Trial Outcomes & Findings for Treatment of Moderate to Severe Facial Acne Vulgaris (NCT NCT00612573)
NCT ID: NCT00612573
Last Updated: 2013-04-22
Results Overview
IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory \& inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
257 participants
Primary outcome timeframe
Week 12
Results posted on
2013-04-22
Participant Flow
Recruitment began 4 Mar '08
Participant milestones
| Measure |
Doxycycline 0.6 mg/kg/Day
40 mg doxycycline tablet plus 2 placebo tablets daily
|
Doxycycline 1.2 mg/kg/Day
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
|
Doxycycline 2.4 mg/kg/Day
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
|
Placebo Comparator
3 placebo tablets daily matching active 40 \& 80 mg tablets
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
64
|
65
|
61
|
67
|
|
Overall Study
COMPLETED
|
52
|
51
|
52
|
54
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
9
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Moderate to Severe Facial Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Doxycycline 0.6 mg/kg/Day
n=64 Participants
40 mg doxycycline tablet plus 2 placebo tablets daily
|
Doxycycline 1.2 mg/kg/Day
n=65 Participants
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
|
Doxycycline 2.4 mg/kg/Day
n=61 Participants
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
|
Placebo Comparator
n=67 Participants
3 placebo tablets daily matching active 40 \& 80 mg tablets
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
19.3 years
STANDARD_DEVIATION 5.2 • n=39 Participants
|
19.4 years
STANDARD_DEVIATION 6.6 • n=41 Participants
|
20.7 years
STANDARD_DEVIATION 7.4 • n=35 Participants
|
20.2 years
STANDARD_DEVIATION 7.5 • n=31 Participants
|
19.9 years
STANDARD_DEVIATION 6.7 • n=146 Participants
|
|
Age, Customized
>= 18 years
|
32 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
35 Participants
n=31 Participants
|
133 Participants
n=146 Participants
|
|
Age, Customized
< 18 years
|
32 Participants
n=39 Participants
|
26 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
32 Participants
n=31 Participants
|
124 Participants
n=146 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
35 Participants
n=31 Participants
|
136 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
32 Participants
n=31 Participants
|
121 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=39 Participants
|
65 participants
n=41 Participants
|
61 participants
n=35 Participants
|
67 participants
n=31 Participants
|
257 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT Population
IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory \& inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.
Outcome measures
| Measure |
Doxycycline 0.6 mg/kg/Day
n=64 Participants
40 mg doxycycline tablet plus 2 placebo tablets daily
|
Doxycycline 1.2 mg/kg/Day
n=65 Participants
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
|
Doxycycline 2.4 mg/kg/Day
n=61 Participants
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
|
Placebo Comparator
n=67 Participants
3 placebo tablets daily matching active 40 \& 80 mg tablets
|
|---|---|---|---|---|
|
Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population
|
14.1 Percentage of Participants
Interval 6.6 to 25.0
|
15.4 Percentage of Participants
Interval 7.6 to 26.5
|
29.5 Percentage of Participants
Interval 18.5 to 42.6
|
16.4 Percentage of Participants
Interval 8.5 to 27.5
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: ITT Population
Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.
Outcome measures
| Measure |
Doxycycline 0.6 mg/kg/Day
n=64 Participants
40 mg doxycycline tablet plus 2 placebo tablets daily
|
Doxycycline 1.2 mg/kg/Day
n=65 Participants
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
|
Doxycycline 2.4 mg/kg/Day
n=61 Participants
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
|
Placebo Comparator
n=67 Participants
3 placebo tablets daily matching active 40 \& 80 mg tablets
|
|---|---|---|---|---|
|
Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population
|
8.1 Lesions
Standard Deviation 13.2
|
11.5 Lesions
Standard Deviation 12.1
|
14.0 Lesions
Standard Deviation 19.7
|
7.3 Lesions
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITT Population
Noninflammatory Lesion Count includes open and closed comedones.
Outcome measures
| Measure |
Doxycycline 0.6 mg/kg/Day
n=64 Participants
40 mg doxycycline tablet plus 2 placebo tablets daily
|
Doxycycline 1.2 mg/kg/Day
n=65 Participants
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
|
Doxycycline 2.4 mg/kg/Day
n=61 Participants
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
|
Placebo Comparator
n=67 Participants
3 placebo tablets daily matching active 40 \& 80 mg tablets
|
|---|---|---|---|---|
|
Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population
|
8.5 Lesions
Standard Deviation 19.1
|
5.2 Lesions
Standard Deviation 28.1
|
6.5 Lesions
Standard Deviation 16.2
|
1.8 Lesions
Standard Deviation 31.0
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITT Population
Total Lesion Count is the sum of inflammatory and noninflammatory lesions.
Outcome measures
| Measure |
Doxycycline 0.6 mg/kg/Day
n=64 Participants
40 mg doxycycline tablet plus 2 placebo tablets daily
|
Doxycycline 1.2 mg/kg/Day
n=65 Participants
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
|
Doxycycline 2.4 mg/kg/Day
n=61 Participants
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
|
Placebo Comparator
n=67 Participants
3 placebo tablets daily matching active 40 \& 80 mg tablets
|
|---|---|---|---|---|
|
Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population
|
16.6 Lesions
Standard Deviation 25.6
|
16.8 Lesions
Standard Deviation 32.7
|
20.5 Lesions
Standard Deviation 25.0
|
9.1 Lesions
Standard Deviation 38.1
|
Adverse Events
Doxycycline 0.6 mg/kg/Day
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Doxycycline 1.2 mg/kg/Day
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Doxycycline 2.4 mg/kg/Day
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxycycline 0.6 mg/kg/Day
n=64 participants at risk
40 mg doxycycline tablet plus 2 placebo tablets daily
|
Doxycycline 1.2 mg/kg/Day
n=65 participants at risk
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
|
Doxycycline 2.4 mg/kg/Day
n=61 participants at risk
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
|
Placebo Comparator
n=67 participants at risk
3 placebo tablets daily matching active 40 \& 80 mg tablets
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fracture (Left Radius)
|
0.00%
0/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.5%
1/67 • Number of events 1 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
Other adverse events
| Measure |
Doxycycline 0.6 mg/kg/Day
n=64 participants at risk
40 mg doxycycline tablet plus 2 placebo tablets daily
|
Doxycycline 1.2 mg/kg/Day
n=65 participants at risk
80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
|
Doxycycline 2.4 mg/kg/Day
n=61 participants at risk
160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
|
Placebo Comparator
n=67 participants at risk
3 placebo tablets daily matching active 40 \& 80 mg tablets
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.1%
2/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.6%
1/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.0%
2/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
3/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.1%
2/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.3%
2/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.6%
1/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.5%
1/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.6%
1/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.0%
2/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Skin and subcutaneous tissue disorders
Fungal Infection
|
0.00%
0/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.1%
2/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.3%
2/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Nervous system disorders
Headache
|
9.4%
6/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
6.2%
4/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
6.6%
4/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
7.5%
5/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.3%
2/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.5%
1/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
1.6%
1/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.1%
2/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.3%
2/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.0%
2/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.5%
1/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
13.1%
8/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.0%
2/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
1.6%
1/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.6%
1/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
4.5%
3/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Nervous system disorders
Procedural Pain
|
3.1%
2/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.6%
1/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.0%
2/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Immune system disorders
Seasonal Allergy
|
1.6%
1/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.0%
2/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
6.2%
4/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.6%
1/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.5%
1/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Gastrointestinal disorders
Toothache
|
3.1%
2/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.1%
2/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.5%
1/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
3.1%
2/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.5%
1/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
3.0%
2/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/64 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
1.5%
1/65 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
6.6%
4/61 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
0.00%
0/67 • 4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
|
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