Glabellar FurrowsPhase 4NCT00856999

Botox Cosmetic and the Young Patient With Glabellar Furrows

A Phase 4 study testing Botox in people with Glabellar Furrows, run by Oregon Health and Science University.

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

Who is it for?: Ages 30 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Glabellar Furrows
What is being tested?: Botox
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: 8 Feb 2005to 17 Nov 2010
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 30 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female
Fitzpatrick Skin Types I-III
Between 30 and 50 years of age
At least moderate severity at maximum frown

Who cannot join

Prior botulinum toxin treatment
Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as aminoglycoside antibiotics) that might interfere with neuromuscular function
Any other condition or situation that might put the subject at significant risk, confound the study results (such as significant pre-existing brow or eyelid ptosis)
Allergy or sensitivity to any study component
Participation in another clinical study within 30 days of the study start date
Are planning other facial cosmetic procedures during the study period, or are pregnant, breastfeeding, or planning a pregnancy during the study.

About this study

The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox injections will be used to see if the effects of the Botox treatment last longer than the effects of the standard injection regimen.

Conditions: Glabellar Furrows
Being tested: Botox
Keywords: Glabellar lines of moderate severity at maximum frown

What participants receive

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

BotoxDrug
Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups

Study groups in NCT00856999
Study group	Role	What they receive
Botox	Experimental	Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups Receives: Drug: Botox

What is being measured

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

Reduction of the Facial Wrinkle Scale
Four-point validated facial wrinkle scale (FWS) Minimum score = 0 (no wrinkles) Maximum score = 3 (deep wrinkles)
Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase
Measured: 26 months
Patient Assessed Frown-line Improvement
Four-point satisfaction scale Neutral = 0 (minimum score) Somewhat satisfied = 1 Definitely satisfied = 2 Greatly satisfied = 3 Couldn't be more satisfied = 4 (maximum score)
Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase
Measured: 20 months

Timeline

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

8 Feb 200517 Nov 2010

First posted6 Mar 2009 (estimated)
Study start8 Feb 2005
Primary completion17 Nov 2010
Study completion17 Nov 2010

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.
Other trials for Glabellar FurrowsStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00856999
Sponsor's protocol ID: AGNR-08-0093
Status last verified: Jul 2019
First submitted: 4 Mar 2009
Last updated: 23 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Botox Cosmetic and the Young Patient With Glabellar Furrows
ClinicalTrials.gov ID: NCT00856999
Acronym / sponsor ID: AGNR-08-0093
Conditions: Glabellar Furrows
Keywords: Glabellar lines of moderate severity at maximum frown
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: Allergan
Study start: 8 Feb 2005 (actual)
Primary completion: 17 Nov 2010 (actual)
Study completion: 17 Nov 2010 (actual)
First posted: 6 Mar 2009 (estimated)
Results: Posted 23 Jul 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Botox	Experimental	Drug: BotoxBotox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups

Who may qualify

Ages: 30 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Female
Fitzpatrick Skin Types I-III
Between 30 and 50 years of age
At least moderate severity at maximum frown

Key exclusion criteria (6 listed)

Prior botulinum toxin treatment
Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as aminoglycoside antibiotics) that might interfere with neuromuscular function
Any other condition or situation that might put the subject at significant risk, confound the study results (such as significant pre-existing brow or eyelid ptosis)
Allergy or sensitivity to any study component
Participation in another clinical study within 30 days of the study start date

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
BotoxBotox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups	Drug	Botox

Primary outcome

Reduction of the Facial Wrinkle Scale
Time frame: 26 months
Four-point validated facial wrinkle scale (FWS) Minimum score = 0 (no wrinkles) Maximum score = 3 (deep wrinkles) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase
Patient Assessed Frown-line Improvement
Time frame: 20 months
Four-point satisfaction scale Neutral = 0 (minimum score) Somewhat satisfied = 1 Definitely satisfied = 2 Greatly satisfied = 3 Couldn't be more satisfied = 4 (maximum score) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase

Results and safety

Results posted to the registry on 23 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Botox	50	45

Primary outcome: Reduction of the Facial Wrinkle Scale

Time frame: 26 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Treatment n = 50
Physician Rating	1.86 (0.65)
Subject Rating	2.10 (0.67)

Treatment: p <.001, Wilcoxon (Mann-Whitney)

Primary outcome: Patient Assessed Frown-line Improvement

Time frame: 20 months. Number. Unit: percentage of patients

Measure	Treatment n = 50
Score 0	7
Score 1 to 2.5	24
Score 3 to 4	69

Treatment: p <.0004, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: 26 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Botox	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Roger Dailey, MD principal investigator

Oregon Health and Science University

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Botox in people with Glabellar Furrows, run by Oregon Health and Science University.

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 4 inclusion and 6 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

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 23 Jul 2019). 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?

Reduction of the Facial Wrinkle Scale (time frame: 26 months). The study lists 2 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 NCT00856999.

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 23 Jul 2019.