Trial Outcomes & Findings for Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate (NCT NCT00635609)
NCT ID: NCT00635609
Last Updated: 2012-04-20
Results Overview
The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
93 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2012-04-20
Participant Flow
Participant milestones
| Measure |
Doxycycline Hyclate (Doryx) Delayed-release Tablets
Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
|
Doxycycline Hyclate Immediate-release Tablets
Doxycycline hyclate immediate-release tablets, 100 mg once daily
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
45
|
|
Overall Study
COMPLETED
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
Baseline characteristics by cohort
| Measure |
Doxycycline Hyclate (Doryx) Delayed-release Tablets
n=48 Participants
Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
|
Doxycycline Hyclate Immediate-release Tablets
n=45 Participants
Doxycycline hyclate immediate-release tablets, 100 mg once daily
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 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
|
19.3 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
20.9 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
20.1 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
45 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Ethnic Origin
Hispanic
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Ethnic Origin
Not of Hispanic origin
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Race
Asian or Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race
Black
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race
Caucasian
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Race
Other
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksThe Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.
Outcome measures
| Measure |
Doxycycline Hyclate (Doryx) Delayed-release Tablets
n=48 Participants
Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
|
Doxycycline Hyclate Immediate-release Tablets
n=45 Participants
Doxycycline hyclate immediate-release tablets, 100 mg once daily
|
|---|---|---|
|
Successful Outcome According to Investigator's Global Assessment (IGA)
|
18 participants
|
19 participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: intention to treat (ITT)
Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
Outcome measures
| Measure |
Doxycycline Hyclate (Doryx) Delayed-release Tablets
n=48 Participants
Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
|
Doxycycline Hyclate Immediate-release Tablets
n=45 Participants
Doxycycline hyclate immediate-release tablets, 100 mg once daily
|
|---|---|---|
|
Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
|
21.8 acne lesion count
Standard Deviation 13.8
|
26.6 acne lesion count
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: baseline and 12 weeksAcne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
Outcome measures
| Measure |
Doxycycline Hyclate (Doryx) Delayed-release Tablets
n=48 Participants
Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
|
Doxycycline Hyclate Immediate-release Tablets
n=45 Participants
Doxycycline hyclate immediate-release tablets, 100 mg once daily
|
|---|---|---|
|
Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks
|
23.2 Acne lesion count
Standard Deviation 19.3
|
27.6 Acne lesion count
Standard Deviation 20.0
|
Adverse Events
Doxycycline Hyclate (Doryx) Delayed-release Tablets
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Doxycycline Hyclate Immediate-release Tablets
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxycycline Hyclate (Doryx) Delayed-release Tablets
n=48 participants at risk
Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
|
Doxycycline Hyclate Immediate-release Tablets
n=45 participants at risk
Doxycycline hyclate immediate-release tablets, 100 mg once daily
|
|---|---|---|
|
Hepatobiliary disorders
Acute cholecystitis
|
2.1%
1/48 • Number of events 1 • 12 weeks
|
0.00%
0/45 • 12 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.00%
0/48 • 12 weeks
|
2.2%
1/45 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Doxycycline Hyclate (Doryx) Delayed-release Tablets
n=48 participants at risk
Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
|
Doxycycline Hyclate Immediate-release Tablets
n=45 participants at risk
Doxycycline hyclate immediate-release tablets, 100 mg once daily
|
|---|---|---|
|
Nervous system disorders
Headache
|
14.6%
7/48 • Number of events 7 • 12 weeks
|
6.7%
3/45 • Number of events 3 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/48 • 12 weeks
|
8.9%
4/45 • Number of events 4 • 12 weeks
|
|
Injury, poisoning and procedural complications
Sunburn
|
6.2%
3/48 • Number of events 3 • 12 weeks
|
2.2%
1/45 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/48 • 12 weeks
|
6.7%
3/45 • Number of events 3 • 12 weeks
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Phone: 973-442-3376
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60