Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSEĀ® (+) Lidā¦ (NCT03650387) | Clinical Trial Compass
CompletedNot Applicable
Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSEĀ® (+) Lidocaine) in the Treatment of Ageing Signs in the Face
Germany207 participantsStarted 2018-09-17
Plain-language summary
The primary objective is to collect clinical data to confirm performance and safety for RADIESSEĀ® (+) Lidocaine, when used in accordance with its labelling in the treatment of nasolabial folds, marionette lines and/or upper cheek volume loss.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Male or female greater than or equal to (\>=) 18 years old.
ā. Participants seeking for dermal filler/volumising treatment in at least two of the following indications:
ā. 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.
ā. 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.
ā. 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
ā. Any prior treatment with silicone, polymethyl methacrylate, fat injections, poly L-lactic acid or permanent dermal fillers in the face.
ā. Any prior facial surgery, including facial plastic surgery, thread lift, any unknown treatment, or any surgical permanent implant that could interfere with performance assessments.
ā. Prior treatment within the past 24 months with porcine based collagen fillers or with volumisers (e.g., BeloteroĀ® Volume or others) in the area to be treated.
ā. Prior treatment within the past 18 months with calcium hydroxylapatite in the area to be treated.
What they're measuring
1
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)
2
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)
3
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)
4
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)
ā. Prior treatment within the past 12 months with hyaluronic acid in the area to be treated.
ā. 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.