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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598832
First Posted: January 23, 2008
Last Update Posted: April 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Galderma
  Purpose
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Condition Intervention Phase
Acne Vulgaris Drug: Adapalene lotion 0.1% Drug: Adapalene Lotion Vehicle Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • 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 Count From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
  • 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 ]

Secondary Outcome Measures:
  • Mean Percent Change in Total Lesion Count From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ]
    Percent change in lesion count from baseline to week 12


Enrollment: 1075
Study Start Date: November 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adapalene lotion 0.1% Drug: Adapalene lotion 0.1%
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
Placebo Comparator: Adapalene Lotion vehicle Drug: Adapalene Lotion Vehicle
Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598832


  Show 34 Study Locations
Sponsors and Collaborators
Galderma
  More Information

Responsible Party: Marie Ciardella Clinical Trials.gov Administrator, Galderma
ClinicalTrials.gov Identifier: NCT00598832     History of Changes
Other Study ID Numbers: RD.06.SPR.18113
IND 076057
First Submitted: January 11, 2008
First Posted: January 23, 2008
Results First Submitted: April 16, 2010
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011
Last Verified: March 2011

Keywords provided by Galderma:
Acne Vulgaris
Adapalene

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents