Study Comparing Treatment With Alluzience vs Reconstituted Toxin

NCT05277337 | Completed Phase 4 Results

• 2 other identifiers: 05PF20052021-004748-62
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 8

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).

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  Baseline (Day 0)

• Percentage of Participants Injected With Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution

  Baseline (Day 0)

• Investigator Treatment Session Questionnaire

  Baseline (Day 0)

Study Arms (2)

Group 1 (Alluzience)

EXPERIMENTAL

Single treatment at the baseline visit with Alluzience. Glabellar lines will be treated with 10 U/0.05 mL per injection point. In total 50 s.U in 0.25 mL for 5 injection points.

Biological: Alluzience

Group 2 (powder BoNT-A: BOTOX/Vistabel)

ACTIVE COMPARATOR

Single treatment at the baseline visit with powder BoNT-A (BOTOX/Vistabel). Glabellar lines will be treated with 4 U/0.1 mL per injection point. In total 20 U in 0.5 mL for 5 injection points.

Biological: powder BoNT-A (BOTOX/Vistabel)

Interventions

Alluzience BIOLOGICAL

Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection

Group 1 (Alluzience)

powder BoNT-A (BOTOX/Vistabel) BIOLOGICAL

Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection

Group 2 (powder BoNT-A: BOTOX/Vistabel)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female 18 to \< 65 years of age.
• Moderate to severe GL at maximum frown as assessed by the Investigator.
• 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.
• Time and ability to complete the study and comply with instructions.
• Understands the study requirements and signed the informed consent form (ICF).
• Subjects who have planned to undergo aesthetic facial treatment with powder toxin at the study site.
• Previous use of any approved botulinum toxin in facial areas.

You may not qualify if:

• Previous use of any botulinum toxin in facial area within 6 months prior to study treatment.
• Female who is pregnant, breast feeding, or intends to conceive a child during the study.
• Known allergy or hypersensitivity to any component of the study product or any botulinum toxin serotype.
• Any known contraindication such as subject with bleeding disorder or subject currently using anticoagulants.
• Previous use of any hyaluronic acid soft tissue augmentation therapy in the treated area within 3 months before baseline.
• 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (8)

Galderma Research Site 2003

Bochum, 44791, Germany

Location

Galderma Research Site 2001

Düsseldorf, 40212, Germany

Location

Galderma Research Site 2002

Düsseldorf, 40545, Germany

Location

Galderma Research Site 1003

Edinburgh, EH10 4BE, United Kingdom

Location

Galderma Research Site 1004

London, W1G 9PF, United Kingdom

Location

Galderma Research Site 1006

London, W1G 9PF, United Kingdom

Location

Galderma Research Site 1001

London, W1W 7JF, United Kingdom

Location

Galderma Research Site 1002

Street, BA16 0HY, United Kingdom

Location

Related Publications (1)

• Chadha P, Gerber PA, Hilton S, Molina B, Haq S, Partridge J, Wong V, Hoffmann K, Persson C, Prygova I. Ready-to-use abobotulinumtoxinA solution versus powder botulinumtoxinA for treatment of glabellar lines: Investigators' and subjects' experience in a Phase IV study. J Cosmet Dermatol. 2024 Sep;23(9):2857-2866. doi: 10.1111/jocd.16359. Epub 2024 May 28.

  PMID: 38807515 DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: February 4, 2022
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: February 16, 2024
• Results First Posted: February 16, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); GB (5)