Subjects Desiring Lip AugmentationELISENCT03256942
Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation
A study testing Etermis 4® in people with Subjects Desiring Lip Augmentation, run by Merz Pharmaceuticals GmbH at 6 sites in Germany.
Trial summary
Primary objective: To evaluate the sensitivity of the Merz Lip Fullness Assessment Scale (MLFAS). Secondary objectives: To evaluate the clinical aesthetic improvement outcome in lips appearance four weeks after Etermis 4® injection. To evaluate safety/tolerability of Etermis 4® treatment in lips. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects Desiring Lip Augmentation
- What is being tested?
- Etermis 4®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesGermany
- Study dates
- 16 Aug 2017to 17 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male or female study subjects with thin to medium lips volume (grade 1 to 2 on MLFAS), seeking for hyaluronic acid (HA) for lips volume augmentation in ≥1-point improvement on the MLFAS on both the upper and lower lips and fulfilling the criteria listed in the Instruction for Use (IFU) of the Study Medical Device to be injected.
Who cannot join
- Subjects with a medical condition and/or medication according to current IFU which is contra indicated for HA filler treatment, or prior facial surgeries or surgical permanent implants, lips augmentation treatment or other aesthetic procedure in the face that could interfere with performance assessment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Dermatologische Praxis, Merz Investigational Site #0490345
Hamburg, Hanse Stadt Hamburg, 22609
Universität Hamburg, FB Chemie und Molekularbiologie, Merz Investigational Site #0490095
Hamburg, 20146
DRK Kliniken Nordhessen, Merz Investigational Site #0490309
Kassel, Hesse, 34121
Dermatologische Privatpraxis, Merz Investigational Site #0490371
Munich, Bavaria, 80539
Dermatologie München-Neuhausen, Merz Investigational Site #0490372
Munich, Bavaria, 80636
Haut & Laserzentrum Potsdam, Merz Investigational Site #0490362
Potsdam, Brandenburg, 14467
About this study
Primary objective:
- To evaluate the sensitivity of the Merz Lip Fullness Assessment Scale (MLFAS).
Secondary objectives:
- To evaluate the clinical aesthetic improvement outcome in lips appearance four weeks after Etermis 4® injection.
- To evaluate safety/tolerability of Etermis 4® treatment in lips.
- Conditions
- Subjects Desiring Lip Augmentation
- Being tested
- Etermis 4®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etermis 4®Device
Etermis 4® is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (HA) of non-animal origin.
| Study group | Role | What they receive |
|---|---|---|
| Etermis 4® Treatment | Experimental | Etermis 4® will be applied according to the method of administration described in the current version of the Instructions for Use (IFU) until optimal cosmetic result is obtained at the discretion of the treating investigator.
Single injection session, injections into the lips. Receives: Device: Etermis 4® |
| No Treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate for treated and for untreated lips at Visit 2 (Week 4), as assessed live by the blinded rater using the Merz Lip Fullness Assessment Scale (MLFAS).
Response is defined as ≥ 1-point improvement on both the upper and lower lips compared to baseline. Upper and lower lips are to be assessed separately.
The MLFAS is a 5-point scale ranging from 0 (very thin) to 4 (very full). A positive number change from baseline indicates improvement.
Measured: Week 4
Secondary outcomes (3)
Change from baseline for treated and untreated lips at Visit 2 (Week 4) as assessed live by the blinded rater using MLFAS
Upper and lower lips are to be assessed separately. The MLFAS is a 5-point scale ranging from 0 (very thin) to 4 (very full). A positive number change from baseline indicates improvement.
Measured: Week 4
Agreement rate in treated subjects between MLFAS responders and Investigator Global Aesthetic Improvement Scale (Investigator-GAIS) responders at Visit 2 (Week 4).
Agreement for a subject is reached if he/she is a responder for both MLFAS and Investigator-GAIS or he/she is a non-responder for both MLFAS and Investigator-GAIS. GAIS response is defined as at least a "+1 improved" rating on the Investigator -GAIS.
