Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001421-17 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Despite the wealth of information in the literature regarding the cosmetic applications of botulinum type A toxin (BoNT-A), and the widespread use of the BoNT-A for cosmetic applications, the number of randomised, controlled clinical trials is small. Much of the published information is based on open-label studies or anecdotal data. Of the robust trial data that is available, the vast majority relates to the treatment of glabellar lines, and there is little data available regarding the use of BoNT-A in lateral canthal lines. This study aims to determine the optimum dose for the use of BoNT-A in this area.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in severity of crow's feet at maximum smile at week 4, compared to baseline, assessed photographically by independent panel |
| Measure | Description | Time Frame |
|---|---|---|
| At week 2,4,8,12,16,20,24, compared to baseline: change in severity of crow's feet at rest & max. smile, assessed by investigator & independent panel (photographically); change in patient satisfaction with appearance of crow's feet & general appearance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UK Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Bel Air | Bordeaux | 33200 | France | |||
| Centre Hospitalier Universitaire de Nice |
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nice |
| 06002 |
| France |
| Service de Chirurgie Maxillo Faciale | Saint-Cloud | 92211 | France |
| Charite-Universitatsmedizin Berlin | Berlin | 10117 | Germany |
| Dermatologie, Stadt. Klinikum Dresden-Friedrichstadt | Dresden | 01067 | Germany |
| Universitats - Hautklinik | Homburg | 66421 | Germany |
| The Cambridge Private Hospital | Cambridge | England | SG8 5QD | United Kingdom |
| Harley Street | London | England | W1G 7LE | United Kingdom |
| The Golden Jubilee National Hospital | Clydebank | Scotland | G81 4HX | United Kingdom |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |