NCT01014871

Brief 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. Allocation of each BoNT-A to each side of the forehead will be randomized.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 5, 2012

Completed
Last Updated

February 18, 2021

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

November 16, 2009

Results QC Date

August 12, 2011

Last Update Submit

February 16, 2021

Conditions

Wrinkles

Keywords

Forehead Wrinkles Toxin

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5

Study Arms (1)

intra-individual comparison

OTHER
Drug: Botulinum Toxin Type A - AzzalureDrug: Botulinum Toxin Type A - Vistabel

Interventions

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.

intra-individual comparison
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.

intra-individual comparison

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Charité Hospital

Berlin, Germany

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Florence Paliargues / CPM
Organization
Galderma
florence.paliargues@galderma.com
+33492952957

Study Officials

  • Pr Rzany, MD

    La Charité Hospital, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 17, 2009

Study Start

July 1, 2009

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

February 18, 2021

Results First Posted

April 5, 2012

Record last verified: 2012-04

Locations

DE(1)