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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732809
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology

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.

Condition or disease Intervention/treatment Phase
Skin Wrinkling Drug: AbobotulinumtoxinA (ABO) Drug: OnabotulinumtoxinA (ONA) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Fields of Effects of Two Commercial Preparations of Botulinum Toxin Type A at Equal Labeled Unit Doses
Study Start Date : January 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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 Name: 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 Name: Botox®




Primary Outcome Measures :
  1. Horizontal Diameter of the Fields of Anhidrotic Effect [ Time Frame: 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.


  2. Vertical Diameter of the Fields of Anhidrotic Effect [ Time Frame: 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.


  3. Area of the Fields of Anhidrotic Effect [ Time Frame: 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.



Secondary Outcome Measures :
  1. Wrinkle Severity Scale (WSS) at Maximum Contraction [ Time Frame: Baseline and 28 days ]

    It is a 4-point validated scale for forehead lines:

    0 - None

    1. - Mild
    2. - Moderate
    3. - 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.


  2. Wrinkle Severity Scale (WSS) at Rest [ Time Frame: Baseline and 28 days ]

    It its a 4-point validated scale for forehead lines:

    0 - None

    1. - Mild
    2. - Moderate
    3. - 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.


  3. Evoked Compound Muscle Action Potentials (ECMAP) [ Time Frame: Baseline and 28 days ]

    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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732809


Locations
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Brazil
Brazilian Center for Studies in Dermatology
Porto Alegre, RS, Brazil, 90550-141
Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
Investigators
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Principal Investigator: Doris M Hexsel, MD Brazilian Center for Studies in Dermatology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Doris Hexsel, MD, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier: NCT01732809    
Other Study ID Numbers: 11-2011
First Posted: November 26, 2012    Key Record Dates
Results First Posted: December 17, 2020
Last Update Posted: December 17, 2020
Last Verified: November 2020
Keywords provided by Doris Hexsel, Brazilan Center for Studies in Dermatology:
wrinkles
botulinum toxin
abobotulinumtoxinA
onabotulinumtoxinA
field of anhydrotic effects
Additional relevant MeSH terms:
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Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents