Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A

Tracking Information
First Submitted Date ICMJE	October 5, 2009
First Posted Date ICMJE	October 6, 2009
Results First Submitted Date	October 28, 2009
Results First Posted Date	April 27, 2010
Last Update Posted Date	June 2, 2010
Study Start Date ICMJE	May 2005
Actual Primary Completion Date	November 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 13, 2010)	Horizontal Action Halo Diameter at 28 Days [ Time Frame: 28 Days ]The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).; Horizontal Action Halo Diameter at 112 Days [ Time Frame: 112 days ]The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).
Original Primary Outcome Measures ICMJE; (submitted: October 5, 2009)	Horizontal Action Halo Diameter at 28 Days [ Time Frame: 28 Days ]; Horizontal Action Halo Diameter at 112 Days [ Time Frame: 112 days ]
Change History	Complete list of historical versions of study NCT00989768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 13, 2010)	ECMAP in m. Frontialis [ Time Frame: 28 days ]The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).; ECMAP in m. Frontialis [ Time Frame: 112 days ]The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).
Original Secondary Outcome Measures ICMJE; (submitted: October 5, 2009)	ECMAP in m. Frontialis BoNT A1(5U) X BoNT A2 (2U) [ Time Frame: 28 days ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A
Official Title ICMJE	Field Effects of Two Commercial Preparations of Botulinum Toxin Type a Administered to the Frontalis Muscles
Brief Summary	The objective of this study is to compare the field of effects 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.
Detailed Description	This was a monocentric, prospective, randomized and double-blind study. Twenty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. Subjects have received botulinum toxin type-A injections in two forehead sites, Botox 2U and Dysport 5U, both reconstituted in the same volume of 0.02 mL per point. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Wrinkles in Frontal Area
Intervention ICMJE	Drug: Botulinum Toxin Type A (Dysport®) Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 5 units will be injected in the left or right forehead side.; Drug: Botulinum Toxin Type A/Botox® 2 units will be injected in the left or right forehead side.(opposite side of dysport injection); Drug: Botulinum Toxin Type A/Dysport® Botulinum toxin A (Dysport®)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, 2:1 ratio Dysport/Botox.
Study Arms	Experimental: Botulinum toxin type - A; Dysport® compared to Botox®; Interventions: Drug: Botulinum Toxin Type A (Dysport®); Drug: Botulinum Toxin Type A/Botox®; Drug: Botulinum Toxin Type A/Dysport®
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 5, 2009)	29
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2007
Actual Primary Completion Date	November 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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 *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).; 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 Exclusion Criteria: 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; Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol; Any condition that, in the opinion of the investigator, can compromise the evaluation of the study
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Brazil
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00989768
Other Study ID Numbers ICMJE	01-CBED06b
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Doris Hexsel, CBED
Study Sponsor ICMJE	Brazilan Center for Studies in Dermatology
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Doris M Hexsel, MD
PRS Account	Brazilan Center for Studies in Dermatology
Verification Date	October 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP