Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines
NCT ID: NCT05083286
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
40 participants
INTERVENTIONAL
2021-10-20
2022-08-01
Brief Summary
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Detailed Description
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The total BOTOX dose will be 20U divided into 5 injections for both study groups. However, the injection volume will differ for the two study groups, such that the OLD (4 U per 0.1 mL) group will receive a total of 0.5 mL and the COLD (4 U per 0.02 mL) group will receive a total of 0.1mL.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OLD (4 U per 0.1 mL)
The total BOTOX dose will be 20U divided into 5 injections. Each injection will receive a total of 0.5 mL.
OnabotulinumtoxinA
Injection of glabellar rhytids
COLD (4 U per 0.02 mL group)
The total BOTOX dose will be 20U divided into 5 injections. Each injection will receive a total of 0.1 mL.
OnabotulinumtoxinA
Injection of glabellar rhytids
Interventions
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OnabotulinumtoxinA
Injection of glabellar rhytids
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Facial Wrinkle Scale.
* 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.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.
* 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
Exclusion Criteria
* 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.
* Known allergy or sensitivity to the study treatment or its components.
* Known immunization or hypersensitivity to any botulinum toxin serotype.
* Prior exposure to or anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment).
* Evidence of recent alcohol or drug abuse.
* The subject has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
18 Years
FEMALE
Yes
Sponsors
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Allergan
INDUSTRY
Clinical Testing of Beverly Hills
OTHER
Responsible Party
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Principal Investigators
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John Joseph, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Testing of Beverly Hills
Locations
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Clinical Testing of Beverly Hills
Encino, California, United States
Steve Yoelin MD
Newport Beach, California, United States
Countries
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Central Contacts
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Facility Contacts
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Mary Hayes
Role: primary
Steve Yoelin, MD
Role: primary
References
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Blitzer A, Binder WJ, Aviv JE, Keen MS, Brin MF. The management of hyperfunctional facial lines with botulinum toxin. A collaborative study of 210 injection sites in 162 patients. Arch Otolaryngol Head Neck Surg. 1997 Apr;123(4):389-92. doi: 10.1001/archoto.123.4.389.
Carruthers A, Carruthers J, Said S. Dose-ranging study of botulinum toxin type A in the treatment of glabellar rhytids in females. Dermatol Surg. 2005 Apr;31(4):414-22; discussion 422. doi: 10.1111/j.1524-4725.2005.31107.
Carruthers JA, Lowe NJ, Menter MA, Gibson J, Nordquist M, Mordaunt J, Walker P, Eadie N; BOTOX Glabellar Lines I Study Group. A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2002 Jun;46(6):840-9. doi: 10.1067/mjd.2002.121356.
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.
Other Identifiers
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CTBH-005
Identifier Type: -
Identifier Source: org_study_id