Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area

NCT05167864 | Completed Results

• 1 other identifier: 849045
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to use 3D imaging to evaluate the effects of four FDA approved neuromodulators on facial lines, wrinkles and animation. Participation is available to women who have never had a cosmetic procedure above the malar region nor a treatment with a neuromodulator within 12 months. All subjects will undergo 3D imaging using the VECTRA M3 (Canfield Scientific, Inc, Fairfield, NJ) prior to treatment with a neuromodulator in order to determine their baseline dimensions. Imaging will be repeated post injection to determine change over time.

Conditions

Cosmetic Techniques

Keywords

minimally invasive procedures; neurotoxins; cosmetic; Botox; eyebrow area; glabella; Dysport; Jeuveau; Xeomin; forehead; cosmetic injections; facial rejuvenation; wrinkle reduction

Outcome Measures

Primary Outcomes (1)

• the Change in Dynamic Strain in the Glabella Area After Injection Over Time

  The change in dynamic strain of the glabella area after injection using 3D facial imaging measurements over time At each visit two images were captured, one neutral and one dynamic. The neutral face was relaxed and served as a reference while the dynamic face was the subject's expression when asked to furrow their glabella by frowning (compressed face). A decrease in strain indicates reduced compression, as there is a smaller difference between the neutral face and the dynamic, or compressed, face.

  day 3, day 30, day 90, day 180

Secondary Outcomes (1)

• Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime

  baseline, day 3, day 30, day 90, day 180

Study Arms (4)

OnabotulinumtoxinA

ACTIVE COMPARATOR

Botox

Drug: Onabotulinumtoxina for Injection

AbobotulinumtoxinA

ACTIVE COMPARATOR

Dysport

Drug: Abobotulinumtoxina for Injection

IncobotulinumtoxinA

ACTIVE COMPARATOR

Xeomin

Drug: IncobotulinumtoxinA for Injection

PrabotulinumtoxinA

ACTIVE COMPARATOR

Jeuveau

Drug: PrabotulinumtoxinA for Injection

Interventions

Onabotulinumtoxina for Injection DRUG

cosmetic injection into the glabella area (eyebrow area)

Also known as: Botox

OnabotulinumtoxinA

Abobotulinumtoxina for Injection DRUG

cosmetic injection into the glabella area (eyebrow area)

Also known as: Dysport

AbobotulinumtoxinA

IncobotulinumtoxinA for Injection DRUG

cosmetic injection into the glabella area (eyebrow area)

Also known as: Xeomin

IncobotulinumtoxinA

PrabotulinumtoxinA for Injection DRUG

cosmetic injection into the glabella area (eyebrow area)

Also known as: Jeuveau

PrabotulinumtoxinA

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years of age
• Interested in glabellar injections to reduce rhytids and facial strain
• Participants must sign the informed consent form

You may not qualify if:

• Females under 30 or above 65 years of age
• Males
• Those who have received glabellar injections for rhytids \<12 months
• Underwent cosmetic surgical procedure above the malar region
• Those with a condition that affects facial expression, such as prior stroke

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Lemdani MS, Honig SE, Habarth-Morales TE, Davis HD, Niu EF, Ewing JN, Broach RB, Serletti JM, Percec I. Comparison of Botulinum Toxin A Formulations for Glabellar Strain Treatment in Women: A Double-Blind Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):723-730. doi: 10.1001/jamadermatol.2025.1335.

  PMID: 40434770 DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A; Injections; abobotulinumtoxinA; incobotulinumtoxinA; prabotulinumtoxin 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; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Ivona Percec, PhD, MD
• Organization: University of Pennsylvania

ivona.percec@pennmedicine.upenn.edu

215-662-7300

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: blinding of participant and provider administering the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial in which patients will be randomly assigned into one of four groups

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 22, 2021
• Study Start: March 4, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2024-12

Locations

US (1)