Dysport Dose-Ranging Treatment of Platysmal Bands

NCT04886167 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: CTBH-01-2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blinded, dose-ranging study in the US to assess the efficacy, safety, and duration of response of abobotulinumtoxinA for the treatment of moderate to severe platysmal bands.

Conditions

Platysma Bands

Keywords

AbobotulinumtoxinA; Platysmal Bands

Outcome Measures

Primary Outcomes (1)

• Investigator Live Assessment (Dynamic) - 1 month

  Responder rate at 1 month using the Investigator Live Assessment 5-point Photographic Scale at maximum contraction. The scale ranges from 1 to 5, with higher scores meaning a worse outcome.

  1 month

Secondary Outcomes (5)

• Investigator Live Assessment (Dynamic)

  5 months

• Subject Self Assessment (Dynamic)

  5 months

• Investigator Live Assessment (At Rest)

  5 months

• Subject Self Assessment (At Rest)

  5 months

• Response Duration

  5 months

Study Arms (3)

120U abobotulinumtoxinA

ACTIVE COMPARATOR

Treatment of platysmal bands using a total of 120 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.025mL (5 U). At the 14 day visit, an optional touch-up using up to 90 U of abobotulinumtoxinA can be performed. This will involve up to 18 injection sites, with each injection site receiving 0.025mL (5 U).

Drug: AbobotulinumtoxinA

180U abobotulinumtoxinA

ACTIVE COMPARATOR

Treatment of platysmal bands using a total of 180 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.0375mL (7.5 U). At the 14 day visit, an optional touch-up using up to 90 U of abobotulinumtoxinA can be performed. This will involve up to 12 injection sites, with each injection site receiving 0.0375mL (7.5 U).

Drug: AbobotulinumtoxinA

240U abobotulinumtoxinA

ACTIVE COMPARATOR

Treatment of platysmal bands using a total of 240 U abobotulinumtoxinA. This will involve 24 injection sites (6 injections per each of 4 platysmal bands), with each injection site receiving 0.05mL (10 U). At the 14 day visit, an optional touch-up using up to 120 U of abobotulinumtoxinA can be performed. This will involve up to 12 injection sites, with each injection site receiving 0.05mL (10 U).

Drug: AbobotulinumtoxinA

Interventions

AbobotulinumtoxinA DRUG

Injection of platysmal bands.

Also known as: Dysport

120U abobotulinumtoxinA; 180U abobotulinumtoxinA; 240U abobotulinumtoxinA

Eligibility Criteria

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

You may qualify if:

• Male or female, 18 to 65 years of age.
• Moderate to severe platysmal bands (grade 3 or 4 on the Photographic Platysma Bands Scale, which ranges from 1 \[minimal\] to 5 \[extreme\]) at rest and at maximum contraction as assessed by the Investigator Live Assessment (ILA).
• Females of non-childbearing potential (i.e., post-menopausal \[absence of menstrual bleeding for 1 year prior to screening, without any other medical reason\], or has undergone hysterectomy or bilateral oophorectomy) or
• Females 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. A highly effective method of contraception is defined as:
• Bilateral tubal ligation;
• Combined (estrogen and progesterone containing) oral, intravaginal or transdermal contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit;
• Intrauterine device (IUD) inserted at least 28 days prior to screening visit;
• Intrauterine hormone-releasing system;
• Partner vasectomized for at least three months prior to screening visit;
• Progestogen -only oral, injectable or implantable contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit; or prior to screening visit; or
• Strict abstinence (i.e., refraining from heterosexual intercourse for the entire duration of the subject's participation in the study).
• Time and ability to complete the study and comply with instructions.
• Understands the study requirements and signed the informed consent form (ICF).

You may not qualify if:

• Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or chest within 12 months prior to study treatment.
• Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
• Known hypersensitivity to any component of the study product, or allergy to cow's milk protein\* (according to the package insert/information).
• \*This criterion does not exclude subjects who are lactose intolerant. Lactose intolerance is a gastrointestinal disorder caused by an enzyme deficiency (lactase). An allergy to cow's milk protein is an immunological disorder that results in a systemic reaction, such as anaphylaxis.
• Known allergy or sensitivity to any botulinum toxin serotype.
• Female who is breast-feeding.
• Female who intends to conceive a child during the study.
• Current smoker of any kind (e.g., tobacco, cloves, marijuana, vape pens, hookah, etc.), and agrees not to smoke for the duration of the study.
• Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy to the lower face (i.e., below the level of the bottom of the nose), neck or chest within 12 months prior to study treatment.
• Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite, Poly-L-lactic acid, polymethyl methacrylate, etc.) facial tissue augmentation therapy, lifting sutures, permanent implants or autologous fat to the lower face (i.e., below the level of the bottom of the nose), neck or chest within 24 months prior to study treatment.
• History of lower face (i.e., below the level of the bottom of the nose), neck or chest surgery, aesthetic procedures (e.g. ablative skin resurfacing, laser, microneedling, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non- surgical fat reduction procedure) in the previous 12 months, or any other procedures which the Investigator's opinion would interfere with study evaluations.
• Planned surgery or aesthetic procedures to the lower face (i.e., below the level of the bottom of the nose), neck or chest (e.g. ablative skin resurfacing, laser, mesotherapy, Platelet-Rich Plasma (PRP) treatment, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non-surgical fat reduction procedure) during the study period.
• Clinically significant abnormal focused physical examination finding(s) at screening or baseline visits.
• History of clavicular or sternal fracture.
• Presence of inflammation, active infection or skin disorder, such as eczema, rosacea, psoriasis, pseudofolliculitis barbae, herpes zoster etc, near (i.e., superior to the clavicle and inferior to the mandible) or in the platysmal bands area.

Sponsors & Collaborators

• Clinical Testing of Beverly Hills: lead
• Galderma R&D: collaborator

Study Sites (1)

Clinical Testing of Beverly Hills

Encino, California, 91436, United States

Location

Related Publications (5)

• Monheit GD, Pickett A. AbobotulinumtoxinA: A 25-Year History. Aesthet Surg J. 2017 May 1;37(suppl_1):S4-S11. doi: 10.1093/asj/sjw284.

  PMID: 28388718 BACKGROUND

• Carruthers J, Carruthers A. The evolution of botulinum neurotoxin type A for cosmetic applications. J Cosmet Laser Ther. 2007 Sep;9(3):186-92. doi: 10.1080/14764170701411470.

  PMID: 17763029 BACKGROUND

• Matarasso A, Matarasso SL, Brandt FS, Bellman B. Botulinum A exotoxin for the management of platysma bands. Plast Reconstr Surg. 1999 Feb;103(2):645-52; discussion 653-5. doi: 10.1097/00006534-199902000-00043.

  PMID: 9950556 BACKGROUND

• Brandt FS, Bellman B. Cosmetic use of botulinum A exotoxin for the aging neck. Dermatol Surg. 1998 Nov;24(11):1232-4. doi: 10.1111/j.1524-4725.1998.tb04103.x.

  PMID: 9834744 BACKGROUND

• Kane MA. Nonsurgical treatment of platysmal bands with injection of botulinum toxin A. Plast Reconstr Surg. 1999 Feb;103(2):656-63; discussion 664-5. doi: 10.1097/00006534-199902000-00045.

  PMID: 9950557 BACKGROUND

MeSH Terms

Interventions

abobotulinumtoxinA

Study Officials

• John Joseph, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 13, 2021
• Study Start: May 30, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)