Trial Outcomes & Findings for Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1% (NCT NCT00599521)

NCT ID: NCT00599521

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: 1067 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 6, 2007; last subject completed Nov 14, 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	535	531
Overall Study COMPLETED	475	462
Overall Study NOT COMPLETED	60	69

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	4	8
Overall Study Adverse Event	4	1
Overall Study Withdrawal by Subject	28	34
Overall Study Protocol Violation	1	1
Overall Study Lost to Follow-up	23	23
Overall Study Pregnancy	0	2

Baseline Characteristics

Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

Baseline characteristics by cohort

Measure	Adapalene Lotion 0.1% n=535 Participants once a day for 12 weeks	Adapalene Lotion Vehicle 0% n=531 Participants once a day for 12 weeks	Total n=1066 Participants Total of all reporting groups
Age, Categorical <=18 years	338 Participants n=5 Participants	336 Participants n=7 Participants	674 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	197 Participants n=5 Participants	195 Participants n=7 Participants	392 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	19.1 years STANDARD_DEVIATION 6.8 • n=5 Participants	19.2 years STANDARD_DEVIATION 7.3 • n=7 Participants	19.15 years STANDARD_DEVIATION 7.05 • n=5 Participants
Sex: Female, Male Female	300 Participants n=5 Participants	272 Participants n=7 Participants	572 Participants n=5 Participants
Sex: Female, Male Male	235 Participants n=5 Participants	259 Participants n=7 Participants	494 Participants n=5 Participants
Region of Enrollment United States	487 participants n=5 Participants	484 participants n=7 Participants	971 participants n=5 Participants
Region of Enrollment Canada	48 participants n=5 Participants	47 participants n=7 Participants	95 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 12

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.

Outcome measures

Measure	Adapalene Lotion 0.1% n=535 Participants once a day for 12 weeks	Adapalene Lotion Vehicle 0% n=531 Participants once a day for 12 weeks
Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12	24.1 Percentage of Participants	16.4 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Outcome measures

Measure	Adapalene Lotion 0.1% n=535 Participants once a day for 12 weeks	Adapalene Lotion Vehicle 0% n=531 Participants once a day for 12 weeks
Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12	32.5 Absolute Change in Total Lesion Count Standard Error 1.0	23.3 Absolute Change in Total Lesion Count Standard Error 1.0

PRIMARY outcome

Timeframe: Baseline to Week 12

Outcome measures

Measure	Adapalene Lotion 0.1% n=535 Participants once a day for 12 weeks	Adapalene Lotion Vehicle 0% n=531 Participants once a day for 12 weeks
Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12	13.0 Absolute Change in Infl Lesion count Standard Error 0.5	10.4 Absolute Change in Infl Lesion count Standard Error 0.5

PRIMARY outcome

Timeframe: Baseline to Week 12

Outcome measures

Measure	Adapalene Lotion 0.1% n=535 Participants once a day for 12 weeks	Adapalene Lotion Vehicle 0% n=531 Participants once a day for 12 weeks
Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12	19.5 Absolute Change in Non-Infl Lesion Standard Error 0.8	12.9 Absolute Change in Non-Infl Lesion Standard Error 0.8

SECONDARY outcome

Timeframe: From Baseline to 12 weeks

Percent change in lesion count from baseline to week 12

Outcome measures

Measure	Adapalene Lotion 0.1% n=535 Participants once a day for 12 weeks	Adapalene Lotion Vehicle 0% n=531 Participants once a day for 12 weeks
Mean Percent Change in Total Lesion Count From Baseline to Week 12 Total lesion count	-44.6 % Change in Lesion Count Standard Deviation 33.2	-32.8 % Change in Lesion Count Standard Deviation 34.1
Mean Percent Change in Total Lesion Count From Baseline to Week 12 Inflammatory	-46.0 % Change in Lesion Count Standard Deviation 36.8	-36.9 % Change in Lesion Count Standard Deviation 40.7
Mean Percent Change in Total Lesion Count From Baseline to Week 12 Non-Inflammatory	-43.1 % Change in Lesion Count Standard Deviation 40.9	-30.2 % Change in Lesion Count Standard Deviation 40.5

Adverse Events

Adapalene Lotion 0.1%

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Adapalene Lotion Vehicle 0%

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Adapalene Lotion 0.1% n=535 participants at risk once a day for 12 weeks	Adapalene Lotion Vehicle 0% n=531 participants at risk once a day for 12 weeks
Skin and subcutaneous tissue disorders Dry Skin	6.0% 32/535 • Number of events 33	2.1% 11/531 • Number of events 11

Additional Information

Michael Graeber MD/ Head of Global Clinical Project Management

Galderma

Phone: 609-860-8201

Email: michael.graeber@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee disclosure restriction varies per institutional request/agreement
• Publication restrictions are in place

Restriction type: OTHER