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The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment of primary axillary hyperhidrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
|
| ANT-1207 Dose 1 | Experimental | Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
|
| ANT-1207 Dose 2 | Experimental | Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
|
| ANT-1207 Dose 3 | Experimental | Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
|
| ANT-1207 Dose 4 | Experimental | Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle | Biological | Vehicle for ANT-1207 liniment formulation without active ingredient. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50% | The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities. GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities. The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in HDSS score by ≥ 2 points is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan-En Lin | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Marcus Research Clinic, Inc. | Hialeah | Florida | 33015 | United States | ||
| Baumann Cosmetic & Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| FG001 | ANT-1207 Dose 1 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ANT-1207 Dose 5 | Experimental | Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
|
| ANT-1207 |
| Biological |
Botulinum toxin Type A topical liniment (ANT-1207). |
|
| Baseline, Weeks 4, 8, 12 and 18 |
| Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in GSP by ≥ 50% is reported. | Baseline, Weeks 4, 8, 12 and 18 |
| Miami |
| Florida |
| 33137 |
| United States |
| Radiant Research, Inc. | Pinellas Park | Florida | 33781 | United States |
| Research Institute of the Southeast, LLC | West Palm Beach | Florida | 33401 | United States |
| Shideler Clinical Research Center | Carmel | Indiana | 46032 | United States |
| William Coleman III, MD, APMC | Metairie | Louisiana | 70006 | United States |
| Lupo Center for Aesthetic & General Dermatology | New Orleans | Louisiana | 70124 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| JUVA Skin and Laser Center | New York | New York | 10021 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| PMG Research of Cary | Cary | North Carolina | 27518 | United States |
| Allus Clinical Research | Jenkintown | Pennsylvania | 19046 | United States |
| Dermatology and Laser Center of Charleston, PA | Charleston | South Carolina | 29414 | United States |
| The Skin Wellness Center | Knoxville | Tennessee | 37922 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Westlake Dermatology Clinical Research Center | Austin | Texas | 78746 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Virginia Clinical Research Inc. | Norfolk | Virginia | 23507 | United States |
| FG002 | ANT-1207 Dose 2 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| FG003 | ANT-1207 Dose 3 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| FG004 | ANT-1207 Dose 4 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| FG005 | ANT-1207 Dose 5 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| BG001 | ANT-1207 Dose 1 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| BG002 | ANT-1207 Dose 2 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| BG003 | ANT-1207 Dose 3 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| BG004 | ANT-1207 Dose 4 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| BG005 | ANT-1207 Dose 5 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50% | The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities. GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported. | Modified Intent-to-Treat (mITT) population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the last observation carried forward (LOCF) approach. | Posted | Number | percentage of participants | Baseline, Week 12 |
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| Secondary | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities. The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in HDSS score by ≥ 2 points is reported. | mITT population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the LOCF approach. | Posted | Number | percentage of participants | Baseline, Weeks 4, 8, 12 and 18 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in GSP by ≥ 50% is reported. | mITT population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the LOCF approach. | Posted | Number | percentage of participants | Baseline, Weeks 4, 8, 12 and 18 |
|
126 Days
Safety population included all randomized patients who received at least 1 dose of double-blind investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle | Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. | 1 | 27 | 0 | 27 | ||
| EG001 | ANT-1207 Dose 1 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. | 0 | 22 | 0 | 22 | ||
| EG002 | ANT-1207 Dose 2 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. | 0 | 28 | 2 | 28 | ||
| EG003 | ANT-1207 Dose 3 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. | 0 | 21 | 0 | 21 | ||
| EG004 | ANT-1207 Dose 4 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. | 0 | 22 | 0 | 22 | ||
| EG005 | ANT-1207 Dose 5 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. | 0 | 25 | 1 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrectomy | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 1-877-277-8566 | IR-CTRegistration@allergan.com |
| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 36 to 50 years |
|
| >50 years |
|
| Male |
|
Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| OG003 | ANT-1207 Dose 3 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| OG004 | ANT-1207 Dose 4 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| OG005 | ANT-1207 Dose 5 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
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|
| OG003 | ANT-1207 Dose 3 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| OG004 | ANT-1207 Dose 4 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| OG005 | ANT-1207 Dose 5 | Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
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