Spread of PrabotulinumtoxinA-xvfs Versus OnabotulinumtoxinA in the Treatment of Forehead Rhytides

NCT05807412 | Completed Early Phase 1 FDA Drug

• 1 other identifier: Pra vs Ona Spread 2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Ten subjects will be enrolled in the study. Each subject will have their left and right forehead randomly assigned to receive 4 units of PrabotulinumtoxinA-xvfs or OnabotulinumtoxinA. Subjects will be reassessed at 2 weeks for evaluation of rhytide diminution around each injection point to assess relative diffusion of each drug in the forehead.

Conditions

Rhytides

Keywords

Rhytides; Prabotulinumtoxin A-xvfs; Onabotulinumtoxin A; Botox; Jeaveau; Neuromodulator; Frontalis

Outcome Measures

Primary Outcomes (1)

• Surface area of rhytid diminution

  Primary endpoint is surface area of rhytid diminution. Surface area of rhytid reduction will be measured in centimeters squared (incorporating length and width measurements) two-weeks post-injection to assess differences, if any, in rhytid reduction on each side of the forehead by the blinded investigator.

  14 days post-treatment

Secondary Outcomes (2)

• 5-point photonumeric scale for resting or static and hyperkinetic or dynamic horizontal forehead lines

  14 days post-treatment

• Adverse events

  14 days post-treatment

Study Arms (2)

Experimental half

EXPERIMENTAL

Each subject will be randomized to have either their right forehead or left forehead treated with 4 units or 0.1 cc of prabotulinumtoxinA 2.5 cm above the orbital rim.

Drug: PrabotulinumtoxinA-Xvfs

Comparator half

ACTIVE COMPARATOR

Each subject will be randomized to have either their right forehead or left forehead treated with 4 units or 0.1 cc of onabotulinumtoxinA 2.5 cm above the orbital rim.

Drug: OnabotulinumtoxinA

Interventions

PrabotulinumtoxinA-Xvfs DRUG

All subjects will receive one injection of 4 units or 0.1 cc of prabotulinumtoxin A into the frontalis at a single point 2.5 cm above the orbital rim at the mid-pupillary line. The preparation of the 100-unit vial of prabotulinumtoxinA will be reconstituted gently and without shaking with 2.5 cc of 0.9% preserved normal saline solution. The investigator performing the injections will reconstitute study vials. Subjects will be injected intramuscularly using a hubless tuberculin syringe. Injections will be done at a 90-degree angle or perpendicular to the skin surface. The target sites will be the mid-line of the pupil and 2.5 cm above the orbital rim.

Also known as: Jeaveau

Experimental half

OnabotulinumtoxinA DRUG

All subjects will receive one injection of 4 units or 0.1 cc of onabotulinumtoxinA into the frontalis at a single point 2.5 cm above the orbital rim at the mid-pupillary line. The preparation of the 100-unit vial of onabotulinumtoxinA will be reconstituted gently and without shaking with 2.5 cc of 0.9% preserved normal saline solution. The investigator performing the injections will reconstitute study vials. Subjects will be injected intramuscularly using a hubless tuberculin syringe. Injections will be done at a 90-degree angle or perpendicular to the skin surface. The target sites will be the mid-line of the pupil and 2.5 cm above the orbital rim.

Also known as: Botox

Comparator half

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Moderate-to-severe dynamic forehead rhytides and none-to-minimal static forehead rhytides (score of 3 to 4 and score of 0 to 1, respectively, using a 5-point validated grading scale for forehead lines)1
• Subjects in good general health based on investigator's judgment and medical history
• Willingness to have facial exams and photos performed
• Must be willing to give and sign an informed consent form and photographic release form
• Negative urine pregnancy test result at the time of study entry (if applicable)
• Must be willing to comply with study treatments and complete the entire course of the study

You may not qualify if:

• Pregnant or breastfeeding
• Previous treatment with botulinum toxin of any serotype in the forehead area within the last 6 months
• History of permanent or long-acting fillers such as silicone, Sculptra® or Radiesse® in the treatment area
• Current history of substance abuse, including alcohol or other drugs
• Concurrent use of medications that affect neuromuscular transmission such as aminoglycoside antibiotics, anticholinesterases, lincosamides and polymyxins
• Marked facial asymmetry
• History of facial nerve palsy
• Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
• Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
• Known allergy or hypersensitivity to botulinum toxin preparation
• Any planned surgical intervention to the face for the duration of the trial
• Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
• Subjects with an active bacterial, viral, or fungal infection of the treatment areas
• Subjects with tattoos or excessive scarring in the treatment areas
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study

Sponsors & Collaborators

• Lupo Center for Aesthetic and General Dermatology: lead
• Evolus, Inc.: collaborator

Study Sites (1)

Lupo Center for Aesthetic and General Dermatology

New Orleans, Louisiana, 70124, United States

Location

Related Publications (5)

• Carruthers A, Carruthers J, Hardas B, Kaur M, Goertelmeyer R, Jones D, Rzany B, Cohen J, Kerscher M, Flynn TC, Maas C, Sattler G, Gebauer A, Pooth R, McClure K, Simone-Korbel U, Buchner L. A validated grading scale for marionette lines. Dermatol Surg. 2008 Nov;34 Suppl 2:S167-72. doi: 10.1111/j.1524-4725.2008.34366.x.

  PMID: 19021675 BACKGROUND

• Beer KR, Shamban AT, Avelar RL, Gross JE, Jonker A. Efficacy and Safety of PrabotulinumtoxinA for the Treatment of Glabellar Lines in Adult Subjects: Results From 2 Identical Phase III Studies. Dermatol Surg. 2019 Nov;45(11):1381-1393. doi: 10.1097/DSS.0000000000001903.

  PMID: 30893162 BACKGROUND

• Lorenc ZP, Adelglass JM, Avelar RL, Baumann L, Beer KR, Cohen JL, Cox SE, Dayan SH, Dover JS, Downie JB, Draelos ZD, Goldman MP, Gross JE, Joseph JH, Kaufman-Janette J, Moy RL, Nestor M, Schlessinger J, Smith SR, Weiss RA. The Second of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients. Aesthet Surg J. 2021 Nov 12;41(12):1423-1438. doi: 10.1093/asj/sjaa382.

  PMID: 33944913 BACKGROUND

• Taylor SC, Grimes PE, Joseph JH, Jonker A, Avelar RL. PrabotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines in Adult Patients With Skin of Color: Post Hoc Analyses of the US Phase III Clinical Study Data. Dermatol Surg. 2021 Apr 1;47(4):516-521. doi: 10.1097/DSS.0000000000002864.

  PMID: 33165078 BACKGROUND

• Hsu TS, Dover JS, Arndt KA. Effect of volume and concentration on the diffusion of botulinum exotoxin A. Arch Dermatol. 2004 Nov;140(11):1351-4. doi: 10.1001/archderm.140.11.1351.

  PMID: 15545544 BACKGROUND

MeSH Terms

Interventions

prabotulinumtoxin A; 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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The left and right-side assignment will be determined based on the treating physician's selection of a sealed envelope using random numbers on the treatment day.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject will be randomized to have either their right forehead or left forehead treated with 4 units or 0.1 cc of prabotulinumtoxinA 2.5 cm above the orbital rim. As a control, the contralateral forehead half will receive 4 units or 0.1 cc of onabotulinumtoxinA at the same dilution at the same time.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 11, 2023
• Study Start: May 1, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)