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Completed

NCT Number: NCT00598832

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

The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Dermatology Centre, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adapalene lotion 0.1%

Drug

Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks

Adapalene Lotion Vehicle

Drug

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

Primary outcomes

  1. 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.

  2. Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12

    Time frame: Baseline to Week 12

  3. Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12

    Time frame: Baseline to Week 12

  4. Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12

    Time frame: Baseline to Week 12

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 23, 2008
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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