Trial Outcomes & Findings for Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis (NCT NCT02479139)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

145 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2017-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.	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.
Overall Study STARTED	27	22	28	21	22	25
Overall Study COMPLETED	19	12	21	14	17	19
Overall Study NOT COMPLETED	8	10	7	7	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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.	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.
Overall Study Lost to Follow-up	2	4	4	2	3	5
Overall Study Withdrew Consent	5	6	1	4	1	1
Overall Study Treatment Failure/Lack of Efficacy	0	0	1	0	0	0
Overall Study Other Miscellaneous Reasons	1	0	1	1	1	0

Baseline Characteristics

Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle n=27 Participants 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 n=22 Participants 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 n=28 Participants 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 n=21 Participants 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 n=22 Participants 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.	ANT-1207 Dose 5 n=25 Participants 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.	Total n=145 Participants Total of all reporting groups
Age, Continuous	32.15 years STANDARD_DEVIATION 11.83 • n=5 Participants	30.18 years STANDARD_DEVIATION 6.70 • n=7 Participants	32.50 years STANDARD_DEVIATION 9.86 • n=5 Participants	30.48 years STANDARD_DEVIATION 6.90 • n=4 Participants	32.36 years STANDARD_DEVIATION 9.56 • n=21 Participants	32.64 years STANDARD_DEVIATION 10.55 • n=8 Participants	31.79 years STANDARD_DEVIATION 9.46 • n=8 Participants
Age, Customized 18 to 35 years	19 participants n=5 Participants	18 participants n=7 Participants	19 participants n=5 Participants	16 participants n=4 Participants	13 participants n=21 Participants	17 participants n=8 Participants	102 participants n=8 Participants
Age, Customized 36 to 50 years	5 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants	5 participants n=4 Participants	8 participants n=21 Participants	7 participants n=8 Participants	37 participants n=8 Participants
Age, Customized >50 years	3 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	1 participants n=8 Participants	6 participants n=8 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants	14 Participants n=4 Participants	11 Participants n=21 Participants	12 Participants n=8 Participants	82 Participants n=8 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	07 Participants n=4 Participants	11 Participants n=21 Participants	13 Participants n=8 Participants	63 Participants n=8 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Vehicle n=27 Participants 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 n=22 Participants 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 n=28 Participants 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 n=21 Participants 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 n=21 Participants 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.	ANT-1207 Dose 5 n=25 Participants 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.
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	13.64 percentage of participants	17.86 percentage of participants	14.29 percentage of participants	14.29 percentage of participants	12.00 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Vehicle n=27 Participants 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 n=22 Participants 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 n=28 Participants 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 n=21 Participants 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 n=21 Participants 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.	ANT-1207 Dose 5 n=25 Participants 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.
Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points Week 4	29.63 percentage of participants	13.64 percentage of participants	21.43 percentage of participants	9.52 percentage of participants	28.57 percentage of participants	16.00 percentage of participants
Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points Week 8	11.11 percentage of participants	22.73 percentage of participants	28.57 percentage of participants	19.05 percentage of participants	14.29 percentage of participants	4.00 percentage of participants
Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points Week 12	7.41 percentage of participants	27.27 percentage of participants	25.00 percentage of participants	19.05 percentage of participants	14.29 percentage of participants	12.00 percentage of participants
Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points Week 18	7.41 percentage of participants	22.73 percentage of participants	21.43 percentage of participants	19.05 percentage of participants	23.81 percentage of participants	8.00 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Vehicle n=27 Participants 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 n=22 Participants 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 n=28 Participants 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 n=21 Participants 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 n=21 Participants 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.	ANT-1207 Dose 5 n=25 Participants 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.
Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% Week 18	51.85 percentage of participants	54.55 percentage of participants	64.29 percentage of participants	47.62 percentage of participants	61.90 percentage of participants	76.00 percentage of participants
Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% Week 4	62.96 percentage of participants	72.73 percentage of participants	71.43 percentage of participants	71.43 percentage of participants	61.90 percentage of participants	72.00 percentage of participants
Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% Week 8	55.56 percentage of participants	72.73 percentage of participants	71.43 percentage of participants	57.14 percentage of participants	52.38 percentage of participants	72.00 percentage of participants
Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% Week 12	66.67 percentage of participants	63.64 percentage of participants	67.86 percentage of participants	47.62 percentage of participants	71.43 percentage of participants	72.00 percentage of participants

Adverse Events

Vehicle

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths