Skin WrinklingPhase 4NCT01732809

Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses

A Phase 4 study testing AbobotulinumtoxinA (ABO) and OnabotulinumtoxinA (ONA) in people with Skin Wrinkling, run by Hexsel Dermatology Clinic at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activity. Read more about this study

Who is it for?: Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Skin Wrinkling
What is being tested?: AbobotulinumtoxinA (ABO) and OnabotulinumtoxinA (ONA)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteBrazil
Study dates: Jan 2011to Nov 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Signed consent
Female subjects aged between 18 to 60 years
Phototype I to IV
Moderate to severe wrinkles in the forehead region on maximal contracture of the frontalis muscle according to the Wrinkle Severity Scale
Subjects with the Minor Test* considered positive from grade 3 to 5 on the Minor test sweat intensity scale, showing sweat on the forehead under standardized conditions
Medical history and clinical examination that, in the investigator's opinion, do not prevent the subject from participating in the study or from using the proposed medication

Show all 26Show fewer

Negative urinary pregnancy test at the initial visit for women of childbearing potential
Use of an effective contraceptive method (oral or injectable contraception, abstinence, intrauterine device, diaphragm, hysterectomy or bilateral ovariectomy, tubal attachment, condom, sponge, spermicide or partner with vasectomy) throughout the study for women of childbearing potential
Subjects must agree not to undergo other dermatological or aesthetic treatments during the study period *The Minor test must be the last test to be done. Only the subjects who fulfill all the inclusion criteria above undergo the Minor test to check for sweating in the frontal region. The graduation considered positive for inclusion in the study will be 3 to 5.
Pregnancy or intention to become pregnant during the study period
Breastfeeding
Botulinum toxin treatments in the last 6 months
Subjects participating in other clinical studies
Any surgical procedure performed that has affected the frontal or orbicularis muscle, previous blepharoplasty or eyebrow raising
Any cosmetic procedures, including fillers, or scars that may interfere with the results of the study
Fronto-parietal alopecia according to the Norwood-Hamilton classification
Neoplastic, muscular or neurological diseases
Use of using aminoglycoside antibiotics or penicillamines, quinine or calcium channel blockers or that they will use at any time during the study
Inflammatory or infectious processes at the application site
Evident facial asymmetry
History of adverse event, such as sensitivity to the components of the formula, ptosis or any other adverse event that, in the investigator's opinion, prevents the research subject from participating in the study
Myasthenia Gravis, Eaton-Lambert Syndrome and motor neuron disease
Coagulation disorders or use of anticoagulants
Autoimmune disease
History of poor adherence to treatments or who have shown lack of cooperation to adhere to the study protocol
Any condition that, in the investigator's opinion, could compromise the results of the study

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, 90550-141

Other trials in Brazil

About this study

Official title: Fields of Effects of Two Commercial Preparations of Botulinum Toxin Type A at Equal Labeled Unit Doses

Read the detailed description

This is a prospective, single-center, randomized, double-blind study. All participants were recruited from a research center in Porto Alegre, Brazil, and provided written informed consent. The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activities. Nineteen patients were enrolled and evaluations were performed at baseline and 28 days after treatment.

Conditions: Skin Wrinkling
Being tested: AbobotulinumtoxinA (ABO), OnabotulinumtoxinA (ONA)
Keywords: wrinkles, botulinum toxin, abobotulinumtoxinA, onabotulinumtoxinA, field of anhydrotic effects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AbobotulinumtoxinA (ABO)Drug
Also called Dysport®
Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.
OnabotulinumtoxinA (ONA)Drug
Also called Botox®
Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.

Study groups in NCT01732809
Study group	Role	What they receive
abobotulinumtoxin A	Active comparator	Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received abobotulinumtoxin A in one of the sides of the forehead. Receives: Drug: AbobotulinumtoxinA (ABO)
onabotulinumtoxin A	Active comparator	Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received onabotulinumtoxin A in one of the sides of the forehead. Receives: Drug: OnabotulinumtoxinA (ONA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Horizontal Diameter of the Fields of Anhidrotic Effect
The Horizontal Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.
Measured: 28 days
Vertical Diameter of the Fields of Anhidrotic Effect
The Vertical Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.
Measured: 28 days
Area of the Fields of Anhidrotic Effect
The area of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them.
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.
Measured: 28 days

Secondary outcomes (3)

Wrinkle Severity Scale (WSS) at Maximum Contraction
It is a 4-point validated scale for forehead lines:
0 - None
1. - Mild
2. - Moderate
3. - Severe
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.
Wrinkle scales are used to grade the muscular effects of botulinum toxin.
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.
Measured: Baseline and 28 days
Wrinkle Severity Scale (WSS) at Rest
It its a 4-point validated scale for forehead lines:
0 - None
1. - Mild
2. - Moderate
3. - Severe
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines.
Wrinkle scales are used to grade the muscular effects of botulinum toxin.
The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline.
Measured: Baseline and 28 days
Evoked Compound Muscle Action Potentials (ECMAP)
Amplitude of the evoked compound muscle action potentials in the frontalis muscle on stimulation of the facial nerve performed at baseline and visit 2 using surface electrodes on the forehead and electrical stimulation of the facial nerve according to standard neurophysiologic procedures.
The amplitude of the ECMAP was performed by an experienced neurologist using an electromyography device (Teca Sapphire; Teca Corp).
Measured: Baseline and 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Nov 2011

