Clinical trial NCT03650387: Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face
Official title: Open-label, Multicenter, Uncontrolled, Rater-blinded, Post-market Clinical Follow-up [PMCF] Study to Confirm Performance and Safety of RADIESSE® (+) Lidocaine in the Treatment of Nasolabial Folds, Marionette Lines, and/or Cheek Volume Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Signs of Facial Aging With Volume Loss in the Upper Cheeks, Nasolabial Folds and Marionette Lines
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merz Pharmaceuticals GmbH
First posted: 2018-08-28
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female greater than or equal to (\>=) 18 years old.
2. Participants seeking for dermal filler/volumising treatment in at least two of the following indications:

   * Nasolabial folds;
   * Marionette lines;
   * Cheek volume loss.
3. 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.
4. 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.
5. 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.

At least two of the inclusion criteria 3, 4, and 5 must be fulfilled. Depending on the fulfilled criteria, the respective indications will be treated.

Exclusion Criteria:

1. Any prior treatment with silicone, polymethyl methacrylate, fat injections, poly L-lactic acid or permanent dermal fillers in the face.
2. Any prior facial surgery, including facial plastic surgery, thread lift, any unknown treatment, or any surgical permanent implant that could interfere with performance assessments.
3. 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.
4. Prior treatment within the past 18 months with calcium hydroxylapatite in the area to be treated.
5. Prior treatment within the past 12 months with hyaluronic acid in the area to be treated.
6. 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.

Primary outcomes:
measure: 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)
timeFrame: At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)
measure: 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)
timeFrame: At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)
measure: 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)
timeFrame: At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)
measure: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up)
Secondary outcomes:
measure: 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)
timeFrame: 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)
measure: 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)
timeFrame: 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)
measure: 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)
timeFrame: 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)
measure: 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)
timeFrame: 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)
measure: 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)
timeFrame: 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)
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Rosenpark Research, Merz Investigational Site #490099
city: Hamburg
country: Germany
facility: Universität Hamburg Fachbereich Chemie Institut für Biologie und Molekularbiologie , Merz Investigational Site #490095
city: Hamburg
country: Germany
facility: Derma Science GmbH Hamburg, Merz Investigational Site #490345
city: Munich
country: Germany
facility: Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #490371
city: Munich
country: Germany
facility: Dermatologie München-Neuhausen, Merz Investigational Site #490372
city: Potsdam
country: Germany
facility: Haut-und Lasercentrum, Merz Investigational Site #0490362
city: Wuppertal
country: Germany
facility: Centroderm GmbH, Merz Investigational Site #490367
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Merz Medical Expert
role: STUDY_DIRECTOR
References:
citation: 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.