CompletedNCT00959907Updated Dec 15, 2009Results posted

Comparison of Two Commercial Preparations of Botulinum Toxin Type A

A Phase 4 interventional study of BOTULINUM TOXIN TYPE-A in Wrinkles in Frontal Area, sponsored by Brazilan Center for Studies in Dermatology. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-15.

Sponsored by Brazilan Center for Studies in Dermatology · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 29
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: Female

Study 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.

Read the 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.

Conditions studied

Wrinkles in Frontal Area

Keywords

Muscular activity
wrinkles in frontal area
action halos

In context

Lead sponsor

Brazilan Center for Studies in Dermatology is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 29 participants (actual)

Study arms

Active comparator
BoNT A1 (4U)
BoNT A1 (4U): Botulinum toxin A (Dysport®)4 units
Drug: BOTULINUM TOXIN TYPE-A
Active comparator
BoNT-A2 (2U)
BoNT-A2(2U): Botulinum toxin A (Botox®) 2 units
Drug: BOTULINUM TOXIN TYPE-A

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 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).
Time frame: 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.
Time frame: 112 days

Results

Posted Aug 17, 2009

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.

Participant flow

Recruitment process: It is planned to recruit a total of 58 subjects at one single centre, Brazilian Center For Studies in Dermatology, in Porto Alegre, Brazil. The anticipated drop out rate is 10%. Baseline evaluation: May 2005 to July 2007.

Participant flow — Overall Study
Milestone	BoNT A1(4U)	BoNT-A2(2U)
Started	30	29
Completed	27	28
Not completed	3	1
Withdrew: Protocol violation	0	1
Withdrew: Adverse event	1	0
Withdrew: Withdrawal by subject	2	0

Outcome measures

PrimaryHorizontal 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.

Time frame:: 28 days
Reported as:: Mean · centimeter

Horizontal Action Halo Diameter at 28 Days
centimeter	BoNT A1(4U)	BoNT-A2(2U)
Horizontal Action Halo Diameter at 28 Days	1.0526 ± 0.3638	1.0670 ± 0.2239

Statistical analysis

BoNT A1(4U) · t-test, 2 sided · p = 0.832

PrimaryECMAP 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).

Time frame:: 28 days
Reported as:: Mean · microvolts

ECMAP in m. Frontialis BoNT A1(4U) X BoNT A2 (2U)
microvolts	BoNT A1(4U)	BoNT-A2(2U)
ECMAP in m. Frontialis BoNT A1(4U) X BoNT A2 (2U)	276.18 ± 319.15	289.00 ± 303.86

Statistical analysis

BoNT A1(4U) · t-test, 2 sided · p = 0.658
BoNT-A2(2U) · t-test, 2 sided · p = 0.739

PrimaryHorizontal Action Halo Diameter at 112 Days

Time frame:: 112 days
Reported as:: Mean · centimeter

Horizontal Action Halo Diameter at 112 Days
centimeter	BoNT A1(4U)	BoNT-A2(2U)
Horizontal Action Halo Diameter at 112 Days	0.8742 ± 0.3333	1.1196 ± 0.2620

Statistical analysis

BoNT A1(4U) · t-test, 2 sided · p = 0.184

Adverse events

Non-serious events are listed at a 0.15% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BoNT A1(4U)	—	0/26 (0%)	0/26 (0%)
BoNT-A2(2U)	—	0/26 (0%)	0/26 (0%)

Baseline characteristics

Age Continuous
Age Continuous(years)	BoNT A1(4U)	BoNT-A2(2U)	Total
Mean	44.77 ± 8.67	41.86 ± 11.98	42.88 ± 10.54

Sex: Female, Male
Sex: Female, Male(Participants)	BoNT A1(4U)	BoNT-A2(2U)	Total
Female	30	29	59
Male	0	0	0

Study locations

1 site

Brazilian Center for Dermatological Studies
Porto Alegre, Rio Grande do Sul 90570-040, Brazil

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00959907
Lead sponsor: Brazilan Center for Studies in Dermatology
First posted: Aug 17, 2009
Start date: May 2005
Primary completion: Nov 2007
Completion: Dec 2007
Results posted: Aug 17, 2009
Last update: Dec 15, 2009

Study contacts

Doris Hexsel, MD

principal investigator

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Comparison of Two Commercial Preparations of Botulinum Toxin Type A

Study summary

Conditions studied

Keywords

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies from this sponsor

Inclusion criteria

Exclusion criteria