Clinical Trial Results:
A Phase 4 Open-Label Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-110 Gel (ACANYA™ Gel) in Subjects with Acne Vulgaris
Summary
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EudraCT number |
2010-022678-15 |
Trial protocol |
DE |
Global end of trial date |
02 Oct 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jan 2020
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First version publication date |
04 Jan 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
DPSI IDP-110-P4 01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Dow Pharmaceutical Sciences, Inc
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Sponsor organisation address |
1330 Redwood Way, Petaluma, United States, 94954-7121
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Public contact |
Clinical Trial Manager, Dow Pharmaceuticals, 707 793-2600,
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Scientific contact |
Clinical Trial Manager, Dow Pharmaceuticals, 707 793-2600,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Oct 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Oct 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Oct 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the safety, systemic exposure and pharmacokinetics of clindamycin in IDP-110 Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) in subjects with moderate or severe acne vulgaris during once daily topical application of IDP-110 Gel for 30 days.
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Protection of trial subjects |
The clinical trial was performed in accordance with the currently valid declaration of Helsinki as
well as German regulations. The ICH guideline for GCP (January 1997) was observed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Jan 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 3
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Country: Number of subjects enrolled |
United States: 20
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Worldwide total number of subjects |
23
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EEA total number of subjects |
3
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
23
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
Ten to 11 male or female Caucasian and 5 to 6 male or female non-Caucasian subjects aged 18 years or older who met the inclusion criteria were to be enrolled in this study. | ||||||
Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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IDP-110 Gel | ||||||
Arm description |
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Arm type |
Experimental | ||||||
Investigational medicinal product name |
ACANYA® Gel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Topical use
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Dosage and administration details |
applied once a day for 30 days
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: There were 23 subjects enrolled and 16 subjects treated. |
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Baseline characteristics reporting groups
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Reporting group title |
IDP-110 Gel
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IDP-110 Gel
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Reporting group description |
- |
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End point title |
Maximum concentration at Day 30 [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
30 days
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical analyses were conducted for this study. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
30 days
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14
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Reporting groups
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Reporting group title |
IDP-110 Gel
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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23 Dec 2010 |
Required statement of the EC was included that ACANYA™ Gel had no marketing authorization in Germany. Furthermore, the name of the Chief Medical Officer had changed. |
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27 Jul 2011 |
To include the investigative site in the United States. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |