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The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label BOTOX | Experimental | Participants will receive BOTOX at Baseline (Day 1) |
|
| Double-Blind Randomized BOTOX | Experimental | Participants will receive BOTOX at Baseline (Day 1) |
|
| Double Blind Randomized Placebo | Placebo Comparator | Participants will receive placebo at Baseline (Day 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox | Drug | Intradermal (ID) injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Unique number of participants who experience one or more treatment emergent adverse event | Baseline (Day 1) to Final Visit (up to Day 97) |
| Number of Participants with Potential Clinically Significant (PCS) changes in vital signs | Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in vital signs from the Baseline visit. | Baseline (Day 1) to Final Visit (up to Day 97) |
| Number of Participants with Potential Clinically Significant (PCS) changes in physical exams | Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in physical exams from the Baseline visit. | Baseline (Day 1) to Final Visit (up to Day 97) |
| Number of Participants with injection site pain/discomfort. | Unique number of participants who experience injection site pain and/or discomfort at the injection site during administration of treatment. | Baseline (Day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin and Cancer Associates, LLP /ID# 225152 | Miami | Florida | 33137-3254 | United States | ||
| Laser & Skin Surgery Center of New York /ID# 225153 |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com.,To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link. | View source |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Placebo |
| Drug |
Intradermal (ID) injection |
|
| New York |
| New York |
| 10016-4974 |
| United States |
| Tennessee Clinical Research Center /ID# 225151 | Nashville | Tennessee | 37215-2885 | United States |
| Austin Institute for Clinical Research /ID# 225154 | Pflugerville | Texas | 78660 | United States |
| Advanced Clinical Research /ID# 225155 | Salt Lake City | Utah | 84101-1345 | United States |
| 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 |