Trial Outcomes & Findings for Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris (NCT NCT00688064)
NCT ID: NCT00688064
Last Updated: 2021-02-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
459 participants
Primary outcome timeframe
Week 12
Results posted on
2021-02-18
Participant Flow
Recruitment period: 18 AUG 2008 to 14 NOV 2008 in thirty-five centers (30 in the USA and 5 in Canada) public or private practices. Twenty-five USA centers and four Candadian centers used a central IRB, and the others used a local IRB.
Participant milestones
| Measure |
Adapalene-BPO + Doxycycline
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
|
Vehicle + Doxycycline
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
|
|---|---|---|
|
Overall Study
STARTED
|
232
|
227
|
|
Overall Study
COMPLETED
|
211
|
201
|
|
Overall Study
NOT COMPLETED
|
21
|
26
|
Reasons for withdrawal
| Measure |
Adapalene-BPO + Doxycycline
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
|
Vehicle + Doxycycline
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
7
|
|
Overall Study
Lost to Follow-up
|
10
|
10
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Any other reasons
|
1
|
3
|
Baseline Characteristics
Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Adapalene-BPO + Doxycycline
n=232 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
|
Vehicle + Doxycycline
n=227 Participants
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
|
Total
n=459 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
152 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
18.6 years
STANDARD_DEVIATION 5.84 • n=5 Participants
|
18.1 years
STANDARD_DEVIATION 4.92 • n=7 Participants
|
18.4 years
STANDARD_DEVIATION 5.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
170 participants
n=5 Participants
|
164 participants
n=7 Participants
|
334 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
44 participants
n=5 Participants
|
45 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT, LOCF
Outcome measures
| Measure |
Adapalene-BPO + Doxycycline
n=232 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
|
Vehicle + Doxycycline
n=227 Participants
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
|
|---|---|---|
|
Percent Change From Baseline in Total Lesion Counts at Week 12.
|
-64 % of change
Interval -100.0 to 34.0
|
-41 % of change
Interval -92.0 to 64.0
|
SECONDARY outcome
Timeframe: Week 12Population: ITT, LOCF
Outcome measures
| Measure |
Adapalene-BPO + Doxycycline
n=232 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
|
Vehicle + Doxycycline
n=227 Participants
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
|
|---|---|---|
|
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.
|
-72 % of change
Interval -100.0 to 59.0
|
-48 % of change
Interval -93.0 to 79.0
|
SECONDARY outcome
Timeframe: Week 12Population: ITT, LOCF
Outcome measures
| Measure |
Adapalene-BPO + Doxycycline
n=232 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
|
Vehicle + Doxycycline
n=227 Participants
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
|
|---|---|---|
|
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
|
-61 % of change
Interval -100.0 to 81.0
|
-40 % of change
Interval -98.0 to 149.0
|
SECONDARY outcome
Timeframe: Week 12Population: ITT, LOCF
Percentage of subjects graded "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-BPO + Doxycycline
n=232 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
|
Vehicle + Doxycycline
n=227 Participants
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
|
|---|---|---|
|
Success Rate on the Investigator's Global Assessment
|
31.5 % of subjects
|
8.4 % of subjects
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: ITT
Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)
Outcome measures
| Measure |
Adapalene-BPO + Doxycycline
n=232 Participants
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
|
Vehicle + Doxycycline
n=227 Participants
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
|
|---|---|---|
|
Percent of Subjects With Adverse Events
|
26.3 % of subjects
|
26.9 % of subjects
|
Adverse Events
Adapalene-BPO + Doxycycline
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Vehicle + Doxycycline
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adapalene-BPO + Doxycycline
n=232 participants at risk
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
|
Vehicle + Doxycycline
n=227 participants at risk
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
|
|---|---|---|
|
Gastrointestinal disorders
dyspepsia
|
0.86%
2/232 • Number of events 2
|
2.2%
5/227 • Number of events 5
|
|
Infections and infestations
gastroenteritis viral
|
2.2%
5/232 • Number of events 5
|
0.88%
2/227 • Number of events 2
|
|
Infections and infestations
nasopharyngitis
|
4.3%
10/232 • Number of events 10
|
5.7%
13/227 • Number of events 14
|
|
Gastrointestinal disorders
nausea
|
3.9%
9/232 • Number of events 9
|
5.3%
12/227 • Number of events 14
|
|
Infections and infestations
upper respiratory tract infection
|
3.4%
8/232 • Number of events 8
|
2.6%
6/227 • Number of events 6
|
|
Gastrointestinal disorders
vomiting
|
3.9%
9/232 • Number of events 10
|
4.4%
10/227 • Number of events 12
|
Additional Information
Jean-Charles Dhuin, Clinical Project Manager
Galderma
Phone: +33 4 92 95 29 21
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor for review and approval at least 2 months prior to the date of the intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
- Publication restrictions are in place
Restriction type: OTHER