Comparison of Two Commercial Preparations of Botulinum Toxin Type A

This study has been completed.
Sponsor:
Information provided by:
Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT00959907
First received: April 23, 2009
Last updated: December 9, 2009
Last verified: November 2009
  Purpose

The objective of this study is to compare the action halos of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.


Condition Intervention Phase
Wrinkles in Frontal Area
Drug: BOTULINUM TOXIN TYPE-A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase iv Controlled Randomized Blinded Study on the Anhydrotic Action Halos and Muscle Activity of Two Commercial Preparations Type a Botulinum Toxin (Dysport® and Botox® ) Administered to the Upper Third of the Face

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Horizontal Action Halo Diameter at 28 Days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • ECMAP in m. Frontialis BoNT A1(4U) X BoNT A2 (2U) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Horizontal Action Halo Diameter at 112 Days [ Time Frame: 112 days ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: May 2005
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BoNT A1 (4U)
BoNT A1 (4U): Botulinum toxin A (Dysport®)4 units
Drug: BOTULINUM TOXIN TYPE-A

On Visit 1 (Day 0):

Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.

  • Dysport®: 4 units will be injected in the left or right forehead side.
  • Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)
Other Names:
  • BoNT A1 = Dysport
  • BoNT A2 = Botox
Active Comparator: BoNT-A2 (2U)
BoNT-A2(2U): Botulinum toxin A (Botox®) 2 units
Drug: BOTULINUM TOXIN TYPE-A

On Visit 1 (Day 0):

Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site.

  • Dysport®: 4 units will be injected in the left or right forehead side.
  • Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)
Other Names:
  • BoNT A1 = Dysport
  • BoNT A2 = Botox

Detailed Description:

This was a monocentric, prospective, randomized and double-blind study. Fifty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. There were two randomizations, one related to the dose-equivalence (2:1U and 2.5:1U), both reconstituted in the same volume of 0.02 mL per point and another related to the forehead side (left or right) for application of the tested drugs. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Written Informed Consent (Annex 1)
  2. Female
  3. Subjects agreeing to take part in all procedures of the study, including botulinum toxin applications, Minor's test, measurement of Evoked Potentials, photographs, etc.), after being fully informed on the objectives and nature of the investigations
  4. Subjects aged between 18 and 60 years
  5. Subjects presenting with moderate to severe wrinkles on the forehead under maximum voluntary contraction of the m. frontalis
  6. Subjects with positive Minor's test showing sweating on the forehead in standardized conditions described in Annex 2

    *The Minor's Test will be the last inclusion criterion to be evaluated. Only these patients eligible according to the other inclusion criteria will undergo the Minor's Test to evaluate their sweating on the forehead. The cut off point is a positive Minor's Test (Level +1) - only subjects with Minor's Test (Level +1) will be recruited in the study (Annex 2).

  7. Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the products under investigation
  8. Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using an effective contraceptive method;
  9. Availability of the patient throughout the duration of the study (112 days)
  10. Subject agrees not to undergo other cosmetic or dermatological procedures during the study
  11. Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol

Exclusion Criteria:

  1. Pregnant women or women intending to become pregnant in the next 4 months after screening for eligibility
  2. Subjects who are lactating
  3. Subjects having undergone botulinum toxin treatment within the last 6 months
  4. Subjects participating in other clinical trials
  5. Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharoplasty or brow lift
  6. Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results
  7. Subjects presenting fronto-parietal alopecia according to the Norwood-Hamilton classification
  8. Subjects with neoplastic, muscular or neurological diseases
  9. Subjects using aminoglycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers
  10. Subjects with inflammation or active infection in the area to be injected
  11. Subjects presenting evident facial asymmetry
  12. Subjects with a history of adverse effects, such as sensitivity to the components of the formula, ptosis or any other adverse effect, which in the investigator's opinion should prevent the patient from participating in the study
  13. Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron diseases
  14. Subjects with coagulation disorders or using anticoagulants
  15. Subjects with known systemic autoimmune diseases
  16. Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol
  17. Any condition that, in the opinion of the investigator, can compromise the evaluation of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959907

Locations
Brazil
Brazilian Center for Dermatological Studies
Porto Alegre, Rio Grande do Sul, Brazil, 90570-040
Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
Investigators
Principal Investigator: Doris Hexsel, MD
  More Information

No publications provided

Responsible Party: Doris Hexsel, CBED
ClinicalTrials.gov Identifier: NCT00959907     History of Changes
Other Study ID Numbers: 01-CBED06
Study First Received: April 23, 2009
Results First Received: April 23, 2009
Last Updated: December 9, 2009
Health Authority: Brazil: Ministry of Health

Keywords provided by Brazilan Center for Studies in Dermatology:
Muscular activity
wrinkles in frontal area
action halos

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 September 14, 2014