Moderate to severe glabellar lines (GL). MedDRA version: 21.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Alluzience®
Product Name: BTX-A-HAC NG (Dysport NG) = Alluzience
Product Code: BTX-A-HAC NG (Dysport NG)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Botulinum toxin t
Sponsors
Q-Med AB, part of the Galderma Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female 18 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous use of any botulinum toxin in facial area within 6 months prior to study treatment. 2. Female who is pregnant, breast feeding, or intends to conceive a child during the study. 3. Known allergy or hypersensitivity to any component of the study product or any botulinum toxin serotype. 4. Any known contraindication such as subject with bleeding disorder or subject currently using anticoagulants. 5. Previous use of any hyaluronic acid soft tissue augmentation therapy in the treated area within 3 months before baseline. 6. Previous soft tissue augmentation with any permanent (non-biodegradable such as silicone, polyacrylamide, etc) or semi-permanent (i.e., calcium hydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) product; lifting threads, or autologous fat in the treatment area. 7. Subject has any prior or current psychiatric illness (e.g. Psychosis, depression, anxiety), alcohol or drug abuse, or is taking antidepressant, anxiolytic, or antipsychotic medication that, in the Investigator's opinion, could affect the subject's safety and/or participation in the study. 8. Other concurrent medical conditions, therapy, or other condition that, in the Investigator's opinion, would interfere with the evaluation of the study medication, safety or efficacy, and/or put the subject at risk if he/she participates in the study. 9. Participation in an investigational device or drug study within 30 days prior to study treatment or plans to enroll in any other investigational study during participation in this study. 10. Study site personnel, close relatives of the study site personnel (e.g. parents, children, siblings, or spouse), employees or close relatives of employees at the Sponsor company.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate time needed to prepare Alluzience and powder BoNT A;Secondary Objective: 1.To evaluate preparation/reconstitution experience of Alluzience and powder BoNT-A. 2.To describe Investigator treatment experience when using Alluzience for the treatment of GL. 3.To describe usability of Alluzience and powder BoNT A for the treatment of GL after all subjects to be enrolled in the study have been treated at the site. 4.To describe subject perception of the treatment session when injected with Alluzience and powder BoNT-A for the treatment of GL. 5. To evaluate aesthetic improvement after treatment in the Alluzience treatment group. 6. To evaluate the subject’s level of satisfaction after treatment(s) in the Alluzience treatment group for the treatment of moderate to severe GL. 6) at baseline and month 1, 3, 5 and 6 after treatment. ;Primary end point(s): Time to prepare or reconstitute study product.;Timepoint(s) of evaluation of this end point: The majority of patients subjectively reported an effect within 2 to 3 days, including 23% of patients within 1 day. The proportion of responders by investigator assessment was statistically significantly higher for patients treated with Alluzience 1 month after injection compared to placebo (the primary endpoint) as well as at all other timepoints from 8 days up to 6 months | — |
Countries
Germany, United Kingdom
Contacts
Public ContactDaniel Seisdedos
Q-Med AB, part of the Galderma Group
Outcome results
None listed