Study Comparing Treatment With Alluzience vs Reconstituted Toxin

Glabellar Frown Lines Clinical Trial

— STAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05277337
• Other study ID #: 05PF2005
• Secondary ID: 2021-004748-62
• Status: Completed
• Phase: Phase 4
• Start date: February 4, 2022
• Est. completion date: October 12, 2022

Study information

• Verified date: June 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Biological:
• Alluzience
Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection
• powder BoNT-A (BOTOX/Vistabel)
Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection

Locations

Country	Name	City	State
Germany	Galderma Research Site 2003	Bochum
Germany	Galderma Research Site 2001	Düsseldorf
Germany	Galderma Research Site 2002	Düsseldorf
United Kingdom	Galderma Research Site 1003	Edinburgh
United Kingdom	Galderma Research Site 1001	London
United Kingdom	Galderma Research Site 1004	London
United Kingdom	Galderma Research Site 1006	London
United Kingdom	Galderma Research Site 1002	Street

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Needed to Prepare Alluzience and Powder BoNT A	Time to prepare Alluzience and powder Bont A according to protocol was reported.	Baseline (Day 0)
Secondary	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	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, assessed using answers within each answer option (strongly agree, agree, neither agree nor disagree, disagree and strongly disagree) was reported.	Baseline (Day 0)
Secondary	Percentage of Participants Injected With Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution	Percentage of participants injected with Powder Bont-A for whom investigator experienced issues while reconstitution was assessed using a questionnaire (Yes/No). Percentage of participants with answer "Yes" was reported.	Baseline (Day 0)
Secondary	Investigator Treatment Session Questionnaire	Treating investigators who injected participant with Alluzience answered questions 1 through 12 of the investigator treatment questionnaire for each participant at baseline. The options for each question were strongly agree, agree, neither agree nor disagree, disagree and strongly disagree.	Baseline (Day 0)