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Trial record 89 of 720 for:    Botulinum Toxins, Type A

Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

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ClinicalTrials.gov Identifier: NCT01014871
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : April 5, 2012
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Wrinkles
Interventions Drug: Botulinum Toxin Type A - Azzalure
Drug: Botulinum Toxin Type A - Vistabel
Enrollment 30
Recruitment Details Recruitment process: patients from private practice - Recruitment period: First Patient In = 13 July 2009 Last Patient In = 09 November 2009 - Type of location: hospital
Pre-assignment Details  
Arm/Group Title Vistabel/Azzalure
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at Baseline:

  • 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead
  • 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Vistabel/Azzalure
Hide Arm/Group Description

at Baseline:

  • 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead
  • 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
46.4  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
30
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 30 participants
30
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5
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Hide Analysis Population Description
Intention To Treat
Arm/Group Title Azzalure Vistabel
Hide Arm/Group Description:

at Baseline:

- 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead

at Baseline:

- 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
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)
Month 4 at rest 1.0  (0.5) 1.0  (0.6)
Month 5 at rest 1.2  (0.6) 1.3  (0.6)
Baseline at maximum contraction 2.1  (0.3) 2.1  (0.3)
Day 1 at maximum contraction 1.8  (0.6) 1.8  (0.6)
Day 2 at maximum contraction 1.6  (0.6) 1.5  (0.6)
Day 3 at maximum contraction 1.2  (0.7) 1.1  (0.6)
Day 7 at maximum contraction 0.7  (0.7) 0.7  (0.7)
Day 10 at maximum contraction 0.6  (0.7) 0.6  (0.6)
Day 14 at maximum contraction 0.5  (0.6) 0.4  (0.5)
Day 30 at maximum contraction 0.5  (0.6) 0.5  (0.5)
Month 4 at maximum contraction 1.5  (0.5) 1.4  (0.6)
Month 5 at maximum contraction 1.8  (0.6) 1.9  (0.5)
Time Frame 5 months
Adverse Event Reporting Description All medical clinical events occurred after subject’s consent signature and during the study, whether observed by the Evaluator/Injector or reported by the Subject and whether or not thought to be treatment-related were considered adverse events and collected.
 
Arm/Group Title Azzalure Vistabel
Hide Arm/Group Description intra-individual comparison intra-individual comparison
All-Cause Mortality
Azzalure Vistabel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Azzalure Vistabel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Azzalure Vistabel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/30 (50.00%)      18/30 (60.00%)    
Eye disorders     
EYELID PTOSIS   2/30 (6.67%)  2 2/30 (6.67%)  2
Gastrointestinal disorders     
DENTAL DISCOMFORT   2/30 (6.67%)  2 2/30 (6.67%)  2
General disorders     
INJECTION SITE PARAESTHESIA   1/30 (3.33%)  1 2/30 (6.67%)  2
Infections and infestations     
NASOPHARYNGITIS   3/30 (10.00%)  3 3/30 (10.00%)  3
Musculoskeletal and connective tissue disorders     
SENSATION OF HEAVINESS   2/30 (6.67%)  2 2/30 (6.67%)  2
Nervous system disorders     
FACIAL PARESIS   4/30 (13.33%)  4 4/30 (13.33%)  4
HEADACHE   4/30 (13.33%)  4 5/30 (16.67%)  5
MIGRAINE   2/30 (6.67%)  3 2/30 (6.67%)  3
Respiratory, thoracic and mediastinal disorders     
PHARYNGOLARYNGEAL PAIN   2/30 (6.67%)  2 2/30 (6.67%)  2
Skin and subcutaneous tissue disorders     
EYELID OEDEMA   5/30 (16.67%)  5 5/30 (16.67%)  5
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Disclosure agreement in full force and effect for a period of 10 years.
Results Point of Contact
Name/Title: Florence Paliargues / CPM
Organization: Galderma
Phone: +33492952957
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01014871     History of Changes
Other Study ID Numbers: RD.03.SPR.29081
First Submitted: November 16, 2009
First Posted: November 17, 2009
Results First Submitted: August 12, 2011
Results First Posted: April 5, 2012
Last Update Posted: April 20, 2012