Sponsor study identifier
interventional
19
1 country
1
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2011
Actual (reported)Study Completion
November 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 2011
Actual (reported)November 2011
Actual (reported)November 7, 2012
Actual (reported)November 26, 2012
Actual (reported)December 17, 2020
Actual (reported)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.
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
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.
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.
Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.
Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, 90550-141, Brazil
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.
Doris M Hexsel, MD
Brazilian Center for Studies in Dermatology
19 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2012
First Posted
November 26, 2012
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
28 days
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Primary Completion
November 2011
Actual (reported)Study Completion
November 2011
Actual (reported)Last Updated
December 17, 2020
Results First Posted
December 17, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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