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

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ClinicalTrials.gov Identifier: NCT00599521

Recruitment Status : Completed

First Posted : January 23, 2008

Results First Posted : April 19, 2011

Last Update Posted : April 19, 2011

Sponsor:

Information provided by:

Galderma

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Acne Vulgaris
Interventions	Drug: Adapalene lotion 0.1% Drug: Adapalene Lotion Vehicle
Enrollment	1067

Participant Flow

Recruitment Details	Multi center study recruitment period: First subject enrolled Nov 6, 2007; last subject completed Nov 14, 2008
Pre-assignment Details	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.


Arm/Group Title	Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%
Arm/Group Description	once a day for 12 weeks	once a day for 12 weeks
Arm/Group Description	once a day for 12 weeks	once a day for 12 weeks
Period Title: Overall Study
Started	535	531
Completed	475	462
Not Completed	60	69
Reason Not Completed
Lack of Efficacy	4	8
Adverse Event	4	1
Withdrawal by Subject	28	34
Protocol Violation	1	1
Lost to Follow-up	23	23
Pregnancy	0	2

Baseline Characteristics

Arm/Group Title		Adapalene Lotion 0.1%	Adapalene Lotion Vehicle 0%	Total
Arm/Group Description		once a day for 12 weeks	once a day for 12 weeks	Total of all reporting groups
Arm/Group Description		once a day for 12 weeks	once a day for 12 weeks	Total of all reporting groups
Overall Number of Baseline Participants		535	531	1066
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	535 participants	531 participants	1066 participants
	<=18 years	338 63.2%	336 63.3%	674 63.2%
	Between 18 and 65 years	197 36.8%	195 36.7%	392 36.8%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	535 participants	531 participants	1066 participants
		19.1 (6.8)	19.2 (7.3)	19.15 (7.05)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	535 participants	531 participants	1066 participants
	Female	300 56.1%	272 51.2%	572 53.7%
	Male	235 43.9%	259 48.8%	494 46.3%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	535 participants	531 participants	1066 participants
United States		487	484	971
Canada		48	47	95

Outcome Measures

1.Primary Outcome


Title	Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12
Description	Success defined as percentage of subjects who achieved at least a two-...
Description	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.
Time Frame	From Baseline to Week 12

Outcome Measure Data