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OpenTrials
Completed

NCT Number: NCT01910064

A Long Term Study of GK530G in Subjects With Acne Vulgaris

This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.

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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, Urayasu, Chiba, Japan

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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 non-inflammatory 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 cyst.
  • 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

Primary outcomes

  1. Local Tolerability (Erythema)

    Time frame: 12 monhths

    Highest severity of Local tolerability scores worth than base line

  2. Local Tolerability (Scaling)

    Time frame: 12 months

    Highest severity of Local tolerability scores worth than base line

  3. Local Tolerability (Dryness)

    Time frame: 12 months

    Highest Severity of Local Tolerability Scores Worse Than Baseline

  4. Local Tolerability (Pruritus)

    Time frame: 12 months

    Highest Severity of Local Tolerability Scores Worse Than Baseline

  5. Local Tolerability (Stinging/Burning)

    Time frame: 12 months

    Highest Severity of Local Tolerability Scores Worse Than Baseline

Secondary outcomes

  1. Percent Changes From Baseline in Total Lesion Counts

    Time frame: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2013
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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