, injection, in the contralateral NLF on Day 1. The BBL and BB injections were given in the alar-targus line to the oral commissure. The maximum treatment volume was 3 mL per NLF over two treatment sessions, on Day 1 and optional touch-up at Week 2. Participants who were eligible for an optional touch-up treatment to achieve optimal correction based on investigator's discretion received the BBL and BB injections on Week 2.
Nervous system disorders Headache	3.8% 2/52 • Baseline up to Week 6 The investigator queried the participant for adverse events at each visit.
Infections and infestations Gastroenteritis	1.9% 1/52 • Baseline up to Week 6 The investigator queried the participant for adverse events at each visit.
Injury, poisoning and procedural complications Contusion	1.9% 1/52 • Baseline up to Week 6 The investigator queried the participant for adverse events at each visit.
Skin and subcutaneous tissue disorders Skin tightness	1.9% 1/52 • Baseline up to Week 6 The investigator queried the participant for adverse events at each visit.

Additional Information

Public Disclosure Manager

Merz Pharmaceuticals GmbH

Phone: +49 69 1503 1

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
Publication restrictions are in place

Restriction type: OTHER