The MLFAS is a 5-point scale ranging from 0 (very thin) to 4 (very full). A positive number change from baseline indicates improvement. The Investigator-GAIS is a 7-point scale ranging from -3 (very much worse) to +4 (very much improved).
Measured: Week 4
Agreement rate in treated subjects between MLFAS responders and FACE-Q Satisfaction with Lips responders at Visit 2 (week 4).
Agreement for a subject is reached if he/she is a responder for both MLFAS and FACE-Q Satisfaction with Lips or he/she is a non-responder for both MLFAS and FACE-Q Satisfaction with Lips. MLFAS is assessed by a blinded rater. MLFAS response is defined as ≥ 1-point improvement on both the upper and lower lips compared to baseline. FACE-Q Satisfaction with Lips is assessed by the treated subject at baseline and at Visit 2. FACE-Q Satisfaction with Lips response is defined as a positive change in the FACE-Q score.
The MLFAS is a 5-point scale ranging from 0 (very thin) to 4 (very full). A positive number change from baseline indicates improvement. FACE-Q scores are derived from a questionaire of 10 questions relating to the satisfaction with lips appearance. Answers range from 1 (very dissatisfied) to 4 (very satisfied).
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start16 Aug 2017
- Primary completion17 Nov 2017
- Study completion17 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Desiring Lip AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256942
- Sponsor's protocol ID
- M900741002
- Acronym
- ELISE
- Status last verified
- Nov 2017
- First submitted
- 17 Aug 2017
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation
- ClinicalTrials.gov ID
- NCT03256942
- Acronym / sponsor ID
- ELISE / M900741002
- Conditions
- Subjects Desiring Lip Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
- To evaluate the sensitivity of the Merz Lip Fullness Assessment Scale (MLFAS).
Secondary objectives:
- To evaluate the clinical aesthetic improvement outcome in lips appearance four weeks after Etermis 4® injection.
- To evaluate safety/tolerability of Etermis 4® treatment in lips.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etermis 4® Treatment | Experimental | Device: Etermis 4®Etermis 4® will be applied according to the method of administration described in the current version of the Instructions for Use (IFU) until optimal cosmetic result is obtained at the discretion of the treating investigator. Single injection session, injections into the lips. |
| No Treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male or female study subjects with thin to medium lips volume (grade 1 to 2 on MLFAS), seeking for hyaluronic acid (HA) for lips volume augmentation in ≥1-point improvement on the MLFAS on both the upper and lower lips and fulfilling the criteria listed in the Instruction for Use (IFU) of the Study Medical Device to be injected.
Key exclusion criteria (1 listed)
- Subjects with a medical condition and/or medication according to current IFU which is contra indicated for HA filler treatment, or prior facial surgeries or surgical permanent implants, lips augmentation treatment or other aesthetic procedure in the face that could interfere with performance assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etermis 4®Etermis 4® is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (HA) of non-animal origin. | Device | Etermis 4® Treatment |
Primary outcome
Responder rate for treated and for untreated lips at Visit 2 (Week 4), as assessed live by the blinded rater using the Merz Lip Fullness Assessment Scale (MLFAS).
Time frame: Week 4
Response is defined as ≥ 1-point improvement on both the upper and lower lips compared to baseline. Upper and lower lips are to be assessed separately. The MLFAS is a 5-point scale ranging from 0 (very thin) to 4 (very full). A positive number change from baseline indicates improvement.
3 secondary outcomes
Change from baseline for treated and untreated lips at Visit 2 (Week 4) as assessed live by the blinded rater using MLFAS
Time frame: Week 4
Agreement rate in treated subjects between MLFAS responders and Investigator Global Aesthetic Improvement Scale (Investigator-GAIS) responders at Visit 2 (Week 4).
Time frame: Week 4
Agreement rate in treated subjects between MLFAS responders and FACE-Q Satisfaction with Lips responders at Visit 2 (week 4).
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz Pharmaceuticals GmbH
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etermis 4® in people with Subjects Desiring Lip Augmentation, run by Merz Pharmaceuticals GmbH at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rate for treated and for untreated lips at Visit 2 (Week 4), as assessed live by the blinded rater using the Merz Lip Fullness Assessment Scale (MLFAS). (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.