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Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses (ABO ONA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732809
First Posted: November 26, 2012
Last Update Posted: November 29, 2012
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.
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology
  Purpose
The purpose of this study is to assess the fields of effect (FE) of ABO and ONA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activity.

Condition Intervention Phase
Healthy Subjects, Only With Wrinkles on Forehead. Drug: group A Drug: group B Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: FIELDS OF EFFECTS OF TWO COMMERCIAL PREPARATIONS OF BOTULINUM TOXIN TYPE A AT EQUAL LABELED UNIT DOSES

Resource links provided by NLM:


Further study details as provided by Doris Hexsel, Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:
  • Field effect [ Time Frame: 1 time ]
    Field effect characteristics of ABO and ONA at the same dose (1:1 labeled unit equivalence) regarding both muscle and sweat gland activities.


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group A
Group A: Patients received 2units/0.02 mL of reconstituted ABO on the right side of the forehead and 2 units/0.02 mL of reconstituted ONA on the left side.
Drug: group A
isovolumetric (0.02 mL) doses of 2 units of ABO injected on one side of the forehead and 2 units of ONA injected on the contralateral side
Other Names:
  • Dysport® (AbotulinumtoxinA; ABO),
  • Botox® (OnabotulinumtoxinA; ONA)
Active Comparator: group B
Patients received 2units/0.02 mL of reconstituted ABO on the left side of the forehead and 2 units/0.02 mL of reconstituted ONA on the right side.
Drug: group B
Patients received 2units/0.02 mL of reconstituted ABO on the left side of the forehead and 2 units/0.02 mL of reconstituted ONA on the right side.
Other Names:
  • Dysport® (AbotulinumtoxinA; ABO),
  • Botox® (OnabotulinumtoxinA; ONA)

Detailed Description:
This is a prospective, single-center, randomized, double-blind study. All participants will be recruited from a research center in Porto Alegre, Brazil, and provided written informed consent. This study will be approved by the local Ethics Committee of Associação Hospitalar Moinhos de Vento and all Good Clinical Practices, Declaration of Helsinki protocols and national regulations were followed. The main inclusion criteria are: female subjects aged between 18 to 60 years; presence of moderate to severe forehead wrinkles on both sides at maximum contraction of frontalis muscle according to Wrinkle Severity Scores (WSS) (Hexsel et al., 2012); positive sweating by the Minor's Test (Minor, 1927) and scores from III to V on the Sweat Intensity Visual Scale (Hexsel et al., 2010).
  Eligibility

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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:

  • female subjects aged between 18 to 60 years;
  • presence of moderate to severe forehead wrinkles on both sides at maximum contraction of frontalis muscle according to Wrinkle Severity Scores (WSS) (Hexsel et al., 2012);
  • positive sweating by the Minor's Test (Minor, 1927) and scores from III to V on the Sweat Intensity Visual Scale (Hexsel et al., 2010).

Exclusion Criteria:

  Contacts and Locations
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
Brazil
CBED
Porto Alegre, Brazil
Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
Investigators
Principal Investigator: Doris m Hexsel, MD CBED
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Doris Hexsel, MD, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier: NCT01732809     History of Changes
Other Study ID Numbers: 11-2011
First Submitted: November 7, 2012
First Posted: November 26, 2012
Last Update Posted: November 29, 2012
Last Verified: November 2012

Keywords provided by Doris Hexsel, Brazilan Center for Studies in Dermatology:
wrinkles
botulinum toxin

Additional relevant MeSH terms:
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents