Text Size

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:
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT01732809
First received: November 7, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Botox
U.S. FDA Resources

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

Primary Outcome Measures:
  • Field effect [ Time Frame: 1 time ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 60 Years
Genders 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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Doris Hexsel, MD, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier: NCT01732809     History of Changes
Other Study ID Numbers: 11-2011
Study First Received: November 7, 2012
Last Updated: November 28, 2012
Health Authority: Brazil: Local Ethic Committee

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

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013