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

This study has been completed.

Sponsor:

Information provided by:

Galderma

ClinicalTrials.gov Identifier:

NCT00598832

First received: January 11, 2008

Last updated: March 21, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 11, 2008
Last Updated Date	March 21, 2011
Start Date ^ICMJE	November 2007
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 21, 2011)	Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ] 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. Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ] Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ] Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: January 11, 2008)	Percent of subjects who have at least a 2 point reduction at week 12 in the IGA score from baseline, and absolute change from baseline to week 12 in inflammatory, non-inflammatory, and total lesion counts. [ Time Frame: 1 wk, 2 wks, 4 wks, 8 wks, and 12 wks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00598832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 21, 2011)	Mean Percent Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ] Percent change in lesion count from baseline to week 12
Original Secondary Outcome Measures ^ICMJE (submitted: January 11, 2008)	Percent change from baseline to week 12 in inflammatory, non-inflammatory, and total lesion counts. [ Time Frame: 1 wk, 2 wks, 4 wks, 8 wks, and 12 wks ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
Official Title ^ICMJE	A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Demonstrate the Efficacy and Safety of Adapalene Lotion, 0.1% Compared With Vehicle Lotion in Subjects With Acne Vulgaris
Brief Summary	The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.
Detailed Description	This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Acne Vulgaris
Intervention ^ICMJE	Drug: Adapalene lotion 0.1% Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks Drug: Adapalene Lotion Vehicle Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks
Study Arm (s)	Experimental: Adapalene lotion 0.1% Intervention: Drug: Adapalene lotion 0.1% Placebo Comparator: Adapalene Lotion vehicle Intervention: Drug: Adapalene Lotion Vehicle
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1075
Completion Date	November 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects with Moderate or Severe Acne Vulgaris, 20-50 papules and pustules in total on the face excluding the nose 30-100 non-inflammatory lesions on the face excluding the nose. Negative urine pregnancy test for all females. Exclusion Criteria: Subjects with more than one acne nodule. Subjects with any acne cyst on the face. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment. Subjects with underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy, such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. Subjects who are pregnant, nursing, or planning a pregnancy.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00598832
Other Study ID Numbers ^ICMJE	RD.06.SPR.18113, IND 076057
Has Data Monitoring Committee	No
Responsible Party	Marie Ciardella Clinical Trials.gov Administrator, Galderma
Study Sponsor ^ICMJE	Galderma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Galderma
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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