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Completed

NCT Number: NCT02073461

Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.

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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 2

Primary location

Galderma investigational site, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women at the age of 12 or older at the Screening visit.
  • Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion criteria

  • Those with more than two nodular acne lesions or any cysts.
  • Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
  • Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment

Treatment and study plan

CD1579 2.5%

Drug

Other names: Benzoyl Peroxide 2.5%

CD1579 5%

Drug

Other names: Benzoyl Peroxide 5%

Vehicle

Drug

Primary outcomes

  1. Percent Changes From Baseline in Total Lesion Counts

    Time frame: Baseline - Week 12

    Median percent reductions from Baseline in total lesion count (ITT-LOCF)

Secondary outcomes

  1. Percent of Subjects With Adverse Events

    Time frame: up to 12 weeks

    Adverse events which were observed in 5% or more patients with either group are listed.

  2. Local Tolerability (Erythema)

    Time frame: 12 weeks

    Highest severity of local tolerability scores worse than Baseline

  3. Local Tolerability (Scaling)

    Time frame: 12 weeks

    Highest severity of local tolerability scores worse than Baseline

  4. Local Tolerability (Dryness)

    Time frame: 12 weeks

    Highest severity of local tolerability scores worse than Baseline

  5. Local Tolerability (Pruritus)

    Time frame: 12 weeks

    Highest severity of local tolerability scores worse than Baseline

  6. Local Tolerability (Stinging/Burning)

    Time frame: 12 weeks

    Highest severity of local tolerability scores worse than Baseline

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2014
Registry last updated
Mar 28, 2017

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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