Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face

NCT03650387 | Completed Results FDA Device

• 1 other identifier: M900391005
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objective is to collect clinical data to confirm performance and safety for RADIESSE® (+) Lidocaine, when used in accordance with its labelling in the treatment of nasolabial folds, marionette lines and/or upper cheek volume loss.

Conditions

Signs of Facial Aging With Volume Loss in the Upper Cheeks, Nasolabial Folds and Marionette Lines

Outcome Measures

Primary Outcomes (4)

• Responder Rate for Nasolabial Folds Based on the Blinded Rater's Evaluation on the Merz Nasolabial Folds Scale (MNLFS) at Week 12/16 (Depending on Touch-up)

  The MNLFS was used to assess the severity of nasolabial folds. The assessment was performed separately for the left and the right nasolabial fold by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MNLFS was a 5 point scale ranging as: 0 (no folds), 1 (mild folds), 2 (moderate folds), 3 (severe folds), 4 (very severe folds). Responders rate was defined as percentage of participants who achieved improvement of greater than or equal to (\>=) 1 point in both folds (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up.

  At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)

• Responder Rate for Marionette Lines Based on the Blinded Rater's Evaluation on the Merz Marionette Lines Scale (MMLS) at Week 12/16 (Depending on Touch-up)

  The MMLS was used to assess the severity of marionette lines. The assessment was performed separately for the left and the right marionette line by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MMLS was a 5 point scale ranging as: 0 (no lines), 1 (mild lines), 2 (moderate lines), 3 (severe lines), 4 (very severe lines). Responders rate was defined as percentage of participants who achieved improvement of \>=1 point in both marionette lines (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up.

  At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)

• Responder Rate for Cheek Fullness Based on the Blinded Rater's Evaluation on the Merz Upper Cheek Fullness Scale (MUCFS) at Week 12/16 (Depending on Touch-up)

  The MUCFS was used to assess the severity of volume loss of upper cheeks. The assessment was performed separately for the left and the right cheek by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MUCFS was a 5 point scale ranging as: 0 (full upper cheek), 1 (mildly sunken upper cheek), 2 (moderately sunken upper cheek), 3 (severely sunken upper cheek), 4 (very severely sunken upper cheek). Responders rate was defined as percentage of participants who achieved improvement of \>=1 point in both cheeks (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up.

  At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)

• Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)

  Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up)

Secondary Outcomes (5)

• Responder Rate for Nasolabial Folds Based on the Blinded Rater's Evaluation on the MNLFS at Week 4 (Prior to Optional Touch-up), at Week 24/28, at Week 48/52, and at Week 72/76 (Depending on Touch-up)

  At Week 4 (prior to optional touch-up); at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up)

• Responder Rate for Marionette Lines Based on the Blinded Rater's Evaluation on the MMLS at Week 4 (Prior to Optional Touch-up), at Week 24/28, at Week 48/52, and at Week 72/76 (Depending on Touch-up)

  At Week 4 (prior to optional touch-up); and at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up)

• Responder Rate for Cheek Fullness Based on the Blinded Rater's Evaluation on the MUCFS at Week 4 (Prior to Optional Touch-up), at Week 24/28, at Week 48/52, and at Week 72/76 (Depending on Touch-up)

  At Week 4 (prior to optional touch-up); at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up)

• Number of Participants Based on Treating Investigator's Evaluation of the Global Aesthetic Improvement on the iGAIS at Week 4 (Prior to Optional Touch-up), Week 12/16, Week 24/28, Week 48/52, and Week 72/76 (Depending on Touch-up Performed)

  At Week 4 (prior to optional touch-up); at Weeks 12, 24, 48 and 72 (for participants with no touch-up) or at Weeks 16, 28, 52 and 76 (for participants with touch-up)

• Number of Participants Based on Participant's Evaluation of the Global Aesthetic Improvement on the sGAIS at Week 4 (Prior to Optional Touch-up), Week 12/16, Week 24/28, Week 48/52, and Week 72/76 (Depending on Touch-up Performed)

  At Week 4 (prior to optional touch-up); at Weeks 12, 24, 48 and 72 (for participants with no touch-up) or at Weeks 16, 28, 52 and 76 (for participants with touch-up)

Study Arms (1)

RADIESSE® (+) Lidocaine

EXPERIMENTAL

Device: RADIESSE® (+) Lidocaine

Interventions

RADIESSE® (+) Lidocaine DEVICE

RADIESSE® (+) Lidocaine will be injected as per its current approved labelling and investigator's usual practice

Also known as: Radiesse® Injectable Dermal Filler with Lidocaine

RADIESSE® (+) Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female greater than or equal to (\>=) 18 years old.
• Participants seeking for dermal filler/volumising treatment in at least two of the following indications:
• Nasolabial folds;
• Marionette lines;
• Cheek volume loss.
• Nasolabial folds volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Nasolabial Folds Scale with symmetrical rating at Day 1 as determined by the blinded rater and confirmed by the treating investigator afterwards.
• Marionette lines volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Marionette Lines Scale with symmetrical rating at Day 1 as determined by the blinded rater and confirmed by the treating investigator afterwards.
• Upper cheek volume deficit of moderate to very severe intensity (grade 2 to 4) on the Merz Upper Cheek Fullness Scale with symmetrical rating at Day 1 as determined by the blinded rater and confirmed by the treating investigator afterwards.

You may not qualify if:

• Any prior treatment with silicone, polymethyl methacrylate, fat injections, poly L-lactic acid or permanent dermal fillers in the face.
• Any prior facial surgery, including facial plastic surgery, thread lift, any unknown treatment, or any surgical permanent implant that could interfere with performance assessments.
• Prior treatment within the past 24 months with porcine based collagen fillers or with volumisers (e.g., Belotero® Volume or others) in the area to be treated.
• Prior treatment within the past 18 months with calcium hydroxylapatite in the area to be treated.
• Prior treatment within the past 12 months with hyaluronic acid in the area to be treated.
• Prior treatment within the past 6 months with facial dermal therapies (e.g. epilation, ultraviolet irradiation, radiofrequency, facial ablative or non-ablative laser treatment, microderm abrasion, mechanical or chemical peels, non-invasive skin-tightening \[e.g., Ultherapy, Thermage\] or surgical procedures) or plans to receive this during participation in the study.

Sponsors & Collaborators

• Merz North America, Inc.: lead
• Merz Pharmaceuticals GmbH: collaborator

Study Sites (7)

Rosenpark Research, Merz Investigational Site #490099

Darmstadt, 64283, Germany

Location

Universität Hamburg Fachbereich Chemie Institut für Biologie und Molekularbiologie , Merz Investigational Site #490095

Hamburg, 20146, Germany

Location

Derma Science GmbH Hamburg, Merz Investigational Site #490345

Hamburg, 22609, Germany

Location

Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #490371

Munich, 80539, Germany

Location

Dermatologie München-Neuhausen, Merz Investigational Site #490372

Munich, 80636, Germany

Location

Haut-und Lasercentrum, Merz Investigational Site #0490362

Potsdam, 14467, Germany

Location

Centroderm GmbH, Merz Investigational Site #490367

Wuppertal, 42287, Germany

Location

Related Publications (1)

• Pavicic T, Sattler G, Fischer T, Dirschka T, Kerscher M, Gauglitz G, Dersch H, Kravtsov M, Heide I, Prager W. Calcium Hydroxyapatite Filler With Integral Lidocaine CaHA (+) for Soft Tissue Augmentation: Results from an Open-Label Multicenter Clinical Study. J Drugs Dermatol. 2022 May 1;21(5):481-487. doi: 10.36849/JDD.6737.

  PMID: 35533030 BACKGROUND

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals GmbH

Aesthetic.Trials@merz.com

+49 69 1503 1

Study Officials

• Merz Medical Expert

  Merz Pharmaceuticals GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Rater-blinded live evaluation of scale scores (the blinded rater does not know which indications were treated)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 28, 2018
• Study Start: September 17, 2018
• Primary Completion: May 26, 2020
• Study Completion: May 26, 2020
• Last Updated: December 5, 2023
• Results First Posted: June 18, 2021

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)