Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study I

Completed · Phase 3 · Has a placebo group

Conditions studied: Glabellar Frown Lines

In brief

The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of glabellar lines in comparison with placebo, including efficacy after repeat treatments and long term safety.

Key facts

Study ID

NCT02677298

Run by

Croma-Pharma GmbH

People needed

784

Starts

2016-03-02

Expected to finish

2017-11-16

Last updated by the study team

2025-03-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged ≥ 18 years or older at the time of screening (upper limit 75 years, inclusive).
• Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on FWS) as determined by in-clinic assessments by both the investigator and the subject (where: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe').
• Subject has a stable medical condition with no uncontrolled systemic disease.
• Female subjects of childbearing potential must test negative for pregnancy and agree to use highly effective birth control during the course of the study. Such methods include for example: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion or vasectomized partner.
• Subjects who wear glasses must be able to adequately self-assess the severity of their glabellar lines (according to the FWS), without glasses obstructing the forehead area.
• The moderate to severe glabellar lines have an important psychological impact on the subject, as indicated by scores >0 on either the Emotional or Functioning subscales of the modified Skindex-16 (GL-QoL).

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 trial (other than the investigational treatment).
• Known hypersensitivity to the 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 3 months prior to screening or planned during the study.
• Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers,) within 12 months prior to screening or planned during the study.
• Previous insertion of permanent material in the glabellar area or planned during the study.
• Any surgery, or history of surgery, in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these, or scars in the glabellar area, or such surgery planned during the study.
• Active skin disease/infection or irritation at the treatment area.
• Inability to substantially lessen glabellar frown lines even by physically spreading them apart.
• Use of a muscle relaxant within 2 weeks prior to screening or planned 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 trial.
• 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 anaesthetic (use of local anaesthetic outside the glabellar area is permitted).
• Participation in another clinical study within one month of screening and throughout the trial.
• 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).
• Eligibility Criteria for re-treatment: The following criteria MUST be met for re-treatment:
• At time of re-treatment subject does not have relevant changes to their health status from enrollment, which would have prevented subject's entry into the study according to the inclusion and exclusion criteria
• The subject must have been randomized to receive treatment and must have received at least one treatment (BoNT/A-DP or placebo).
• A minimum of 12 weeks must have elapsed since the previous study treatment.
• The subject's glabellar lines at maximum frown must have relapsed to a FWS score of 2 or 3 as determined by the investigator and the subject.
• No relevant infection or inflammation in the planned injection area.
• Negative urine pregnancy test, in women of child-bearing potential.
• The subject must have received fewer than four study treatments.

Where it is running

• Total Skin And Beauty Dermatology Center, Pc — Birmingham, Alabama, United States
• Clinical Testing of Beverly Hills — Encino, California, United States
• Maas Clinic — San Francisco, California, United States
• About Skin — Greenwood Village, Colorado, United States
• DeNova Research — Chicago, Illinois, United States
• Skin Specialists — Omaha, Nebraska, United States
• Aesthetic Solutions — Chapel Hill, North Carolina, United States
• Society Hill Dermatology — Philadelphia, Pennsylvania, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• Praxisklinik Fur Dermatologie, Hautzentrum am Starnberger See — Starnberg, Bavaria, Germany
• Rosenpark Research — Darmstadt, Hesse, Germany
• RZANY & HUND, Privatpraxis — Berlin, Germany
• S-thetic Clinic Hamburg — Hamburg, Germany
• Praxis Klinik Dr. Med. Anita Ruetter — Münster, Germany
• Carpe Diem, Centre for Aesthetic Medicine — Warsaw, Poland
• Clinical Research Group Sp. z o.o. — Warsaw, Poland
• Estederm Dr Marcin Ambroziak — Warsaw, Poland
• High-Med. Przychodnia Specjalistyczna — Warsaw, Poland

Full record on ClinicalTrials.gov

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