Trial Outcomes & Findings for Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1% (NCT NCT00598832)
NCT ID: NCT00598832
Last Updated: 2021-02-18
Results Overview
Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1075 participants
Primary outcome timeframe
From Baseline to Week 12
Results posted on
2021-02-18
Participant Flow
Multi center study recruitment period: First subject enrolled Nov 7, 2007; last subject completed Nov 6, 2008
Washout requirements: 2 weeks for systemic anti-inflammatory drugs, 4 weeks for oral antibiotics, 2 months for inhaled/nasal steroids and 6 months for hormonal contraceptives/therapies.
Participant milestones
| Measure |
Adapalene Lotion 0.1%
once a day for 12 weeks
|
Adapalene Lotion Vehicle 0%
once a day for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
533
|
542
|
|
Overall Study
COMPLETED
|
471
|
460
|
|
Overall Study
NOT COMPLETED
|
62
|
82
|
Reasons for withdrawal
| Measure |
Adapalene Lotion 0.1%
once a day for 12 weeks
|
Adapalene Lotion Vehicle 0%
once a day for 12 weeks
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
7
|
|
Overall Study
Adverse Event
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
25
|
36
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
24
|
29
|
|
Overall Study
Pregnancy
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
4
|
|
Overall Study
Non compliance
|
1
|
0
|
Baseline Characteristics
Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
Baseline characteristics by cohort
| Measure |
Adapalene Lotion 0.1%
n=533 Participants
once a day for 12 weeks
|
Adapalene Lotion Vehicle 0%
n=542 Participants
once a day for 12 weeks
|
Total
n=1075 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
327 Participants
n=5 Participants
|
343 Participants
n=7 Participants
|
670 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
206 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
405 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
|
19.5 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
18.9 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
19.2 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
283 Participants
n=5 Participants
|
290 Participants
n=7 Participants
|
573 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
250 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
502 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
463 participants
n=5 Participants
|
468 participants
n=7 Participants
|
931 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
70 participants
n=5 Participants
|
74 participants
n=7 Participants
|
144 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 12Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.
Outcome measures
| Measure |
Adapalene Lotion 0.1%
n=533 Participants
once a day for 12 weeks
|
Adapalene Lotion Vehicle 0%
n=542 Participants
once a day for 12 weeks
|
|---|---|---|
|
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
|
26.3 Percentage of Participants
|
17.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Outcome measures
| Measure |
Adapalene Lotion 0.1%
n=533 Participants
once a day for 12 weeks
|
Adapalene Lotion Vehicle 0%
n=542 Participants
once a day for 12 weeks
|
|---|---|---|
|
Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12
|
36.7 Absolute Change in Total Lesion Count
Standard Error 1.0
|
25.5 Absolute Change in Total Lesion Count
Standard Error 1.0
|
PRIMARY outcome
Timeframe: Baseline to Week 12Outcome measures
| Measure |
Adapalene Lotion 0.1%
n=533 Participants
once a day for 12 weeks
|
Adapalene Lotion Vehicle 0%
n=542 Participants
once a day for 12 weeks
|
|---|---|---|
|
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12
|
14.3 Absolute Change in Infl Lesion count
Standard Error 0.4
|
10.2 Absolute Change in Infl Lesion count
Standard Error 0.4
|
PRIMARY outcome
Timeframe: Baseline to Week 12Outcome measures
| Measure |
Adapalene Lotion 0.1%
n=533 Participants
once a day for 12 weeks
|
Adapalene Lotion Vehicle 0%
n=542 Participants
once a day for 12 weeks
|
|---|---|---|
|
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12
|
22.4 Absolute Change in Non-Infl Lesion count
Standard Error 0.8
|
15.3 Absolute Change in Non-Infl Lesion count
Standard Error 0.7
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Percent change in lesion count from baseline to week 12
Outcome measures
| Measure |
Adapalene Lotion 0.1%
n=533 Participants
once a day for 12 weeks
|
Adapalene Lotion Vehicle 0%
n=542 Participants
once a day for 12 weeks
|
|---|---|---|
|
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Total lesion count
|
-51.5 % Change in Lesion Count
Standard Deviation 29.6
|
-37.1 % Change in Lesion Count
Standard Deviation 34.2
|
|
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Inflammatory
|
-54.9 % Change in Lesion Count
Standard Deviation 31.9
|
-40.3 % Change in Lesion Count
Standard Deviation 40.7
|
|
Mean Percent Change in Total Lesion Count From Baseline to Week 12
Non-Inflammatory
|
-49.6 % Change in Lesion Count
Standard Deviation 34.0
|
-35.7 % Change in Lesion Count
Standard Deviation 38.0
|
Adverse Events
Adapalene Lotion 0.1%
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Adapalene Lotion Vehicle 0%
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adapalene Lotion 0.1%
n=533 participants at risk
once a day for 12 weeks
|
Adapalene Lotion Vehicle 0%
n=542 participants at risk
once a day for 12 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.19%
1/533 • Number of events 1
|
0.00%
0/542
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.19%
1/533 • Number of events 1
|
0.00%
0/542
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/533
|
0.18%
1/542 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/533
|
0.18%
1/542 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.19%
1/533 • Number of events 1
|
0.00%
0/542
|
Other adverse events
| Measure |
Adapalene Lotion 0.1%
n=533 participants at risk
once a day for 12 weeks
|
Adapalene Lotion Vehicle 0%
n=542 participants at risk
once a day for 12 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.4%
50/533 • Number of events 50
|
3.9%
21/542 • Number of events 21
|
Additional Information
Michael Graeber MD/ Head of Global Clinical Project Management
Galderma
Phone: 609-860-8201
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee disclosure restriction varies per institutional request/agreement
- Publication restrictions are in place
Restriction type: OTHER