Poster presented at the 36th Fall Clinical Dermatology Conference | Las Vegas, NV | October 12-15, 2017

Patient-Reported Outcomes From Two Randomized, Double-Blind, Vehicle-Controlled Phase 3 Trials 
in Axillary Hyperhidrosis (ATMOS-1 & ATMOS-2)
David M. Pariser,1 Adelaide A. Hebert,2 Janice Drew,3 John Quiring4, Dee Anna Glaser5
1Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA; 2UTHealth McGovern Medical School at Houston, Houston, TX; 3Dermira, Inc., Menlo Park, CA; 4QST Consultations, Allendale, MI; 5Saint Louis University, St. Louis, MO

INTRODUCTION
• Hyperhidrosis affects an estimated 4.8% of the US population, or approximately 

15.3 million people, and negative psychological consequences are experienced by 
approximately 75% of patients with the disorder1

• The prevalence of anxiety and depression is over 3.5 times greater in people with 
hyperhidrosis than in those without it, and there is a positive correlation between 
the severity of hyperhidrosis and rates of anxiety and depression2 

• Topical glycopyrronium tosylate (GT; formerly DRM04) is a cholinergic receptor 
antagonist being developed for the treatment of primary axillary hyperhidrosis in 
patients ≥9 years of age

• GT has been assessed in 2 replicate randomized clinical trials (ATMOS-1 [sites 
in the US and Germany] and ATMOS‑2 [US sites only]); the primary efficacy and 
safety results of these studies have been previously reported3

• Patient‑reported outcomes (PROs) from these pivotal trials were also assessed 
using the 4‑item Axillary Sweating Daily Diary (ASDD),4 6 Weekly Impact Items, and 
the single‑item Patient Global Impression of Change (PGIC) that were developed 
according to current regulatory standards

 – The ASDD/ASDD‑C axillary sweating severity item (Item 2) was specifically 
developed for use as an endpoint in clinical trials in support of approval and 
labeling (also as a useful clinical parameter)

OBJECTIVE
• To evaluate changes in patient‑reported outcomes after 4 weeks of treatment with 

GT compared with vehicle in ATMOS‑1 and ATMOS‑2

METHODS
ATMOS-1 and ATMOS-2 Study Design
• ATMOS‑1 (DRM04‑HH04; NCT02530281) and ATMOS‑2 (DRM04‑HH05; 

NCT02530294) were parallel‑group, 4‑week, double‑blind, phase 3 clinical trials in 
which patients with primary axillary hyperhidrosis were randomized (2:1) to GT or 
vehicle (Figure 1)
 – Coprimary endpoints included ASDD axillary sweating severity item (Item 2) 

responder rate (defined as ≥4‑point improvement from Baseline) at Week 4 
and mean absolute change from Baseline in gravimetrically‑measured sweat 
production at Week 4

• Eligible patients were ≥9 years of age (patients <16 years were only recruited 
at US sites) and had primary axillary hyperhidrosis for ≥6 months, with 
gravimetrically‑measured sweat production of ≥50 mg/5 min in each axilla, ASDD 
Item 2 score ≥4, and Hyperhidrosis Disease Severity Scale (HDSS) grade 3 or 4 

• Patients were excluded for history of a condition that could cause secondary 
hyperhidrosis; prior surgical procedure or treatment with a medical device for 
axillary hyperhidrosis; treatment with iontophoresis within 4 weeks or treatment 
with botulinum toxin for axillary hyperhidrosis within 1 year; axillary use of 
nonprescription antiperspirants within 1 week or prescription antiperspirants within 
2 weeks; new or modified psychotherapeutic medication regimen within 2 weeks; 
treatment with medications having systemic anticholinergic activity, centrally acting 
alpha‑2 adrenergic agonists, or beta‑blockers within 4 weeks unless dose had 
been stable ≥4 months and was not expected to change; and/or conditions that 
could be exacerbated by study medication

Figure 1.  Study Design

Week 0 Week 4

ATMOS-1 and ATMOS-2

Target

Recruitment:

330 patients
randomized 2:1

GT

Vehicle

Patient-Reported Outcomes
• Axillary Hyperhidrosis Patient Measures (AHPM)

 – The ASDD consists of 4 items and was used for patients ≥16 years; patients <16 
years of age completed a modified, 2‑item version of the ASDD, the ASDD‑C 
(Table 1)

 – Patients ≥16 years were additionally asked to complete 6 Weekly Impact items 
and a single-item Patient Global Impression of Change (PGIC) (Table 1)  

• Mean changes from Baseline were summarized by descriptive statistics in the 
intent‑to‑treat (ITT) population (all randomized subjects who were dispensed study 
drug)

 – For ASDD Item 2 (all patients) and ASDD items related to the impact and bother 
of axillary sweating (Items 3 and 4, respectively; patients ≥16 years of age), 
Baseline was defined as the average of ≥4 days of data in the most recent 7 
days prior to randomization

 – For the Weekly Impact items (patients ≥16 years of age), Baseline was defined 
as the last available record prior to Day 1

 – As the PGIC was only administered at the end of study treatment, there was no 
Baseline value

• Missing values for ASDD Items 2 through 4 were not imputed; for Weekly 
Impact Items, the last observation carried forward (LOCF) approach was 
used to impute missing values

• An additional analysis was performed to assess the percent improvement from 
Baseline to Week 4 in ASDD Item 2, 3, and 4 scores

 

Table 1.  Axillary Hyperhidrosis Patient Measures (AHPM)a

Axillary Sweating Daily Diary (ASDD)b 
Instructions: The questions in the diary are designed to measure the severity and 
impact of any underarm sweating you have experienced within the previous 24 hour 
period, including nighttime hours. While you may also experience sweating in other 
locations on your body, please be sure to think only about your underarm sweating 
when answering these questions. 
Please complete the diary each evening before you go to sleep.

Item 1 
[Gatekeeper]

During the past 24 hours, did you have any underarm sweating?
Yes/No  
When Item 1 is answered “no,” Item 2 is skipped and scored as zero

Item 2
During the past 24 hours, how would you rate your underarm sweating at 
its worst?
0 (no sweating at all) to 10 (worst possible sweating) 

Item 3
During the past 24 hours, to what extent did your underarm sweating 
impact your activities?
0 (not at all), 1 (a little bit), 2 (a moderate amount), 3 (a great deal), 
4 (an extreme amount)

Item 4
During the past 24 hours, how bothered were you by your underarm 
sweating? 
0 (not at all bothered), 1 (a little bothered), 2 (moderately bothered), 
3 (very bothered), 4 (extremely bothered)

Axillary Sweating Daily Diary-Children (ASDD-C)c 
Instructions: These questions measure how bad your underarm sweating was last 
night and today. Please think only about your underarm sweating when answering 
these questions. 
Please complete these questions each night before you go to sleep.

Item 1 
[Gatekeeper]

Thinking about last night and today, did you have any underarm sweating? 
Yes/No 
When Item 1 is answered “no,” Item 2 is skipped and scored as zero

Item 2
Thinking about last night and today, how bad was your underarm 
sweating? 
0 (no sweating at all) to 10 (worst possible sweating)

Weekly Impact Itemsb

Instructions: Please respond “Yes” or “No” to each of the following questions.

a.  During the past 7 days, did you ever have to change your shirt during the day 
because of your underarm sweating?

Yes/
No

b.  During the past 7 days, did you ever have to take more than 1 shower or bath 
a day because of your underarm sweating?

Yes/
No

c.  During the past 7 days, did you ever feel less confident in yourself because of 
your underarm sweating?

Yes/
No

d.  During the past 7 days, did you ever feel embarrassed by your underarm 
sweating?

Yes/
No

e.  During the past 7 days, did you ever avoid interactions with other people 
because of your underarm sweating?

Yes/
No

f.  During the past 7 days, did your underarm sweating ever keep you from doing 
an activity you wanted or needed to do?

Yes/
No

Patient Global Impression of Change (PGIC) Itemb 
Overall, how would you rate your underarm sweating now as compared to before 
starting the study treatment?
1 (much better), 2 (moderately better), 3 (a little better), 4 (no difference), 5 (a little worse), 
6 (moderately worse), 7 (much worse)

aASDD/ASDD-C Item 2 is a validated PRO measure
bFor use in patients ≥16 years of age
cFor use in patients ≥9 to < 16 years of age

RESULTS
• A total of 697 patients were randomized and were asked ASDD/ASDD‑C Items 1 

and 2 on a daily basis; 665 patients were ≥16 years of age and were asked ASDD 
items related to the impact and burden of sweating on a daily basis (Items 3 and 4, 
respectively), the Weekly Impact Items on a weekly basis, and the PGIC at end of 
treatment

• Demographic and Baseline disease characteristics from the primary studies are 
presented in Table 2

Table 2.  Demographics and Baseline Disease 
Characteristics

ATMOS-1 ATMOS-2
Vehicle
(N=115)

GT
(N=229)

Vehicle
(N=119)

GT
(N=234)

Demographics
Age (years), mean ± SD 34.0 ± 13.1 32.1 ± 11.2 32.8 ± 11.2 32.6 ± 10.9
Age group, n (%)

<16 years 
≥16 years

    6 (  5.2) 
109 (94.8)

    5 (  2.2)
224 (97.8)

  10 (  8.4) 
109 (91.6)

  11 (  4.7)
223 (95.3)

Male, n (%)   55 (47.8)   99 (43.2)   59 (49.6) 113 (48.3)
White, n (%)   94 (81.7) 182 (79.5) 102 (85.7) 192 (82.1)
BMI (kg/m2), mean ± SD 27.2 ± 4.9 27.6 ± 5.8 28.4 ± 5.5 27.3 ± 5.0

Baseline Disease Characteristics, mean ± SD
Years with primary 
axillary hyperhidrosis 16.0 ± 11.4 13.7 ± 10.4 15.9 ± 9.9 16.9 ± 11.1

Sweat production 
(mg/5 min)a 170.3 ± 164.2 182.9 ± 266.9 181.9 ± 160.1 162.3 ± 149.5

ASDD/ASDD-C Item 2 
(Severity) 7.1 ± 1.7 7.3 ± 1.6 7.2 ± 1.6 7.3 ± 1.6

ASDD Item 3 (Impact)b 2.2 ± 0.9 2.4 ± 0.9 2.3 ± 1.0 2.5 ± 0.8

ASDD Item 4 (Burden)b 2.4 ± 0.9 2.6 ± 0.8 2.5 ± 0.9 2.7 ± 0.9
aGravimetrically-measured 
bMean Baseline scores for ASDD Items 3 and 4 are based on all patients in the ITT populations of ATMOS‑1 and ATMOS‑2 ≥16 
years of age only 
Baseline scores for Items 2 to 4 were based on the average of ≥4 days of data in the most recent 7 days prior to randomization
ASDD, Axillary Sweating Daily Diary; ASDD‑C, ASDD‑Children; BMI, body mass index; GT, topical glycopyrronium tosylate

• The ASDD Item 2 responder rate (coprimary outcome; ≥4‑point improvement) was 
significantly greater for GT‑treated patients than for vehicle‑treated patients in ATMOS‑1 
(53% vs 28%) and ATMOS‑2 (66% vs 27%) (p<0.001 both studies)

• Improvement in axillary sweating severity (ASDD/ASDD‑C Item 2) was greater for GT‑
treated patients compared with vehicle‑treated patients at every study week (Figure 2) 
 – After 4 weeks of treatment in ATMOS‑1, scores improved 58% (‑4.3 point 

change) in GT‑treated patients and 35% (‑2.5) in vehicle‑treated patients 
compared with Baseline

 – After 4 weeks of treatment in ATMOS‑2, scores improved 67% (‑4.9 point 
change) in GT‑treated patients and 36% (‑2.6) in vehicle‑treated patients 
compared with Baseline

Figure 2.  Percent Improvement From Baseline in Axillary 
Sweating Severity (ASDD/ASDD-C Item 2) 
Scores by Week

VehicleGT VehicleGT
80

60

40

20

0

P
e

r
c

e
n

t 
Im

p
r
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v
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m
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 A
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m
 2

)
 S

c
o

r
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s

ATMOS-1

Week

ATMOS-2

0 1 2 3 4

80

60

40

20

0

Week

0 1 2 3 4

67%

36%
35%

58%

Data are representative of the intent‑to‑treat (ITT) population; figures represent the change in scores in terms of percent improvement
ASDD Item 2: During the past 24 hours, how would you rate your underarm sweating at its worst? 0 (no sweating at all) to 10 (worst 
possible sweating)
ASDD‑C Item 2: Thinking about last night and today, how bad was your underarm sweating? 0 (no sweating at all) to 10 (worst 
possible sweating)
ASDD, Axillary Sweating Daily Diary; ASDD‑C, ASDD‑Children; GT, topical glycopyrronium tosylate

• Improvement in scores related to the impact of axillary sweating (ASDD Item 3) 
scores was greater for GT‑treated patients than vehicle‑treated patients at every 
study week (Figure 3) 
 – After 4 weeks of treatment in ATMOS‑1, scores improved by 63% (‑1.5 point 

change) in GT‑treated patients and 39% (‑0.8) in vehicle‑treated patients 
compared with Baseline

 – After 4 weeks of treatment in ATMOS‑2, scores improved by 72% (‑1.7 point 
change) in GT‑treated patients and 41% (‑1.0) in vehicle‑treated patients 
compared with Baseline

Figure 3.  Percent Improvement From Baseline in Scores 
Related to the Impact of Axillary Sweating 
(ASDD Item 3) by Week 

VehicleGT VehicleGT
80

60

40

20

0

P
e

r
c

e
n

t
 I

m
p

r
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v
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m
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a
t
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g
 (

A
S

D
D

 I
t
e

m
 3

)

ATMOS-1

Week

ATMOS-2

0 1 2 3 4

80

60

40

20

0

Week

0 1 2 3 4

72%

41%

63%

39%

Data are representative of the intent‑to‑treat (ITT) population of patients ≥16 years of age; figures represent the change in scores in 
terms of percent improvement
ASDD Item 3: During the past 24 hours, to what extent did your underarm sweating impact your activities? 0 (not at all), 1 (a little 
bit), 2 (a moderate amount), 3 (a great deal), 4 (an extreme amount)
ASDD, Axillary Sweating Daily Diary; GT, topical glycopyrronium tosylate

• Improvement in scores related to the bother of axillary sweating (ASDD Item 4) 
was greater in GT‑treated patients than vehicle‑treated patients at every study 
week (Figure 4) 
 – After 4 weeks of treatment in ATMOS‑1, Item 4 scores improved by 64% (‑1.7 

point change) in GT‑treated patients and by 39% (‑0.9) in vehicle‑treated 
patients compared with Baseline

 – After 4 weeks of treatment in ATMOS‑2, Item 4 scores improved by 72% (‑1.9 
point change) in GT‑treated patients and by 41% (‑1.0) in vehicle‑treated patients 
compared with Baseline 

Figure 4.  Percent Improvement From Baseline in Scores 
Related to the Bother of Axillary Sweating 
(ASDD Item 4) by Week 

VehicleGT VehicleGT
80

60

40

20

0

P
e

r
c

e
n

t 
Im

p
r
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v
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m
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in
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c
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B
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A

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 (

A
S

D
D

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t
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m
 4

)

ATMOS-1

Week

ATMOS-2

0 1 2 3 4

80

60

40

20

0

Week

0 1 2 3 4

72%

41%

64%

39%

Data are representative of the intent‑to‑treat (ITT) population of patients ≥16 years of age; figures represent the change in scores in 
terms of percent improvement
ASDD Item 4: During the past 24 hours, how bothered were you by your underarm sweating? 0 (not at all bothered), 1 (a little 
bothered), 2 (moderately bothered), 3 (very bothered), 4 (extremely bothered)
ASDD, Axillary Sweating Daily Diary; GT, topical glycopyrronium tosylate

• The proportion of patients who were negatively impacted by aspects of sweating 
(Weekly Impact items) decreased at Week 4 for all patients regardless of treatment; 
the magnitude of the decrease was greater in patients treated with GT than with 
vehicle on all items, indicating greater improvement with GT treatment (Figure 5)

Figure 5. Proportion of Patients Answering ‘Yes’ to 
Weekly Impact Items 

85.6%

32.1%

a. Needed to
change shirt

during the day

59.2%

23.7%

b. Needed ≥1
shower/bath

a day

91.0%

38.8%

c. Felt less
confident

98.5%

43.8%

d. Felt
embarrassed

67.7%

17.9%

e. Avoided
interactions

62.7%

13.8%

f. Kept from
doing an
activity

80.6%

50.5%

a. Needed to
change shirt

during the day

62.1%

43.1%

b. Needed ≥1
shower/bath

a day

86.4%

58.7%

c. Felt less
confident

93.2%

63.3%

d. Felt
embarrassed

68.9%

34.9%

e. Avoided
interactions

49.5%

21.1%

f. Kept from
doing an
activity

87.5%

22.5%

a. Needed to
change shirt

during the day

55.0%

14.9%

b. Needed ≥1
shower/bath

a day

93.0%

33.3%

c. Felt less
confident

96.0%

39.2%

d. Felt
embarrassed

67.0%

15.8%

e. Avoided
interactions

59.5%

10.8%

f. Kept from
doing an
activity

87.0%

55.0%

a. Needed to
change shirt

during the day

52.0%

24.8%

b. Needed ≥1
shower/bath

a day

93.0%

61.5%

c. Felt less
confident

97.0%

67.0%

d. Felt
embarrassed

61.0%

34.9%

e. Avoided
interactions

56.0%

31.2%

f. Kept from
doing an
activity

Baseline Week 4 Baseline Week 4

80

100

60

40

20

0

80

100

60

40

20

0

80

100

60

40

20

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80

100

60

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Data are representative of the intent‑to‑treat (ITT) population of patients ≥16 years of age
GT, topical glycopyrronium tosylate

• Following treatment in ATMOS‑1 and ATMOS‑2, 73.6% and 80.4% of GT‑treated 
patients rated their axillary sweating as much or moderately better, compared with 
38.2% and 40.6% of vehicle‑treated patients, respectively (Figure 6)

• Following treatment in ATMOS‑1 and ATMOS‑2, more vehicle‑treated patients 
(29.4% and 36.5%, respectively) reported no difference or a little worsening in 
axillary sweating following treatment compared with those receiving GT (8.6% and 
5.4%, respectively) 

Figure 6.  Distribution of Patient Responses to PGIC

VehicleGT

52.3%

17.6%

1

Much Better

21.3% 20.6%

2

Moderately Better

17.8%

32.4%

3

A Little Better

8.1%

24.5%

4

No Difference

0.5%
4.9%

5

A Little Worse

0%0%

6

Moderately Worse

0% 0%

7

Much Worse

VehicleGT
63.7%

26.0%

1

Much Better

16.7% 14.6%

2

Moderately Better

14.2%

22.9%

3

A Little Better

4.9%

32.3%

4

No Difference

0.5%
4.2%

5

A Little Worse

0%0%

6

Moderately Worse

0% 0%

7

Much Worse

80

60

40

20

0

P
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, 
%

ATMOS-1

80

60

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20

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G
IC

, 
%

ATMOS-2

Data are representative of the intent‑to‑treat (ITT) population of patients ≥16 years of age
PCIG Item: Overall, how would you rate your underarm sweating now as compared to before starting the study treatment?
1 (much better), 2 (moderately better), 3 (a little better), 4 (no difference), 5 (a little worse), 6 (moderately worse), 7 (much worse)
GT, topical glycopyrronium tosylate; PCIG, Patient Global Impression of Change

CONCLUSIONS
• After 4 weeks, GT‑treated patients reported greater weekly average 

improvement than vehicle-treated patients on all ASDD items (ie, 
severity, impact, and bother of axillary sweating on daily activities) 
that measured the daily burden of disease associated with axillary 
hyperhidrosis 

• At the end of treatment, fewer GT‑treated patients reported the 
occurrence of the specific negative behaviors or feelings associated 
with their excessive axillary sweating than did vehicle‑treated patients 

• Following treatment, approximately 2‑fold more GT‑treated patients 
rated their axillary sweating as much or moderately better versus 
vehicle-treated patients

• These additional results from ATMOS-1 and ATMOS-2 suggest that 
GT, if approved, has the potential to reduce the burden of disease for 
patients with axillary hyperhidrosis

References
1. Doolittle et al. Arch Dermatol Res. 2016; 308 (10):743‑9. 2. Bahar et al. J Am Acad Dermatol. 
2016; 75(6):1126‑33. 3. Pariser et al. Poster presented at: 25th European Academy of Dermatology 
and Venereology Congress; September 28‑October 2, 2016; Vienna, Austria. 4. Pariser et al. Poster 
presented at: 13th Annual Maui Derm for Dermatologists; March 20-24, 2017; Maui, HI. 

Acknowledgements 
The authors would like to thank Sheri Fehnel, Dana DiBenedetti, and Lauren Nelson, from RTI Health 
Solutions, as well as Diane Ingolia and Christine Conroy, from Dermira, Inc., for their work developing 
the PRO questionnaire. These studies were funded by Dermira, Inc. Medical writing support was 
provided by Prescott Medical Communications Group. All costs associated with development of this 
poster were funded by Dermira, Inc.

Author Disclosures
DMP: Consultant and Investigator for Dermira, Inc. AAH: Consultant for Dermira, Inc.; employee of 
the University of Texas Medical School, Houston, which received compensation from Dermira, Inc. 
for study participation. JD: Employee of Dermira, Inc. JQ: Employee of QST Consultations. DAG: 
Consultant and Investigator for Dermira, Inc. 


	FC17PosterDermiraPariserPatientReportesOutcomesHyperhidrosis.pdf