Clinical trial NCT05277337: Study Comparing Treatment With Alluzience vs Reconstituted Toxin
Official title: A Phase IV, Randomized, Interventional, Study to Assess Subject Treatment Session Perception and Investigator Treatment Experience of Alluzience and Vacuum-Dried Botulinum Neurotoxin Type A for Aesthetic Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glabellar Frown Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2022-03-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase IV, open-label, randomized, interventional, two-armed, multi-centre study to investigate subject treatment perception and Investigator treatment experience when using Alluzience or vacuum-dried botulinum neurotoxin type A (powder BoNT-A) for treatment of glabellar lines (GL).

Detailed description: This is a Phase IV, open-label, randomized, interventional, two-armed, multi-centre study to investigate subject treatment perception and Investigator treatment experience when using Alluzience or vacuum-dried botulinum neurotoxin type A (powder BoNT-A) for treatment of glabellar lines (GL).

Eligibility criteria: Inclusion Criteria:

1. Female 18 to \< 65 years of age.
2. Moderate to severe GL at maximum frown as assessed by the Investigator.
3. Female of non-childbearing potential (i.e., postmenopausal \[absence of menstrual bleeding for 1 year prior to screening, without any other medical reason\], or has undergone hysterectomy or bilateral oophorectomy). OR Female of childbearing potential with a negative urine pregnancy test at screening and baseline, and agrees to use a highly effective and approved contraceptive method for the duration of the study.
4. Time and ability to complete the study and comply with instructions.
5. Understands the study requirements and signed the informed consent form (ICF).
6. Subjects who have planned to undergo aesthetic facial treatment with powder toxin at the study site.
7. Previous use of any approved botulinum toxin in facial areas.

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.

Primary outcomes:
measure: Time Needed to Prepare Alluzience and Powder BoNT A
timeFrame: Baseline (Day 0)
Secondary outcomes:
measure: Percentage of Participants Injected With Alluzience for Whom Investigator Did Not Face Technical Issue/Problems When Using a Ready-to-use Product as Compared to a Product to be Reconstituted
timeFrame: Baseline (Day 0)
measure: Percentage of Participants Injected With Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution
timeFrame: Baseline (Day 0)
measure: Investigator Treatment Session Questionnaire
timeFrame: Baseline (Day 0)
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Galderma Research Site 2003
city: Düsseldorf
country: Germany
facility: Galderma Research Site 2001
city: Düsseldorf
country: Germany
facility: Galderma Research Site 2002
city: Edinburgh
country: United Kingdom
facility: Galderma Research Site 1003
city: London
country: United Kingdom
facility: Galderma Research Site 1004
city: London
country: United Kingdom
facility: Galderma Research Site 1006
city: London
country: United Kingdom
facility: Galderma Research Site 1001
city: Street
country: United Kingdom
facility: Galderma Research Site 1002
Study officials:
References: