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Completed

NCT Number: NCT02073448

Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.

This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the treatment of acne vulgaris for up to 12 weeks, 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 3

Primary location

Galderma investigational site, Chitose, Hokkaido, 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

GK530G

Drug

Other names: Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

CD0271

Drug

Other names: Adapalene 0.1% Gel

CD1579

Drug

Other names: Benzoyl Peroxide 2.5% Gel

Primary outcomes

  1. Percent Changes From Baseline in Total Lesion Counts

    Time frame: Baseline - Week12

Secondary outcomes

  1. Percent of Subjects With Adverse Events

    Time frame: up to 12 weeks

  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, Active-controlled Parallel Group Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel 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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