Clinical Trial Results:
A multi-center, randomized, observer-blind trial to compare the irritant potential of the two topical acne formulations Acanya® Gel and Epiduo® Gel on acneic skin in a split-face assessment during a 14-day treatment period

Trial information Top of page
Trial identification
Sponsor protocol code	DPSI-Acanya-P4-03 / 300108BS
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Dow Pharmaceutical Sciences, Inc.
Sponsor organisation address	1330 Redwood Way, Petaluma, United States, 94954-7121
Public contact	Project manager, Dow Pharmaceuticals, +1 707-796-7226,
Scientific contact	Project manager, Dow Pharmaceuticals, +1 707-796-7226,
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	29 Aug 2011
Is this the analysis of the primary completion data?	Yes
Primary completion date	29 Aug 2011
Global end of trial reached?	Yes
Global end of trial date	29 Aug 2011
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	The main objective is to assess the irritant potential of Acanya® Gel compared to Epiduo® Gel on acneic skin
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.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	25 Nov 2010
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	Germany: 21
Worldwide total number of subjects	21
EEA total number of subjects	21
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)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	21
From 65 to 84 years	0
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	-
Pre-assignment
Screening details	Male or female subjects aged 18 years or older were eligible for this clinical trial insofar that they suffered from acne vulgaris in the face.
Period 1
Period 1 title	Treatment (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	No
Arm title	Acanya® Gel
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Acanya® Gel
Investigational medicinal product code
Other name
Pharmaceutical forms	Gel
Routes of administration	Topical use
Dosage and administration details	Applied once daily during the visits by a study nurse over a treatment period of 14 days, to one half of the face.
Arm title	Epiduo® Gel
Arm description	-
Arm type	Active comparator
Investigational medicinal product name	Epiduo® Gel
Investigational medicinal product code
Other name
Pharmaceutical forms	Gel
Routes of administration	Topical use
Dosage and administration details	Applied once daily during the visits by a study nurse over a treatment period of 14 days, to one half of the face.
Arm title	Not corresponding to a specific test field
Arm description	-
Arm type	No intervention
Investigational medicinal product name	No investigational medicinal product assigned in this arm
Number of subjects in period 1 Acanya® Gel Epiduo® Gel Not corresponding to a specific test field Started 21 21 21 Completed 19 19 19 Not completed 2 2 2      Consent withdrawn by subject 2 2 2

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Treatment
Reporting group description	-
Reporting group values Treatment Total Number of subjects 21 21 Age categorical Units: Subjects     In utero 0     Preterm newborn infants (gestational age < 37 wks) 0     Newborns (0-27 days) 0     Infants and toddlers (28 days-23 months) 0     Children (2-11 years) 0     Adolescents (12-17 years) 0     Adults (18-64 years) 0     From 65-84 years 0     85 years and over 0 Age continuous Units: years     arithmetic mean (standard deviation) 21.3 ± 3.3 - Gender categorical Units: Subjects     Female 10 10     Male 11 11 Dryness - Clinical Assessment Units: Score     arithmetic mean (standard deviation) 0.1 ± 0.30 - Erythema - Clinical Assessment Units: Score     arithmetic mean (standard deviation) 0.1 ± 0.36 -

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Acanya® Gel
Reporting group description	-
Reporting group title	Epiduo® Gel
Reporting group description	-
Reporting group title	Not corresponding to a specific test field
Reporting group description	-

End points Top of page

Primary: Dryness - Change in Clinical Assessment at Week 2 Top of page
End point title	Dryness - Change in Clinical Assessment at Week 2 [1]
End point description
End point type	Primary
End point timeframe	2 weeks
Notes [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: One of two treatments was randomly assigned to one side of the face. The other side of the face received the other treatment. The two treated areas were compared to each other. There were 21 subjects in the study.
End point values Acanya® Gel Epiduo® Gel Number of subjects analysed 21 21 Units: Score     arithmetic mean (standard deviation) 0.4 ± 0.75 1.0 ± 0.97
Statistical analysis title	Comparison of treatment groups
Comparison groups	Acanya® Gel v Epiduo® Gel
Number of subjects included in analysis	42
Analysis specification	Pre-specified
Analysis type	superiority [2]
P-value	= 0.0054
Method	Wilcoxon (Mann-Whitney)
Confidence interval
Notes [2] - Note that only 21 subjects are in the analysis. One side of the face was treated with one treatment group and the other side of the face was treated with the other treatment group.

Primary: Dryness - Change in Clinical Assessment at Week 2 Top of page

Primary: Erythema - Change in Clinical Assessment at Week 2 Top of page
End point title	Erythema - Change in Clinical Assessment at Week 2 [3]
End point description
End point type	Primary
End point timeframe	2 weeks
Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: One of two treatments was randomly assigned to one side of the face. The other side of the face received the other treatment. The two treated areas were compared to each other. There were 21 subjects in the study.
End point values Acanya® Gel Epiduo® Gel Number of subjects analysed 21 [4] 21 [5] Units: Score     arithmetic mean (standard deviation) 0.7 ± 0.78 1.3 ± 1.01
Notes [4] - 21 subjects received this treatment on one half of the face. [5] - 21 subjects received this treatment on one half of the face.
Statistical analysis title	Comparison of treatment groups
Comparison groups	Acanya® Gel v Epiduo® Gel
Number of subjects included in analysis	42
Analysis specification	Pre-specified
Analysis type	superiority [6]
P-value	= 0.002
Method	Wilcoxon (Mann-Whitney)
Confidence interval
Notes [6] - Note that only 21 subjects are in the analysis. One side of the face was treated with one treatment group and the other side of the face was treated with the other treatment group.

Primary: Erythema - Change in Clinical Assessment at Week 2 Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	14 days
Assessment type	Non-systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	13.0
Reporting groups
Reporting group title	Acanya® Gel
Reporting group description	-
Reporting group title	Epiduo® Gel
Reporting group description	-
Reporting group title	Not corresponding to a specific test field
Reporting group description	-
Serious adverse events Acanya® Gel Epiduo® Gel Not corresponding to a specific test field Total subjects affected by serious adverse events      subjects affected / exposed 0 / 21 (0.00%) 0 / 21 (0.00%) 0 / 21 (0.00%)      number of deaths (all causes) 0 0 0      number of deaths resulting from adverse events 0 0 0
Frequency threshold for reporting non-serious adverse events: 0%
Non-serious adverse events Acanya® Gel Epiduo® Gel Not corresponding to a specific test field Total subjects affected by non serious adverse events      subjects affected / exposed 0 / 21 (0.00%) 0 / 21 (0.00%) 4 / 21 (19.05%) Nervous system disorders Headache      subjects affected / exposed 0 / 21 (0.00%) 0 / 21 (0.00%) 3 / 21 (14.29%)      occurrences all number 0 0 3 Infections and infestations Nasopharygitis      subjects affected / exposed 0 / 21 (0.00%) 0 / 21 (0.00%) 2 / 21 (9.52%)      occurrences all number 0 0 2 Oral herpes      subjects affected / exposed 0 / 21 (0.00%) 0 / 21 (0.00%) 1 / 21 (4.76%)      occurrences all number 0 0 1

Adverse events Top of page

More information Top of page
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

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