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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma R&D
ClinicalTrials.gov Identifier:
NCT02073448
First received: February 20, 2014
Last updated: February 27, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Acne Vulgaris Drug: GK530G Drug: CD0271 Drug: CD1579 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Galderma R&D:

Primary Outcome Measures:
  • Percent Changes From Baseline in Total Lesion Counts [ Time Frame: Baseline - Week12 ]

Secondary Outcome Measures:
  • Percent of Subjects With Adverse Events [ Time Frame: up to 12 weeks ]
  • Local Tolerability (Erythema) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  • Local Tolerability (Scaling) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  • Local Tolerability (Dryness) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  • Local Tolerability (Pruritus) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline

  • Local Tolerability (Stinging/Burning) [ Time Frame: 12 weeks ]
    Highest severity of local tolerability scores worse than Baseline


Enrollment: 417
Study Start Date: March 2014
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GK530G
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Drug: GK530G
Other Name: Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Active Comparator: CD0271
Adapalene 01% Gel
Drug: CD0271
Other Name: Adapalene 0.1% Gel
Active Comparator: CD1579
Benzoyl Peroxide 2.5% Gel
Drug: CD1579
Other Name: Benzoyl Peroxide 2.5% Gel

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073448

Locations
Japan
Galderma investigational site
Chitose, Hokkaido, Japan
Galderma investigational site
Kitami, Hokkaido, Japan
Galderma investigational site
Sapporo, Hokkaido, Japan
Galderma investigational site
Yokohama, Kanagawa, Japan
Galderma investigational site
Kurashiki, Okayama, Japan
Galderma investigational site
Daito, Osaka, Japan
Galderma investigational site
Neyagawa, Osaka, Japan
Galderma investigational site
Sakai, Osaka, Japan
Galderma investigational site
Adachi, Tokyo, Japan
Galderma investigational site
Setagaya, Tokyo, Japan
Galderma investigational site
Kagoshima, Japan
Galderma investigational site
Osaka, Japan
Galderma investigational site
Saitama, Japan
Sponsors and Collaborators
Galderma R&D
  More Information

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT02073448     History of Changes
Other Study ID Numbers: RDT.07.SPR.27123
Study First Received: February 20, 2014
Results First Received: September 15, 2016
Last Updated: February 27, 2017

Keywords provided by Galderma R&D:
Acne Vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
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

ClinicalTrials.gov processed this record on August 17, 2017