Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum

Phase IV, Randomized, Double-blind Study on Muscle Activity of Two Commercial Preparations of Botulinum Toxin Type A (Dysport and Xeomin) Administered to the Upper Third of the Face (Forehead Lines).

this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin).

Study Overview

• Status: Completed
• Conditions: Sun-induced Wrinkles
• Intervention / Treatment: Drug: Dysport; Drug: Xeomin

Detailed Description

Subjects will perform 6 (six) visits during the study:

Screening visit, performed 30 to 1 day before the visit 1, when eligible subjects will be recruited and first evaluations will be performed; visit 1, which is the baseline and when the injections will be performed; visit 2, 30 +/- 3 days after the injections, when evaluations will be performed; visit 3, 90 +/- 3 days after the injections, when evaluations will be performed; 4, 120 +/- 3 days after the injections, when evaluations will be performed; visit 5, 150 +/- 3 days after the injections, when evaluations will be performed.

Assessment of percentage (%) of responders, after 5 months of injection, to the effects of two BT-A preparations, Dysport® and Xeomin®, by measuring frontalis m. wrinkle intensity at maximum contraction, as measured by visual Wrinkles Severity Scale (WSS).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil
      • Brazilian Center For Studies in Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
• Female subjects;
• Phototype I to IV;
• Subjects aged between 18 and 60 years;
• Subjects naive for BT-A treatment;
• Subjects presenting the same degree of moderate (2) to severe (3) wrinkles on the left and right side of forehead under maximum voluntary contraction of the frontalis m. according WSS;
• Subjects with Minor's test showing at least grade III in the Sweating Intensity Visual Scale;
• Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation;
• Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study;
• Availability of the subject throughout the study (5 months);
• Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study;
• Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol.

Exclusion Criteria:

• Pregnant women or women intending to become pregnant in the following 5 months after screening;
• Lactation period;
• Subjects participating in other clinical trials;
• Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharoplasty or brow lift;
• Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results;
• Subjects with neoplastic, muscular or neurological diseases;
• Subjects taking aminoglycoside and penicillamine antibiotics, quinine or Ca2+ channel blockers;
• Subjects with inflammation or active infection in the area to be injected;
• Subjects presenting evident facial asymmetry;
• Subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula, ptosis or any other adverse effect which, in the investigator's opinion, should prevent the subject from participating in the study;
• Subjects presenting Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron disease;
• Subjects with coagulation disorders or taking anticoagulants;
• Subjects with known systemic autoimmune diseases;
• Subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol;
• Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Dysport and Xeomin; 30 U of Dysport® was injected on the right side of the forehead and 12 U Xeomin® was injected on the left side of the forehead (dose-equivalence 2.5:1).	Drug: Dysport; Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.; Other Names: botulinum toxin type A; Drug: Xeomin; Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead; Other Names: botulinum toxin type A
ACTIVE_COMPARATOR: Xeomin and Dysport; 30 U Dysport® was injected on the left side of the forehead and 12 U Xeomin® was injected on the right side of the forehead (dose-equivalence 2.5:1).	Drug: Dysport; Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.; Other Names: botulinum toxin type A; Drug: Xeomin; Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead; Other Names: botulinum toxin type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders After 5 Months After the Procedure	Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline. WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles.	5 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Evoked Compound Muscle Action Potential	To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.	5 months after the procedure.

Collaborators and Investigators

• Sponsor: Brazilan Center for Studies in Dermatology
• Investigators: Principal Investigator: Doris Hexsel, MD, Brazilian Center for Dermatologic Studies

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (ESTIMATE): November 19, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: wrinkles; botulinum toxin,
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 12-2012