Hyperhidrosis
Conditions
Brief summary
The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment of primary axillary hyperhidrosis.
Interventions
BIOLOGICALVehicle
Vehicle for ANT-1207 liniment formulation without active ingredient.
BIOLOGICALANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ages 18 - 70 years of age * diagnosis of primary axillary hyperhidrosis * HDSS score of ≥3 * threshold sweat production/axilla in 5 minutes as measured gravimetrically * willingness to shave underarms prior to each study visit
Exclusion criteria
* botulinum toxin treatment in the prior 6 months * signs of infection in the axilla * skin affliction in the axilla requiring medical treatment * oral anticholinergic treatment * use of antiperspirants, deodorants, powders, or lotions * use of axillary depilatories or axillary epilation * history of surgery or other interventions for axillary hyperhidrosis * female subjects who are pregnant or are nursing a child
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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% | Baseline, Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Baseline, Weeks 4, 8, 12 and 18 | 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. |
| Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Baseline, Weeks 4, 8, 12 and 18 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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. | 22 |
| 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. | 28 |
| 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. | 21 |
| 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. | 22 |
| 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. | 25 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 | 4 | 2 | 3 | 5 |
| Overall Study | Other Miscellaneous Reasons | 1 | 0 | 1 | 1 | 1 | 0 |
| Overall Study | Treatment Failure/Lack of Efficacy | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrew Consent | 5 | 6 | 1 | 4 | 1 | 1 |
Baseline characteristics
| Characteristic | Vehicle | ANT-1207 Dose 1 | ANT-1207 Dose 2 | ANT-1207 Dose 3 | ANT-1207 Dose 4 | ANT-1207 Dose 5 | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 32.15 years STANDARD_DEVIATION 11.83 | 30.18 years STANDARD_DEVIATION 6.7 | 32.50 years STANDARD_DEVIATION 9.86 | 30.48 years STANDARD_DEVIATION 6.9 | 32.36 years STANDARD_DEVIATION 9.56 | 32.64 years STANDARD_DEVIATION 10.55 | 31.79 years STANDARD_DEVIATION 9.46 |
| Age, Customized 18 to 35 years | 19 participants | 18 participants | 19 participants | 16 participants | 13 participants | 17 participants | 102 participants |
| Age, Customized 36 to 50 years | 5 participants | 4 participants | 8 participants | 5 participants | 8 participants | 7 participants | 37 participants |
| Age, Customized >50 years | 3 participants | 0 participants | 1 participants | 0 participants | 1 participants | 1 participants | 6 participants |
| Sex: Female, Male Female | 16 Participants | 12 Participants | 17 Participants | 14 Participants | 11 Participants | 12 Participants | 82 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 11 Participants | 07 Participants | 11 Participants | 13 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 22 | 2 / 28 | 0 / 21 | 0 / 22 | 1 / 25 |
| serious Total, serious adverse events | 1 / 27 | 0 / 22 | 0 / 28 | 0 / 21 | 0 / 22 | 0 / 25 |
Outcome results
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle | 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% | 3.70 percentage of participants |
| ANT-1207 Dose 1 | 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% | 13.64 percentage of participants |
| ANT-1207 Dose 2 | 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% | 17.86 percentage of participants |
| ANT-1207 Dose 3 | 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% | 14.29 percentage of participants |
| ANT-1207 Dose 4 | 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% | 14.29 percentage of participants |
| ANT-1207 Dose 5 | 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% | 12.00 percentage of participants |
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.
Time frame: Baseline, Weeks 4, 8, 12 and 18
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 18 | 51.85 percentage of participants |
| Vehicle | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 12 | 66.67 percentage of participants |
| Vehicle | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 4 | 62.96 percentage of participants |
| Vehicle | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 8 | 55.56 percentage of participants |
| ANT-1207 Dose 1 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 12 | 63.64 percentage of participants |
| ANT-1207 Dose 1 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 4 | 72.73 percentage of participants |
| ANT-1207 Dose 1 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 18 | 54.55 percentage of participants |
| ANT-1207 Dose 1 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 8 | 72.73 percentage of participants |
| ANT-1207 Dose 2 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 18 | 64.29 percentage of participants |
| ANT-1207 Dose 2 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 4 | 71.43 percentage of participants |
| ANT-1207 Dose 2 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 8 | 71.43 percentage of participants |
| ANT-1207 Dose 2 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 12 | 67.86 percentage of participants |
| ANT-1207 Dose 3 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 8 | 57.14 percentage of participants |
| ANT-1207 Dose 3 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 4 | 71.43 percentage of participants |
| ANT-1207 Dose 3 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 18 | 47.62 percentage of participants |
| ANT-1207 Dose 3 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 12 | 47.62 percentage of participants |
| ANT-1207 Dose 4 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 8 | 52.38 percentage of participants |
| ANT-1207 Dose 4 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 4 | 61.90 percentage of participants |
| ANT-1207 Dose 4 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 12 | 71.43 percentage of participants |
| ANT-1207 Dose 4 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 18 | 61.90 percentage of participants |
| ANT-1207 Dose 5 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 18 | 76.00 percentage of participants |
| ANT-1207 Dose 5 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 4 | 72.00 percentage of participants |
| ANT-1207 Dose 5 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 8 | 72.00 percentage of participants |
| ANT-1207 Dose 5 | Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | Week 12 | 72.00 percentage of participants |
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.
Time frame: Baseline, Weeks 4, 8, 12 and 18
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 4 | 29.63 percentage of participants |
| Vehicle | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 8 | 11.11 percentage of participants |
| Vehicle | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 12 | 7.41 percentage of participants |
| Vehicle | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 18 | 7.41 percentage of participants |
| ANT-1207 Dose 1 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 12 | 27.27 percentage of participants |
| ANT-1207 Dose 1 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 8 | 22.73 percentage of participants |
| ANT-1207 Dose 1 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 4 | 13.64 percentage of participants |
| ANT-1207 Dose 1 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 18 | 22.73 percentage of participants |
| ANT-1207 Dose 2 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 18 | 21.43 percentage of participants |
| ANT-1207 Dose 2 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 12 | 25.00 percentage of participants |
| ANT-1207 Dose 2 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 8 | 28.57 percentage of participants |
| ANT-1207 Dose 2 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 4 | 21.43 percentage of participants |
| ANT-1207 Dose 3 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 4 | 9.52 percentage of participants |
| ANT-1207 Dose 3 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 18 | 19.05 percentage of participants |
| ANT-1207 Dose 3 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 8 | 19.05 percentage of participants |
| ANT-1207 Dose 3 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 12 | 19.05 percentage of participants |
| ANT-1207 Dose 4 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 12 | 14.29 percentage of participants |
| ANT-1207 Dose 4 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 18 | 23.81 percentage of participants |
| ANT-1207 Dose 4 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 8 | 14.29 percentage of participants |
| ANT-1207 Dose 4 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 4 | 28.57 percentage of participants |
| ANT-1207 Dose 5 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 8 | 4.00 percentage of participants |
| ANT-1207 Dose 5 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 12 | 12.00 percentage of participants |
| ANT-1207 Dose 5 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 18 | 8.00 percentage of participants |
| ANT-1207 Dose 5 | Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | Week 4 | 16.00 percentage of participants |