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

NCT01732809 | Completed Phase 4 Results

• 1 other identifier: 11-2011
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Wrinkling

Keywords

wrinkles; botulinum toxin; abobotulinumtoxinA; onabotulinumtoxinA; field of anhydrotic effects

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Wrinkle Severity Scale (WSS) at Maximum Contraction

  Baseline and 28 days

• Wrinkle Severity Scale (WSS) at Rest

  Baseline and 28 days

• Evoked Compound Muscle Action Potentials (ECMAP)

  Baseline and 28 days

Study Arms (2)

abobotulinumtoxin A

ACTIVE COMPARATOR

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)

onabotulinumtoxin A

ACTIVE COMPARATOR

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)

Interventions

AbobotulinumtoxinA (ABO) DRUG

Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.

Also known as: Dysport®

abobotulinumtoxin A

OnabotulinumtoxinA (ONA) DRUG

Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.

Also known as: Botox®

onabotulinumtoxin A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed consent
• Female subjects aged between 18 to 60 years
• Phototype I to IV
• Moderate to severe wrinkles in the forehead region on maximal contracture of the frontalis muscle according to the Wrinkle Severity Scale
• 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
• 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
• Negative urinary pregnancy test at the initial visit for women of childbearing potential
• 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
• Pregnancy or intention to become pregnant during the study period
• Breastfeeding
• Botulinum toxin treatments in the last 6 months
• Subjects participating in other clinical studies
• Any surgical procedure performed that has affected the frontal or orbicularis muscle, previous blepharoplasty or eyebrow raising
• Any cosmetic procedures, including fillers, or scars that may interfere with the results of the study
• Fronto-parietal alopecia according to the Norwood-Hamilton classification

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead

Study Sites (1)

Brazilian Center for Studies in Dermatology

Porto Alegre, Rio Grande do Sul, 90550-141, Brazil

Location

Related Publications (1)

• 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.

  PMID: 24108521 DERIVED

MeSH Terms

Interventions

abobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Scientific Coordinator
• Organization: Brazilian Center for Studies in Dermatology

cientifico@cbed.org.br

+55 51 30262633

Study Officials

• Doris M Hexsel, MD

  Brazilian Center for Studies in Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 26, 2012
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-11

Locations

BR (1)