A Double-Blind Comparison of the Safety and Efficacy of Dysport® and BOTOX® (Botulinum Toxin Type A) in the Treatment of Female Subjects with Severe Glabellar Rhytids

Phase 1

• Conditions: Severe glabellar rhytids

• Registration Number: EUCTR2005-005235-96-GB
• Lead Sponsor: Cranley Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

-Female subjects of any race, between 30 and 50 years of age
-Glabellar rhytids
-Able to understand the requirements of the study and sign Informed Consent and Photography Release forms

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnant, or planning to become pregnant during the study period, have an infant they are breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
-Planned facial cosmetic procedure during the study period or with prior cosmetic procedures or visible scars
-Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytids
-Have had previous cosmetic surgery to the upper face
-Laser resurfacing, dermabrasion, or soft tissue augmentation in the frontal glabellar periocular area in the 12 months preceding Visit 1
-Any medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
-Current use of aminoglycoside antibiotics, curare-like agents, or agents 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
-Allergy or sensitivity to any component of the study medication
-Have had previous botulinum toxin therapy of any serotype for any reason within 6 months of the Baseline/Screening Visit
-Alcohol or drug abuse is evident
-Medical and/or psychiatric problems interfering with the study results
-History of poor cooperation, non-compliance with medical treatment, or unreliability
-Current participation in an investigational drug study or having participated in an investigational drug study within 30 days of the Baseline Visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the safety and efficacy of 75U Dysport® to 30U BOTOX® in the treatment of subjects with severe glabellar rhytids.;Secondary Objective: N/A;<br> Primary end point(s): – Primary end point: Qualitative Rating of Glabellar Rhytids<br> – Other end points:<br> 1) Brow Position<br> 2) Subject Self-Evaluation Form<br> 3) FLO Questionnaire<br> 4) Facial Wrinkle Scale<br> 5) Injection Pain<br>