None listed
Conditions
Brief summary
This is a global, prospective, longitudinal, non-interventional, multi-center study to collect participant and physician satisfaction, and treatment experience with Relfydess in routine clinical practice. The primary objective of the study is to evaluate participant satisfaction after three treatment cycles with Relfydess in the GL and/or LCL..
Interventions
Relfydess is a next-generation, ready-to-use liquid botulinum toxin type A to treat moderate-to-severe frown lines and crow's feet. Relfydess comes as a clear, colorless liquid that is ready to use without the need for reconstitution.
There are 3 treatments. The patient will be seen about 2-3 weeks after each treatment with a final follow up visit 3-6 months after the last treatment.
There will be Patient and Physician pre and post treatment satisfaction questionnaires when using Botulinum t
Relfydess is a next-generation, ready-to-use liquid botulinum toxin type A to treat moderate-to-severe frown lines and crow's feet. Relfydess comes as a clear, colorless liquid that is ready to use without the need for reconstitution. There are 3 treatments. The patient will be seen about 2-3 weeks after each treatment with a final follow up visit 3-6 months after the last treatment. There will be Patient and Physician pre and post treatment satisfaction questionnaires when using Botulinum toxin (Relfydess) in the face to improve the appearance of moderate-to-severe vertical frown lines (glabellar lines) and Crow’s feet (lateral canthal lines) in adults under 65. The questionnaires will be completed on paper and will take approximately 5-10 minutes to complete.
Sponsors
Galderma SA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants eligible for study participation should meet the following criteria: • Adult male or female. • Prior to and independent of study, participant is prescribed long term treatment of their GL and LCL with botulinum toxin. • Prior to and independent of the study participation, physician intended to treat the participant with Relfydess. • Time and ability to complete the study and comply with instructions. • Understands the study requirements and signed the informed consent form (ICF).
Exclusion criteria
Participants are not eligible for participation in this non-interventional study (NIS), if any of the following conditions applies: • Hypersensitive to Relfydess or its excipients. • Presence of contraindications to treatment as specified in the local product information. • Participant is at risk for precautions, warnings, and/or contraindications to Relfydess as specified in the local product information. • Participant has an infection in the proposed treatment area. • Participant has had treatment failure experience with other toxins. • Participant has received any botulinum toxin treatment within 5 months prior to the 1st treatment. • Pregnant or breast feeding female, or female intending to get pregnant during the study. • Participation in a clinical study, interventional or non interventional, within 30 days prior to study entry (signature of informed consent).
Outcome results
None listed