First posted26 Nov 2012 (estimated)
Study startJan 2011
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Skin WrinklingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01732809
Sponsor's protocol ID: 11-2011
Status last verified: Nov 2020
First submitted: 7 Nov 2012
Last updated: 17 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hexsel D, Hexsel C, Siega C, Schilling-Souza J, Rotta FT, Rodrigues TC. Fields of effects of 2 commercial preparations of botulinum toxin type A at equal labeled unit doses: a double-blind randomized trial. JAMA Dermatol. 2013 Dec;149(12):1386-91. doi: 10.1001/jamadermatol.2013.6440.
PubMed 24108521

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fields of Effects of Two Commercial Preparations of Botulinum Toxin Type A at Equal Labeled Unit Doses
ClinicalTrials.gov ID: NCT01732809
Acronym / sponsor ID: 11-2011
Conditions: Skin Wrinkling
Keywords: wrinkles, botulinum toxin, abobotulinumtoxinA, onabotulinumtoxinA, field of anhydrotic effects
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Hexsel Dermatology ClinicUniversity, hospital or other
Study start: Jan 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 26 Nov 2012 (estimated)
Results: Posted 17 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
abobotulinumtoxin A	Active comparator	Drug: AbobotulinumtoxinA (ABO)Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received abobotulinumtoxin A in one of the sides of the forehead.
onabotulinumtoxin A	Active comparator	Drug: OnabotulinumtoxinA (ONA)Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received onabotulinumtoxin A in one of the sides of the forehead.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (26 listed)

Signed consent
Female subjects aged between 18 to 60 years
Phototype I to IV
Moderate to severe wrinkles in the forehead region on maximal contracture of the frontalis muscle according to the Wrinkle Severity Scale
Subjects with the Minor Test* considered positive from grade 3 to 5 on the Minor test sweat intensity scale, showing sweat on the forehead under standardized conditions

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AbobotulinumtoxinA (ABO)Also: Dysport®Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.	Drug	abobotulinumtoxin A
OnabotulinumtoxinA (ONA)Also: Botox®Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.	Drug	onabotulinumtoxin A

Primary outcome

Horizontal Diameter of the Fields of Anhidrotic Effect
Time frame: 28 days
The Horizontal Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.
Vertical Diameter of the Fields of Anhidrotic Effect
Time frame: 28 days
The Vertical Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.
Area of the Fields of Anhidrotic Effect
Time frame: 28 days
The area of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline.

3 secondary outcomes

Wrinkle Severity Scale (WSS) at Maximum Contraction
Time frame: Baseline and 28 days
Wrinkle Severity Scale (WSS) at Rest
Time frame: Baseline and 28 days
Evoked Compound Muscle Action Potentials (ECMAP)
Time frame: Baseline and 28 days

Results and safety

Results posted to the registry on 17 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	9	9
Group B	10	9

Primary outcome: Horizontal Diameter of the Fields of Anhidrotic Effect

Time frame: 28 days. Mean (Standard Deviation). Unit: centimeters

Measure	Abobotulinumtoxin A n = 18	Onabotulinumtoxin A n = 18
Value	0.84 (0.14)	1.24 (0.24)

Population analysed: Per protocol.

Primary outcome: Vertical Diameter of the Fields of Anhidrotic Effect

Time frame: 28 days. Mean (Standard Deviation). Unit: centimeters

Measure	Abobotulinumtoxin A n = 18	Onabotulinumtoxin A n = 18
Value	1.19 (0.19)	1.50 (0.26)

Population analysed: Per protocol

Primary outcome: Area of the Fields of Anhidrotic Effect

Time frame: 28 days. Mean (Standard Deviation). Unit: centimeters squared

Measure	Abobotulinumtoxin A n = 18	Onabotulinumtoxin A n = 18
Value	0.86 (0.22)	1.49 (0.49)

Population analysed: Per protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abobotulinumtoxin A	0 of 19 (0%)	2 of 19 (10.5%)	Not reported
Onabotulinumtoxin A	0 of 19 (0%)	1 of 19 (5.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24108521Hexsel D, Hexsel C, Siega C, Schilling-Souza J, Rotta FT, Rodrigues TC. Fields of effects of 2 commercial preparations of botulinum toxin type A at equal labeled unit doses: a double-blind randomized trial. JAMA Dermatol. 2013 Dec;149(12):1386-91. doi: 10.1001/jamadermatol.2013.6440.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Doris M Hexsel, MD principal investigator

Brazilian Center for Studies in Dermatology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AbobotulinumtoxinA (ABO) and OnabotulinumtoxinA (ONA) in people with Skin Wrinkling, run by Hexsel Dermatology Clinic at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Horizontal Diameter of the Fields of Anhidrotic Effect (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01732809, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.