Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses

Fields of Effects of Two Commercial Preparations of Botulinum Toxin Type A at Equal Labeled Unit Doses

The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activity.

Study Overview

• Status: Completed
• Conditions: Skin Wrinkling
• Intervention / Treatment: Drug: AbobotulinumtoxinA (ABO); Drug: OnabotulinumtoxinA (ONA)

Detailed Description

This is a prospective, single-center, randomized, double-blind study. All participants were recruited from a research center in Porto Alegre, Brazil, and provided written informed consent. The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activities. Nineteen patients were enrolled and evaluations were performed at baseline and 28 days after treatment.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90550-141
      • Brazilian Center For Studies in Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Signed consent
2. Female subjects aged between 18 to 60 years
3. Phototype I to IV
4. Moderate to severe wrinkles in the forehead region on maximal contracture of the frontalis muscle according to the Wrinkle Severity Scale
5. Subjects with the Minor Test* considered positive from grade 3 to 5 on the Minor test sweat intensity scale, showing sweat on the forehead under standardized conditions
6. Medical history and clinical examination that, in the investigator's opinion, do not prevent the subject from participating in the study or from using the proposed medication
7. Negative urinary pregnancy test at the initial visit for women of childbearing potential
8. Use of an effective contraceptive method (oral or injectable contraception, abstinence, intrauterine device, diaphragm, hysterectomy or bilateral ovariectomy, tubal attachment, condom, sponge, spermicide or partner with vasectomy) throughout the study for women of childbearing potential
9. Subjects must agree not to undergo other dermatological or aesthetic treatments during the study period *The Minor test must be the last test to be done. Only the subjects who fulfill all the inclusion criteria above undergo the Minor test to check for sweating in the frontal region. The graduation considered positive for inclusion in the study will be 3 to 5.

Inclusion Criteria:

1. Pregnancy or intention to become pregnant during the study period
2. Breastfeeding
3. Botulinum toxin treatments in the last 6 months
4. Subjects participating in other clinical studies
5. Any surgical procedure performed that has affected the frontal or orbicularis muscle, previous blepharoplasty or eyebrow raising
6. Any cosmetic procedures, including fillers, or scars that may interfere with the results of the study
7. Fronto-parietal alopecia according to the Norwood-Hamilton classification
8. Neoplastic, muscular or neurological diseases
9. Use of using aminoglycoside antibiotics or penicillamines, quinine or calcium channel blockers or that they will use at any time during the study
10. Inflammatory or infectious processes at the application site
11. Evident facial asymmetry
12. History of adverse event, such as sensitivity to the components of the formula, ptosis or any other adverse event that, in the investigator's opinion, prevents the research subject from participating in the study
13. Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron disease
14. Coagulation disorders or use of anticoagulants
15. Autoimmune disease
16. History of poor adherence to treatments or who have shown lack of cooperation to adhere to the study protocol
17. Any condition that, in the investigator's opinion, could compromise the results of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: abobotulinumtoxin A; Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received abobotulinumtoxin A in one of the sides of the forehead.	Drug: AbobotulinumtoxinA (ABO); Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.; Other Names: Dysport®
Active Comparator: onabotulinumtoxin A; Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received onabotulinumtoxin A in one of the sides of the forehead.	Drug: OnabotulinumtoxinA (ONA); Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.; Other Names: Botox®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal Diameter of the Fields of Anhidrotic Effect	The Horizontal Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.	28 days
Vertical Diameter of the Fields of Anhidrotic Effect	The Vertical Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.	28 days
Area of the Fields of Anhidrotic Effect	The area of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Severity Scale (WSS) at Maximum Contraction	It is a 4-point validated scale for forehead lines: 0 - None; - Mild; - Moderate; - Severe The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.	Baseline and 28 days
Wrinkle Severity Scale (WSS) at Rest	It its a 4-point validated scale for forehead lines: 0 - None; - Mild; - Moderate; - Severe The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.	Baseline and 28 days
Evoked Compound Muscle Action Potentials (ECMAP)	Amplitude of the evoked compound muscle action potentials in the frontalis muscle on stimulation of the facial nerve performed at baseline and visit 2 using surface electrodes on the forehead and electrical stimulation of the facial nerve according to standard neurophysiologic procedures. The amplitude of the ECMAP was performed by an experienced neurologist using an electromyography device (Teca Sapphire; Teca Corp).	Baseline and 28 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Hexsel D, Hexsel C, Siega C, Schilling-Souza J, Rotta FT, Rodrigues TC. Fields of effects of 2 commercial preparations of botulinum toxin type A at equal labeled unit doses: a double-blind randomized trial. JAMA Dermatol. 2013 Dec;149(12):1386-91. doi: 10.1001/jamadermatol.2013.6440.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 19, 2012
• First Posted (Estimate): November 26, 2012

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: wrinkles; botulinum toxin; abobotulinumtoxinA; onabotulinumtoxinA; field of anhydrotic effects
• 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, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 11-2011