Safety and Efficacy Study of Dysport RU and Glabellar Lines

Ipsen

Status and phase: Completed; Phase 2

Conditions: Glabellar Frown Lines

Treatments: Biological: Botulinum toxin type A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01333397

Y-52-52120-146

2010-019085-82 (EudraCT Number)

Details and patient eligibility

About

The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.

Enrollment: 176 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female between 30 - 60 years of age
• Moderate to severe vertical glabellar lines at maximum frown at baseline

Exclusion criteria

• Silicone injections into the upper face
• Any prior treatment with fillers (e.g. collagen-type implants) skin abrasions or photorejuvenation within the previous 12 months
• Any planned facial cosmetic surgery during the study period
• A history of ablative skin resurfacing of the area to be treated during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

176 participants in 5 patient groups, including a placebo group

Dysport RU 20 U

Experimental group

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Dysport RU 50 U

Experimental group

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Dysport RU 75 U

Experimental group

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Dysport (Azzalure) 50 U

Active Comparator group

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo