Clinical Trial Results:
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED EFFICACY AND SAFETY STUDY OF DRM04 IN SUBJECTS WITH AXILLARY HYPERHIDROSIS
Summary
|
|
EudraCT number |
2015-002052-27 |
Trial protocol |
DE |
Global end of trial date |
31 Mar 2016
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
24 Apr 2017
|
First version publication date |
24 Apr 2017
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
DRM04-HH04
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02530281 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Dermira, Inc.
|
||
Sponsor organisation address |
275 Middlefield Road, Ste 150, Menlo Park, United States, 94025
|
||
Public contact |
Eugene A. Bauer, M.D.
Chief Medical Officer, Dermira, Inc., 001 650421-7202, eugene.bauer@dermira.com
|
||
Scientific contact |
Eugene A. Bauer, M.D.
Chief Medical Officer, Dermira, Inc., 001 650421-7202, eugene.bauer@dermira.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
31 Mar 2016
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
31 Mar 2016
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
31 Mar 2016
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
The objective of this study will be to assess the efficacy and safety of DRM04 Topical Wipes, 3.75% compared to vehicle when applied once daily for 28 days in subjects with primary axillary hyperhidrosis.
|
||
Protection of trial subjects |
This study was conducted in accordance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Jul 2015
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United States: 291
|
||
Country: Number of subjects enrolled |
Germany: 53
|
||
Worldwide total number of subjects |
344
|
||
EEA total number of subjects |
53
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
2
|
||
Adolescents (12-17 years) |
21
|
||
Adults (18-64 years) |
316
|
||
From 65 to 84 years |
5
|
||
85 years and over |
0
|
|
||||||||||||||||||||||||||||
Recruitment
|
||||||||||||||||||||||||||||
Recruitment details |
- | |||||||||||||||||||||||||||
Pre-assignment
|
||||||||||||||||||||||||||||
Screening details |
Screening: maximum duration of 35 days | |||||||||||||||||||||||||||
Period 1
|
||||||||||||||||||||||||||||
Period 1 title |
Overall trial (overall period)
|
|||||||||||||||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||||||||||||||
Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||||||||||||||||||||
Arms
|
||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||||||||||||||
Arm title
|
DRM04, 3.75% | |||||||||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
DRM04, 3.75%
|
|||||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||||
Pharmaceutical forms |
Cutaneous solution
|
|||||||||||||||||||||||||||
Routes of administration |
Topical use
|
|||||||||||||||||||||||||||
Dosage and administration details |
DRM04 3.75% solution applied once daily to the axillae for 28 days
|
|||||||||||||||||||||||||||
Arm title
|
Vehicle | |||||||||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||
Investigational medicinal product name |
Vehicle
|
|||||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||||
Pharmaceutical forms |
Cutaneous solution
|
|||||||||||||||||||||||||||
Routes of administration |
Topical use
|
|||||||||||||||||||||||||||
Dosage and administration details |
Vehicle solution applied once daily to the axillae for 28 days
|
|||||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall trial
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
DRM04, 3.75% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
DRM04, 3.75%
|
||
Reporting group description |
- | ||
Reporting group title |
Vehicle
|
||
Reporting group description |
- |
|
||||||||||
End point title |
Proportion of Subjects with a Minimum 4-Point Improvement in Weekly Mean Score of ASDD Item #2, from Baseline at Week 4 | |||||||||
End point description |
||||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
Baseline - Week 4
|
|||||||||
|
||||||||||
Statistical analysis title |
Co-primary | |||||||||
Comparison groups |
DRM04, 3.75% v Vehicle
|
|||||||||
Number of subjects included in analysis |
344
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
other | |||||||||
P-value |
< 0.001 | |||||||||
Method |
Cochran-Mantel-Haenszel | |||||||||
Confidence interval |
|
|||||||||||||
End point title |
Absolute Change in Gravimetrically-Measured Sweat Production at Week 4 | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline - Week 4
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Co-primary | ||||||||||||
Comparison groups |
Vehicle v DRM04, 3.75%
|
||||||||||||
Number of subjects included in analysis |
344
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.065 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Absolute Change in Gravimetrically-Measured Sweat Production at Week 4, Excluding Analysis Center 14 (Investigational Sites 412 and 419) | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline - Week 4
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Sensitivity analysis | ||||||||||||
Comparison groups |
DRM04, 3.75% v Vehicle
|
||||||||||||
Number of subjects included in analysis |
330
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.001 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Confidence interval |
|
||||||||||
End point title |
Proportion of Subjects with a Minimum 2-grade Improvement in HDSS from Baseline at Week 4 | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Baseline - Week 4
|
|||||||||
|
||||||||||
Statistical analysis title |
Secondary | |||||||||
Comparison groups |
Vehicle v DRM04, 3.75%
|
|||||||||
Number of subjects included in analysis |
344
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
other | |||||||||
P-value |
< 0.001 | |||||||||
Method |
Cochran-Mantel-Haenszel | |||||||||
Confidence interval |
|
||||||||||
End point title |
Proportion of Subjects who have at least a 50% reduction in Gravimetrically-Measured Sweat Production from Baseline at Week 4 | |||||||||
End point description |
||||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Baseline - Week 4
|
|||||||||
|
||||||||||
Statistical analysis title |
Secondary | |||||||||
Comparison groups |
DRM04, 3.75% v Vehicle
|
|||||||||
Number of subjects included in analysis |
344
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
other | |||||||||
P-value |
< 0.001 | |||||||||
Method |
Cochran-Mantel-Haenszel | |||||||||
Confidence interval |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Baseline - end of study
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
DRM04, 3.75%
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Vehicle
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |