Facial RhytidesNCT01608659

An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A

An observational study of Facial Rhytides, run by Allergan at 1 site in Argentina.

Completed

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

Trial summary

This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Facial Rhytides
What is being tested?: botulinum toxin Type A
How many people: 110 participants
Where: 1 siteArgentina
Study dates: 1 Apr 2011to 17 Jun 2011
Phase: Observational
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Subjects treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A

Who may be able to join

Previously treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A preparation
Received 2 treatment cycles wtih botulinum toxin Type A (BOTOX®) prior to at least 1 treatment with botulinum toxin Type A (Xeomin®)

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Study site
Buenos Aires

Other trials in Argentina

About this study

This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.

Conditions: Facial Rhytides
Being tested: botulinum toxin Type A

What participants receive

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

botulinum toxin Type ADrug
Also called BOTOX®, Xeomin®
Previous treatment with botulinum toxin Type A for treatment of facial lines

Study groups in NCT01608659
Study group	Role	What they receive
botulinum toxin Type A		Previous treatment with botulinum toxin Type A for treatment of facial lines Receives: Drug: botulinum toxin Type A

What is being measured

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

Average Total Dose Per Treatment Period
Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.
Measured: 24 Months

Secondary outcomes (2)

Inter-Injection Interval Duration of Each Treatment Period
Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.
Measured: 24 Months
Percent of Subjects Reporting Satisfaction With Treatment Effects
Percent of subjects reporting satisfaction with treatment effects per chart notes.
Measured: 24 Months

Timeline

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

1 Apr 201117 Jun 2011

First posted31 May 2012 (estimated)
Study start1 Apr 2011
Primary completion17 Jun 2011
Study completion17 Jun 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 Facial RhytidesStudies 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: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01608659
Sponsor's protocol ID: GMA-BTXC-10-001
Status last verified: Apr 2019
First submitted: 29 May 2012
Last updated: 17 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Banegas RA, Farache F, Rancati A, Chain M, Gallagher CJ, Chapman MA, Caulkins CA. The South American Glabellar Experience Study (SAGE): a multicenter retrospective analysis of real-world treatment patterns following the introduction of incobotulinumtoxinA in Argentina. Aesthet Surg J. 2013 Sep 1;33(7):1039-45. doi: 10.1177/1090820X13503475. Epub 2013 Aug 29.
PubMed 23990584

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?

See locations

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All Facial Rhytides trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A
ClinicalTrials.gov ID: NCT01608659
Acronym / sponsor ID: GMA-BTXC-10-001
Conditions: Facial Rhytides
Study type: Observational
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 1 Apr 2011 (actual)
Primary completion: 17 Jun 2011 (actual)
Study completion: 17 Jun 2011 (actual)
First posted: 31 May 2012 (estimated)
Results: Posted 1 Aug 2012

Clinical summary

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

This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
botulinum toxin Type A	–	Drug: botulinum toxin Type APrevious treatment with botulinum toxin Type A for treatment of facial lines

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A

Key inclusion criteria (2 listed)

Previously treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A preparation
Received 2 treatment cycles wtih botulinum toxin Type A (BOTOX®) prior to at least 1 treatment with botulinum toxin Type A (Xeomin®)

Key exclusion criteria (1 listed)

None

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
botulinum toxin Type AAlso: BOTOX®, Xeomin®Previous treatment with botulinum toxin Type A for treatment of facial lines	Drug	botulinum toxin Type A

Primary outcome

Average Total Dose Per Treatment Period
Time frame: 24 Months
Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.

2 secondary outcomes

Inter-Injection Interval Duration of Each Treatment Period
Time frame: 24 Months
Percent of Subjects Reporting Satisfaction With Treatment Effects
Time frame: 24 Months

Results and safety

Results posted to the registry on 1 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Botulinum Toxin Type A	110	94

Primary outcome: Average Total Dose Per Treatment Period

Time frame: 24 Months. Mean (Standard Deviation). Unit: Units

Measure	Botulinum Toxin Type A n = 34
Treatment Period 1 (BOTOX®) N=34	49.2 (12.77)
Treatment Period 2 (Xeomin®) N=34	48.1 (15.18)
Treatment Period 3 (BOTOX®) N=16	45.8 (4.68)

Population analysed: All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Botulinum Toxin Type A	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23990584Banegas RA, Farache F, Rancati A, Chain M, Gallagher CJ, Chapman MA, Caulkins CA. The South American Glabellar Experience Study (SAGE): a multicenter retrospective analysis of real-world treatment patterns following the introduction of incobotulinumtoxinA in Argentina. Aesthet Surg J. 2013 Sep 1;33(7):1039-45. doi: 10.1177/1090820X13503475. Epub 2013 Aug 29.

Related trials for Facial Rhytides

Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment
Skin Laxity, Wrinkle
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Not yet recruiting
Evaluation of MD60002 Device for Facial Skin Aging
Facial Wrinkles, Skin Aging

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.

Medical Director study director

Allergan

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

Questions about this trial

What is this clinical trial studying?

An observational study of Facial Rhytides, run by Allergan at 1 site in Argentina.

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 2 inclusion and 1 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 Apr 2019. 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 Argentina. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2012). 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?

Average Total Dose Per Treatment Period (time frame: 24 Months). 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 NCT01608659, 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 Apr 2019.