WrinklesPhase 2NCT01014871

Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

A Phase 2 study testing Botulinum Toxin Type A - Azzalure and Botulinum Toxin Type A - Vistabel in people with Wrinkles, run by Galderma R&D at 1 site in Germany.

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

Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison study in subjects with moderate to severe forehead wrinkles. One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at baseline. Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Wrinkles
What is being tested?: Botulinum Toxin Type A - Azzalure and Botulinum Toxin Type A - Vistabel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteGermany
Study dates: Jul 2009to May 2010
Phase: Phase 2
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 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female Subjects of any race, from 18 to 65 years old
Moderate to severe horizontal forehead wrinkles at maximum contraction (2-3 on the Forehead Wrinkles Severity Scale) on both sides of the forehead
Negative urine pregnancy test at the Baseline visit for Subjects of childbearing potential

Who cannot join

Subjects with a washout period for procedure(s)/treatment(s) on the forehead less than:
Retinoid, microdermabrasion, or prescription level glycolic acid treatments 2 weeks
Non-ablative light treatments (e.g. Intense Pulsed Light, light-emitting diodes) 1 month
Ablative skin resurfacing
Non-ablative dermal treatment for skin tightening (e.g. radio-frequency treatments) 6 months
Treatment with a BoNT-A 12 months

Show all 12Show fewer

Soft tissue augmentation (e.g. biodegradable products as collagen or hyaluronic acid preparations) 24 months
Subjects who undergone a surgical facelift;
Permanent or semi-permanent dermal fillers in the forehead area;
Known allergy or hypersensitivity to any botulinum toxin or any component of BoNT-A (1) and/or BoNT-A (2) (see package inserts);
Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics;
Pregnant women, nursing mothers, or women who are planning pregnancy during the study;

Trial locations and contacts

1 site in 1 country.

Germany1 site

La Charité Hospital
Berlin

Other trials in Germany

About this study

Official title: Intra-individual Comparison of the Efficacy of Two Botulinum Toxins Type A on Moderate to Severe Forehead Wrinkles After One Injection

Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison study in subjects with moderate to severe forehead wrinkles.

One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.

Read the detailed description

There are two formulations of BoNT-A available: Botox®/Vistabel®, Allergan and Dysport®/Azzalure®, Ipsen - Galderma. These formulations behave distinctly in different ways electrophysiologically and clinically and results obtained with one formulation cannot be extrapolated to the other. There are only few clinical research directly comparing the two formulations in the treatment of forehead lines.

Conditions: Wrinkles
Being tested: Botulinum Toxin Type A - Azzalure, Botulinum Toxin Type A - Vistabel
Keywords: Forehead Wrinkles Toxin

What participants receive

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

Botulinum Toxin Type A - AzzalureDrug
One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.
Botulinum Toxin Type A - VistabelDrug
One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.

Study groups in NCT01014871
Study group	Role	What they receive
intra-individual comparison	Other	Not described Receives: Drug: Botulinum Toxin Type A - Azzalure; Drug: Botulinum Toxin Type A - Vistabel

What is being measured

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

Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead
Bilateral comparison of forehead wrinkle severity score at rest and at maximum contraction measured by Forehead Wrinkles Severity Scale (0 to 3) at each study visit (Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5)and for each side.
Measured: 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5

Timeline

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

Jul 2009May 2010

First posted17 Nov 2009 (estimated)
Study startJul 2009
Primary completionApr 2010
Study completionMay 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 WrinklesStudies of the same condition, open and under way.
More trials run by Galderma R&DThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01014871
Sponsor's protocol ID: RD.03.SPR.29081
Status last verified: Apr 2012
First submitted: 16 Nov 2009
Last updated: 18 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intra-individual Comparison of the Efficacy of Two Botulinum Toxins Type A on Moderate to Severe Forehead Wrinkles After One Injection
ClinicalTrials.gov ID: NCT01014871
Acronym / sponsor ID: RD.03.SPR.29081
Conditions: Wrinkles
Keywords: Forehead Wrinkles Toxin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Apr 2010 (actual)
Study completion: May 2010 (actual)
First posted: 17 Nov 2009 (estimated)
Results: Posted 5 Apr 2012

Clinical summary

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

Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison study in subjects with moderate to severe forehead wrinkles.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 1

Arm	Type	Receives
intra-individual comparison	Other	Drug: Botulinum Toxin Type A - Azzalure, Drug: Botulinum Toxin Type A - Vistabel

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Female Subjects of any race, from 18 to 65 years old
Moderate to severe horizontal forehead wrinkles at maximum contraction (2-3 on the Forehead Wrinkles Severity Scale) on both sides of the forehead
Negative urine pregnancy test at the Baseline visit for Subjects of childbearing potential

Key exclusion criteria (12 listed)

Subjects with a washout period for procedure(s)/treatment(s) on the forehead less than:
Subjects who undergone a surgical facelift;
Permanent or semi-permanent dermal fillers in the forehead area;
Known allergy or hypersensitivity to any botulinum toxin or any component of BoNT-A (1) and/or BoNT-A (2) (see package inserts);
Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics;

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 A - AzzalureOne botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.	Drug	intra-individual comparison
Botulinum Toxin Type A - VistabelOne botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.	Drug	intra-individual comparison

Primary outcome

Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead
Time frame: 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5
Bilateral comparison of forehead wrinkle severity score at rest and at maximum contraction measured by Forehead Wrinkles Severity Scale (0 to 3) at each study visit (Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5)and for each side.

Results and safety

Results posted to the registry on 5 Apr 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
Vistabel/Azzalure	30	30

Primary outcome: Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead

Time frame: 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Azzalure n = 30	Vistabel n = 30
Baseline at rest	1.4 (0.5)	1.4 (0.5)
Day 1 at rest	1.3 (0.5)	1.3 (0.5)
Day 2 at rest	1.0 (0.6)	1.0 (0.5)
Day 3 at rest	0.9 (0.6)	0.8 (0.5)
Day 7 at rest	0.7 (0.7)	0.7 (0.6)
Day 10 at rest	0.5 (0.6)	0.5 (0.6)
Day 14 at rest	0.6 (0.6)	0.5 (0.6)
Day 30 at rest	0.6 (0.6)	0.6 (0.6)

Population analysed: Intention To Treat

Adverse events

Time frame: 5 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azzalure	0 of 30 (0%)	15 of 30 (50%)	Not reported
Vistabel	0 of 30 (0%)	18 of 30 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Pr Rzany, MD principal investigator

La Charité Hospital, Berlin, Germany

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Botulinum Toxin Type A - Azzalure and Botulinum Toxin Type A - Vistabel in people with Wrinkles, run by Galderma R&D at 1 site in Germany.

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 3 inclusion and 12 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 18 Feb 2021. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 5 Apr 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?

Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead (time frame: 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5). 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 NCT01014871.

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 18 Feb 2021.