Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines

Completed · Phase 2

Conditions studied: Frown Lines

In brief

The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations.

Key facts

Study ID

NCT04763265

Run by

Croma-Pharma GmbH

People needed

208

Starts

2020-06-24

Expected to finish

2021-02-01

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to Screening, or any planned treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational treatment).
• Known hypersensitivity to either study medication or its excipients.
• Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy.
• Facial laser or light treatment, microdermabrasion, superficial peels or retinoid therapy within the three months prior to Screening or planned during the study.
• o Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers, photo rejuvenation) within 12 months prior to Screening or planned during the study.
• Previous insertion of permanent material in the glabellar area, or planned insertion during the study.
• Any planned or history of surgery in the glabellar area and/or canthal line area, or scars in the glabellar and/or canthal line.
• Active skin disease/infection or irritation at the treatment area.
• Inability to substantially lessen glabellar frown lines and or lateral canthal lines even by physically spreading them apart.
• Use of a muscle relaxant within 2 weeks prior to Screening, or planned use during the study.
• Marked facial asymmetry or ptosis of eyelid and/or eyebrow, or current facial palsy or neuromuscular junction disorders as judged by the investigator.
• Pregnant, breastfeeding or planning to become pregnant during the study.
• Use of prohibited medication including anticholinergic drugs, or drugs which could interfere with neuromuscular function, including aminoglycoside antibiotics and curare-like compounds within 2 weeks prior to Screening or planned during the study.
• Planned surgery with general anesthetic (use of local anesthetic outside the glabellar area is permitted).
• Participation in another clinical study within one month of Screening and throughout the study.
• Previous participation in another botulinum toxin aesthetic study, which involved the treatment of glabellar, lines in combination with canthal lines and/or forehead lines in the previous 18 months.
• Chronic drug or alcohol abuse (as per investigator discretion).

Where it is running

• ATS Clinical Research — Santa Monica, California, United States
• Skin Research Institute LLC — Coral Gables, Florida, United States
• Monika Sulovsky — Vienna, Austria
• Institute Of Cosmetic — Oakville, Ontario, Canada
• Sweat Clinics of Canada — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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