Trial Outcomes & Findings for Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne (NCT NCT01474590)
NCT ID: NCT01474590
Last Updated: 2021-02-18
Results Overview
Overall success is reached when the 2 following criteria are fulfilled : 1. Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment 2. Safe treatment: Absence of any listed safety issues
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
266 participants
Primary outcome timeframe
20 weeks
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
Epiduo/Tactuo + Doxycycline 200mg
Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
|
Isotretinoin + Vehicle Gel
Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
133
|
|
Overall Study
COMPLETED
|
105
|
116
|
|
Overall Study
NOT COMPLETED
|
28
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
Baseline characteristics by cohort
| Measure |
Epiduo/Tactuo + Doxycycline 200mg
n=133 Participants
Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
|
Isotretinoin + Vehicle Gel
n=133 Participants
Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.5 years
STANDARD_DEVIATION 5.0 • n=93 Participants
|
19.3 years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
19.4 years
STANDARD_DEVIATION 4.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
227 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
133 count of participants
n=93 Participants
|
133 count of participants
n=4 Participants
|
266 count of participants
n=27 Participants
|
|
IGA
4
|
118 count of participants
n=93 Participants
|
115 count of participants
n=4 Participants
|
233 count of participants
n=27 Participants
|
|
IGA
5
|
15 count of participants
n=93 Participants
|
18 count of participants
n=4 Participants
|
33 count of participants
n=27 Participants
|
|
nodule counts
|
8.0 nodules
STANDARD_DEVIATION 3.6 • n=93 Participants
|
7.6 nodules
STANDARD_DEVIATION 2.5 • n=4 Participants
|
7.8 nodules
STANDARD_DEVIATION 3.1 • n=27 Participants
|
PRIMARY outcome
Timeframe: 20 weeksOverall success is reached when the 2 following criteria are fulfilled : 1. Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment 2. Safe treatment: Absence of any listed safety issues
Outcome measures
| Measure |
Epiduo/Tactuo + Doxycycline 200mg
n=133 Participants
Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
|
Isotretinoin + Vehicle Gel
n=133 Participants
Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
|
|---|---|---|
|
The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
|
85 count of participants
|
73 count of participants
|
Adverse Events
Epiduo/Tactuo + Doxycycline 200mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Isotretinoin + Vehicle Gel
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epiduo/Tactuo + Doxycycline 200mg
n=133 participants at risk
Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
|
Isotretinoin + Vehicle Gel
n=133 participants at risk
Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/133 • 20 weeks
|
0.75%
1/133 • Number of events 1 • 20 weeks
|
Other adverse events
| Measure |
Epiduo/Tactuo + Doxycycline 200mg
n=133 participants at risk
Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.
|
Isotretinoin + Vehicle Gel
n=133 participants at risk
Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
dry skin
|
18.8%
25/133 • Number of events 31 • 20 weeks
|
32.3%
43/133 • Number of events 56 • 20 weeks
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
10.5%
14/133 • Number of events 17 • 20 weeks
|
5.3%
7/133 • Number of events 8 • 20 weeks
|
|
Nervous system disorders
headache
|
9.0%
12/133 • Number of events 14 • 20 weeks
|
8.3%
11/133 • Number of events 12 • 20 weeks
|
|
Gastrointestinal disorders
lip dry
|
6.8%
9/133 • Number of events 9 • 20 weeks
|
49.6%
66/133 • Number of events 72 • 20 weeks
|
|
Gastrointestinal disorders
nausea
|
10.5%
14/133 • Number of events 14 • 20 weeks
|
3.8%
5/133 • Number of events 5 • 20 weeks
|
|
Gastrointestinal disorders
vomiting
|
9.0%
12/133 • Number of events 14 • 20 weeks
|
1.5%
2/133 • Number of events 2 • 20 weeks
|
|
Infections and infestations
naospharyngitis
|
11.3%
15/133 • Number of events 17 • 20 weeks
|
10.5%
14/133 • Number of events 17 • 20 weeks
|
|
Infections and infestations
UPTRI (Upper Tract Respiratory Infection)
|
6.8%
9/133 • Number of events 10 • 20 weeks
|
9.8%
13/133 • Number of events 16 • 20 weeks
|
|
Gastrointestinal disorders
cheilitis
|
1.5%
2/133 • Number of events 2 • 20 weeks
|
24.1%
32/133 • Number of events 33 • 20 weeks
|
Additional Information
Dr. Jerry Tan
University of Western Ontario and Windsor Clinical Research Inc., 2224 Walker Rd. Suite 300, Windsor, ON, Canada
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER