Trial Outcomes & Findings for Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris (NCT NCT01014689)
NCT ID: NCT01014689
Last Updated: 2021-02-18
Results Overview
Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
378 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-02-18
Participant Flow
Recruitment period 14/08/2009 to 21/01/2010 Type of location: hospital, private hospital and private practice.
Participant milestones
| Measure |
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
191
|
187
|
|
Overall Study
COMPLETED
|
178
|
174
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
|
Overall Study
Pregnancy
|
1
|
0
|
Baseline Characteristics
Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline
n=191 Participants
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
n=187 Participants
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
Total
n=378 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
113 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
215 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
78 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
163 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
18.6 years
STANDARD_DEVIATION 4.7 • n=93 Participants
|
19.1 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
18.9 years
STANDARD_DEVIATION 4.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
169 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
209 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
26 participants
n=93 Participants
|
25 participants
n=4 Participants
|
51 participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
52 participants
n=93 Participants
|
52 participants
n=4 Participants
|
104 participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
18 participants
n=93 Participants
|
17 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
16 participants
n=93 Participants
|
16 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=93 Participants
|
13 participants
n=4 Participants
|
27 participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
15 participants
n=93 Participants
|
18 participants
n=4 Participants
|
33 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=93 Participants
|
17 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
14 participants
n=93 Participants
|
14 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Region of Enrollment
Sweden
|
18 participants
n=93 Participants
|
15 participants
n=4 Participants
|
33 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intention to treat - Last observation carried forward
Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.
Outcome measures
| Measure |
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline
n=191 Participants
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
n=187 Participants
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
|---|---|---|
|
Percent Change From Baseline in Total Lesion Count
|
-74.1 percent of change
Interval -100.0 to 7.7
|
-56.8 percent of change
Interval -97.8 to 73.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intention To treat - Last Observation Carried Forward
Percentage of Subjects "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12.
Outcome measures
| Measure |
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline
n=191 Participants
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
n=187 Participants
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
|---|---|---|
|
Success Rate on the Investigator's Global Assessment (IGA) at Week 12
|
47.6 percent of subjects
|
33.7 percent of subjects
|
Adverse Events
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adapalene 0.1% / BPO 2.5% Gel + Lymecycline
n=191 participants at risk
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline
n=187 participants at risk
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
|
|---|---|---|
|
Nervous system disorders
HEADACHE
|
6.3%
12/191 • Number of events 19 • 12 weeks.
All clinical medical events, occured after Subject's consent signed and during the study, whether observed by the Investigator or reported by the Subject and whether or not thought to be product- or study procedure-related were considered adverse events and collected.
|
9.1%
17/187 • Number of events 23 • 12 weeks.
All clinical medical events, occured after Subject's consent signed and during the study, whether observed by the Investigator or reported by the Subject and whether or not thought to be product- or study procedure-related were considered adverse events and collected.
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.3%
14/191 • Number of events 15 • 12 weeks.
All clinical medical events, occured after Subject's consent signed and during the study, whether observed by the Investigator or reported by the Subject and whether or not thought to be product- or study procedure-related were considered adverse events and collected.
|
4.8%
9/187 • Number of events 10 • 12 weeks.
All clinical medical events, occured after Subject's consent signed and during the study, whether observed by the Investigator or reported by the Subject and whether or not thought to be product- or study procedure-related were considered adverse events and collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure agreement in full force and effect for a period of 10 years.
- Publication restrictions are in place
Restriction type: OTHER