Xeomin Treatment of Glabellar Lines Using OLD Versus COLD

NCT05305768 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: CTBH-02-2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Xeomin in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.

Conditions

Glabellar Frown Lines

Keywords

wrinkles; incobotulinumtoxinA

Outcome Measures

Primary Outcomes (1)

• Response Duration

  Time to return to baseline Facial Wrinkle Scale (FWS) score at maximum frown, as assessed by the blinded evaluating investigator. The Facial Wrinkle Scale (FWS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.

  180 days

Secondary Outcomes (6)

• Investigator Live Assessment (Dynamic)

  180 days

• Subject Self Assessment (Dynamic)

  180 days

• Investigator Live Assessment (At Rest)

  180 days

• Subject Self Assessment (At Rest)

  180 days

• Change from Baseline Score

  180 days

Study Arms (2)

OLD (4 U per 0.1 mL)

ACTIVE COMPARATOR

Participants will receive a total Xeomin dose of 20U using a 4U per 0.1mL concentration divided into 5 intramuscular injections performed once.

Drug: IncobotulinumtoxinA

COLD (4 U per 0.05 mL group)

ACTIVE COMPARATOR

Participants will receive a total Xeomin dose of 20U using a 4U per 0.05mL concentration divided into 5 intramuscular injections performed once.

Drug: IncobotulinumtoxinA

Interventions

IncobotulinumtoxinA DRUG

Injection of glabellar rhytids

Also known as: Xeomin

COLD (4 U per 0.05 mL group); OLD (4 U per 0.1 mL)

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age at the time of signing the informed consent.
• Overtly healthy as determined by medical evaluation (includes: medical history, physical examination, and vital signs).
• Subjects have moderate or severe dynamic glabellar lines on maximum frown as assessed with the Merz FWS with photonumeric guide.
• Female sex.
• Female subjects willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. A female subject is eligible to participate if she is not pregnant (has a negative urine pregnancy result at Day 1 prior to treatment), is not breastfeeding, and at least one of the following conditions applies: 1)Not a female of childbearing potential OR 2) A female of childbearing potential who agrees to follow the contraceptive guidance in Appendix 4 during the study.
• Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Written informed consent from the subject has been obtained prior to any study-related procedures.
• Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information)
• Able, as assessed by the blinded evaluating investigator, and willing to follow study instructions and likely to complete all required study visits

You may not qualify if:

• Brow or eyelid ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytides, even by physically spreading them apart.
• Facial asymmetry including, in the opinion of the investigator, significant asymmetry with active contraction or at rest of the frontalis muscle.
• Medical condition that may increase the subject's risk of exposure to botulinum toxin, including diagnosed myasthenia gravis, Lambert-Eaton Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
• Profound atrophy/excessive weakness of muscles in target areas of injection.
• History of facial nerve palsy.
• Infection at the injection site or systemic infection.
• Presence of inflammation at the proposed injection site.
• Previous cosmetic surgery to the upper face (eg, periorbital surgery, brow lift, eyelid or eyebrow surgery), tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers, or planning a facial cosmetic procedure during the study period.
• Subjects have been treated in the upper face (forehead lines, glabellar lines, crow's feet lines) within 1 year prior to the Baseline/Day 1 Visit with botulinum toxin therapy of any serotype.
• Noncompliance with the proper washout periods for prohibited medications/procedures.
• Subjects on topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 6 months prior to enrollment and who are unable to maintain a consistent dose regimen during the study.
• Oral retinoid therapy within 1 year prior to study enrollment.
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
• Females who are pregnant, breastfeeding, or planning a pregnancy during the study
• Females of childbearing potential not using a reliable means of contraception.

Sponsors & Collaborators

• Clinical Testing of Beverly Hills: lead
• Merz North America, Inc.: collaborator

Study Sites (2)

Clinical Testing of Beverly Hills

Encino, California, 91436, United States

Location

Alexander Rivkin MD

Los Angeles, California, 90025, United States

Location

Related Publications (2)

• Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3.

  PMID: 15507786 BACKGROUND

• Prager W, Bee EK, Havermann I, Zschocke I. Onset, longevity, and patient satisfaction with incobotulinumtoxinA for the treatment of glabellar frown lines: a single-arm, prospective clinical study. Clin Interv Aging. 2013;8:449-56. doi: 10.2147/CIA.S34854. Epub 2013 Apr 24.

  PMID: 23650444 BACKGROUND

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

• John Joseph, MD

  Clinical Testing of Beverly Hills

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Hayes

CONTACT

747-998-5160; mary@clinicaltestingcenter.com

John Joseph, MD

CONTACT

8186163880; drjohnjoseph@sbcglobal.net

Study Design

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

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: March 31, 2022
• Study Start: May 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)