Trial Outcomes & Findings for A Study of Acne Treatment in Children Ages 9 to 11 (NCT NCT00907335)
NCT ID: NCT00907335
Last Updated: 2012-02-15
Results Overview
Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.
COMPLETED
PHASE2
110 participants
Baseline to Week 12
2012-02-15
Participant Flow
Participant milestones
| Measure |
Retin-A Micro
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
Color matched facial gel vehicle control used once daily
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
47
|
54
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
| Measure |
Retin-A Micro
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
Color matched facial gel vehicle control used once daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
A Study of Acne Treatment in Children Ages 9 to 11
Baseline characteristics by cohort
| Measure |
Retin-A Micro
n=55 Participants
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
n=55 Participants
Color matched facial gel vehicle control used once daily
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
9 years
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Age, Customized
10 Years
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Age, Customized
11 Years
|
29 participants
n=5 Participants
|
34 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
Subject Reached Puberty
Yes
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Subject Reached Puberty
No
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Fitzpatrick Score
I
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Fitzpatrick Score
II
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Fitzpatrick Score
III
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Fitzpatrick Score
IV
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Fitzpatrick Score
V
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Fitzpatrick Score
VI
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.
Outcome measures
| Measure |
Retin-A Micro
n=47 Participants
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
n=54 Participants
Color matched facial gel vehicle control used once daily
|
|---|---|---|
|
Change From Baseline in Total Non-inflammatory Lesion Count
|
-19.9 Lesions
Standard Error 4.13
|
-9.7 Lesions
Standard Error 4.42
|
SECONDARY outcome
Timeframe: Baseline to Week 12Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.
Outcome measures
| Measure |
Retin-A Micro
n=47 Participants
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
n=54 Participants
Color matched facial gel vehicle control used once daily
|
|---|---|---|
|
Change From Baseline in Lesion Counts
Comedones
|
-19.85 Lesions
Standard Error 4.13
|
-9.67 Lesions
Standard Error 4.42
|
|
Change From Baseline in Lesion Counts
Inflammatory
|
-0.63 Lesions
Standard Error 1.16
|
0.54 Lesions
Standard Error 1.23
|
|
Change From Baseline in Lesion Counts
Total Lesions
|
-21.87 Lesions
Standard Error 4.64
|
-10.88 Lesions
Standard Error 4.97
|
|
Change From Baseline in Lesion Counts
Open Comedones
|
-4.10 Lesions
Standard Error 1.77
|
-2.86 Lesions
Standard Error 1.87
|
|
Change From Baseline in Lesion Counts
Closed Comedones
|
-15.16 Lesions
Standard Error 2.92
|
-6.09 Lesions
Standard Error 3.14
|
|
Change From Baseline in Lesion Counts
Papules
|
-0.62 Lesions
Standard Error 0.75
|
-0.48 Lesions
Standard Error 0.79
|
|
Change From Baseline in Lesion Counts
Pustules
|
-0.17 Lesions
Standard Error 0.77
|
1.04 Lesions
Standard Error 0.81
|
SECONDARY outcome
Timeframe: Week 12Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.
Outcome measures
| Measure |
Retin-A Micro
n=47 Participants
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
n=54 Participants
Color matched facial gel vehicle control used once daily
|
|---|---|---|
|
Measurement of Success 1
Clear/Almost Clear
|
11 Participants
|
11 Participants
|
|
Measurement of Success 1
At Least 2 Grades Improvement
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 12Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.
Outcome measures
| Measure |
Retin-A Micro
n=47 Participants
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
n=54 Participants
Color matched facial gel vehicle control used once daily
|
|---|---|---|
|
Measurement of Success 2
Clear/Almost Clear
|
10 Participants
|
10 Participants
|
|
Measurement of Success 2
At Least 2 Grades Improvement
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 12Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of "Excellent" or "Good" scores.
Outcome measures
| Measure |
Retin-A Micro
n=47 Participants
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
n=54 Participants
Color matched facial gel vehicle control used once daily
|
|---|---|---|
|
Measurement of Success 3
Success
|
31 Participants
|
27 Participants
|
|
Measurement of Success 3
No Success
|
16 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Participants showing improvement from baseline in the Investigator's Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse.
Outcome measures
| Measure |
Retin-A Micro
n=47 Participants
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
n=54 Participants
Color matched facial gel vehicle control used once daily
|
|---|---|---|
|
Global Assessment
Excellent
|
12 Participants
|
7 Participants
|
|
Global Assessment
Good
|
19 Participants
|
20 Participants
|
|
Global Assessment
Fair
|
11 Participants
|
9 Participants
|
|
Global Assessment
No Change
|
5 Participants
|
18 Participants
|
|
Global Assessment
Worse
|
0 Participants
|
0 Participants
|
Adverse Events
Retin-A Micro
Vehicle Control
Serious adverse events
| Measure |
Retin-A Micro
n=55 participants at risk
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
n=55 participants at risk
Color matched facial gel vehicle control used once daily
|
|---|---|---|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/55 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
1.8%
1/55 • Number of events 1 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
Other adverse events
| Measure |
Retin-A Micro
n=55 participants at risk
Retin-A Micro 0.04% facial acne treatment used once daily
|
Vehicle Control
n=55 participants at risk
Color matched facial gel vehicle control used once daily
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.5%
3/55 • Number of events 3 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
5.5%
3/55 • Number of events 3 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
5.5%
3/55 • Number of events 3 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
0.00%
0/55 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.6%
2/55 • Number of events 2 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
5.5%
3/55 • Number of events 3 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
|
Injury, poisoning and procedural complications
Sunburn
|
7.3%
4/55 • Number of events 4 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
0.00%
0/55 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
23.6%
13/55 • Number of events 13 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
1.8%
1/55 • Number of events 1 • 12 Weeks
Subjects asked if they experienced adverse events at each visit.
|
Additional Information
David Lineberry, Associate Director, Clinical Operations
Valeant Pharmaceuticals International, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60