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

• ClinicalTrials.gov Identifier: NCT00599521
• Recruitment Status: Completed
• First Posted: January 23, 2008
• Results First Posted: April 19, 2011
• Last Update Posted: February 18, 2021
• Sponsor: Galderma R&D
• Information provided by: Galderma R&D

Tracking Information

• First Submitted Date: January 11, 2008
• First Posted Date: January 23, 2008
• Results First Submitted Date: April 16, 2010
• Results First Posted Date: April 19, 2011
• Last Update Posted Date: February 18, 2021
• Study Start Date: November 2007
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 ]
  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 Counts From Baseline to Week 12 [ Time Frame: Baseline to 12 weeks ]
• Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
• Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]

• Original Primary Outcome Measures (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 ]

Current Secondary Outcome Measures (submitted: March 21, 2011)

Mean Percent Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: From Baseline to 12 weeks ]

Percent change in lesion count from baseline to week 12

• Original Secondary Outcome Measures (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 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• 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
  Vehicle will be applied topically to the face, once a day, for 12 weeks

Study Arms

• Experimental: Adapalene lotion 0.1%
  Intervention: Drug: Adapalene lotion 0.1%
• Placebo Comparator: Adapalene Lotion vehicle
  Intervention: Drug: Adapalene Lotion Vehicle

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 15, 2008): 1067
• Original Estimated Enrollment (submitted: January 11, 2008): 1066
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00599521
• Other Study ID Numbers: RD.06.SPR.18114; IND 076057
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Marie Ciardella Clinical Trials.gov Administrator, Galderma Laboratories, Inc
• Original Responsible Party: Barry M. Calvarese, Vice President Regulatory and Clinical Affairs, Dow Pharmaceutical Sciences, Inc.
• Current Study Sponsor: Galderma R&D
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Galderma R&D
• Verification Date: March 2011