Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face
NCT ID: NCT03650387
Last Updated: 2023-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
207 participants
INTERVENTIONAL
2018-09-17
2020-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RADIESSE® (+) Lidocaine
RADIESSE® (+) Lidocaine
RADIESSE® (+) Lidocaine will be injected as per its current approved labelling and investigator's usual practice
Interventions
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RADIESSE® (+) Lidocaine
RADIESSE® (+) Lidocaine will be injected as per its current approved labelling and investigator's usual practice
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Merz North America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz Pharmaceuticals GmbH
Locations
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Rosenpark Research, Merz Investigational Site #490099
Darmstadt, , Germany
Universität Hamburg Fachbereich Chemie Institut für Biologie und Molekularbiologie , Merz Investigational Site #490095
Hamburg, , Germany
Derma Science GmbH Hamburg, Merz Investigational Site #490345
Hamburg, , Germany
Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #490371
Munich, , Germany
Dermatologie München-Neuhausen, Merz Investigational Site #490372
Munich, , Germany
Haut-und Lasercentrum, Merz Investigational Site #0490362
Potsdam, , Germany
Centroderm GmbH, Merz Investigational Site #490367
Wuppertal, , Germany
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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M900391005
Identifier Type: -
Identifier Source: org_study_id