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Trial record 60 of 142 for:    acne AND erythema

A Long Term Study of GK530G in Subjects With Acne Vulgaris

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.
ClinicalTrials.gov Identifier: NCT01910064
Recruitment Status : Completed
First Posted : July 29, 2013
Results First Posted : January 5, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: GK530G Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long Term Study of GK530G in Subjects With Acne Vulgaris
Study Start Date : May 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: GK530G
GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
Drug: GK530G
Other Name: Fixed-dose combination gel of Adapalene and Benzoyl Peroxide




Primary Outcome Measures :
  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 Outcome Measures :
  1. Percent Changes From Baseline in Total Lesion Counts [ Time Frame: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12 ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01910064


Locations
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Japan
Galderma investigational site
Urayasu, Chiba, Japan
Galderma investigational site
Kawasaki, Kanagawa, Japan
Galderma investigational site
Yamato, Kanagawa, Japan
Galderma investigational site
Yokohama, Kanagawa, Japan
Galderma investigational site
Kumagaya, Saitama, Japan
Galderma investigational site
Chiyoda, Tokyo, Japan
Galderma investigational site
Koto, Tokyo, Japan
Galderma investigational site
Machida, Tokyo, Japan
Galderma investigational site
Musashino, Tokyo, Japan
Galderma investigational site
Ota, Tokyo, Japan
Galderma investigational site
Shibuya, Tokyo, Japan
Galderma investigational site
Shinjuku, Tokyo, Japan
Galderma investigational site
Suginami, Tokyo, Japan
Galderma investigational site
Tachikawa, Tokyo, Japan
Galderma investigational site
Koto, Tpkyo, Japan
Galderma investigational site
Fukuoka, Japan
Sponsors and Collaborators
Galderma R&D

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01910064     History of Changes
Other Study ID Numbers: RDT.07.SPR.27125
First Posted: July 29, 2013    Key Record Dates
Results First Posted: January 5, 2017
Last Update Posted: March 28, 2017
Last Verified: February 2017

Keywords provided by Galderma R&D:
Acne Vulgaris

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Adapalene
Dermatologic Agents
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