Comparison of Two Commercial Preparations of Botulinum Toxin Type A

NCT00959907 | Completed Phase 4 Results

• 1 other identifier: 01-CBED06
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wrinkles in Frontal Area

Keywords

Muscular activity; wrinkles in frontal area; action halos

Outcome Measures

Primary Outcomes (3)

• Horizontal Action Halo Diameter at 28 Days

  Minor's test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.

  28 days

• ECMAP in m. Frontialis BoNT A1(4U) X BoNT A2 (2U)

  ECMAP(Evoked Compound Muscle Action Potentials) was accessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).

  28 days

• Horizontal Action Halo Diameter at 112 Days

  Minor's test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.

  112 days

Study Arms (2)

BoNT A1 (4U)

ACTIVE COMPARATOR

BoNT A1 (4U): Botulinum toxin A (Dysport®)4 units

Drug: BOTULINUM TOXIN TYPE-A

BoNT-A2 (2U)

ACTIVE COMPARATOR

BoNT-A2(2U): Botulinum toxin A (Botox®) 2 units

Drug: BOTULINUM TOXIN TYPE-A

Interventions

BOTULINUM TOXIN TYPE-A DRUG

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)

Also known as: BoNT A1 = Dysport, BoNT A2 = Botox

BoNT A1 (4U); BoNT-A2 (2U)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written Informed Consent (Annex 1)
• Female
• 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
• Subjects aged between 18 and 60 years
• Subjects presenting with moderate to severe wrinkles on the forehead under maximum voluntary contraction of the m. frontalis
• Subjects with positive Minor's test showing sweating on the forehead in standardized conditions described in Annex 2
• 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
• Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using an effective contraceptive method;
• Availability of the patient throughout the duration of the study (112 days)
• Subject agrees not to undergo other cosmetic or dermatological procedures during the study
• Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol

You may not qualify if:

• Pregnant women or women intending to become pregnant in the next 4 months after screening for eligibility
• Subjects who are lactating
• Subjects having undergone botulinum toxin treatment within the last 6 months
• Subjects participating in other clinical trials
• Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharoplasty or brow lift
• Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results
• Subjects presenting fronto-parietal alopecia according to the Norwood-Hamilton classification
• Subjects with neoplastic, muscular or neurological diseases
• Subjects using aminoglycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers
• Subjects with inflammation or active infection in the area to be injected
• Subjects presenting evident facial asymmetry
• 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
• Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron diseases
• Subjects with coagulation disorders or using anticoagulants
• Subjects with known systemic autoimmune diseases

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead

Study Sites (1)

Brazilian Center for Dermatological Studies

Porto Alegre, Rio Grande do Sul, 90570-040, Brazil

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

The field of muscular effects of the studied toxins was objectively measured by EMG and it is not very precise. However, there is no more precise objective measurement to currently evaluate the field effects in muscles than EMG.

Results Point of Contact

• Title: Débora Zechmeister do Prado
• Organization: CBED

cbed@cbed.org.br

55 51 30262633

Study Officials

• Doris Hexsel, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: August 17, 2009
• Study Start: May 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 15, 2009
• Results First Posted: August 17, 2009

Record last verified: 2009-11

Locations

BR (1)