Who is sponsoring NCT01732809?

NCT01732809 is sponsored by Hexsel Dermatology Clinic.

What condition does NCT01732809 study?

NCT01732809 studies Skin Wrinkling.

What drugs are being tested in NCT01732809?

Interventions: AbobotulinumtoxinA (ABO), OnabotulinumtoxinA (ONA).

What is the status of NCT01732809?

NCT01732809 is currently COMPLETED.

Last reviewed 2020-11-23 · How we verify

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

NCT01732809 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Hexsel Dermatology Clinic
Phase	Phase 4
Status	COMPLETED
Enrolment	19
Start date	2011-01
Completion	2011-11

Conditions

Skin Wrinkling

Interventions

AbobotulinumtoxinA (ABO)
OnabotulinumtoxinA (ONA)

Primary outcomes

Horizontal Diameter of the Fields of Anhidrotic Effect — 28 days
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.
Vertical Diameter of the Fields of Anhidrotic Effect — 28 days
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.
Area of the Fields of Anhidrotic Effect — 28 days
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.

Countries

Brazil