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Completed

NCT Number: NCT03256942

Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation

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.

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Key information

Conditions

Subjects Desiring Lip Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatologie München-Neuhausen, Merz Investigational Site #0490372, Munich, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Etermis 4®

Device

Etermis 4® is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (HA) of non-animal origin.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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 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).

  3. Agreement rate in treated subjects between MLFAS responders and FACE-Q Satisfaction with Lips responders at Visit 2 (week 4).

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Acronym: ELISE

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2017
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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