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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.

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
GK530G
CD0271
CD1579
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site
  • Galderma investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

GK530G

CD0271

CD1579

Arm Description

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

Adapalene 01% Gel

Benzoyl Peroxide 2.5% Gel

Outcomes

Primary Outcome Measures

Percent Changes From Baseline in Total Lesion Counts

Secondary Outcome Measures

Percent of Subjects With Adverse Events
Local Tolerability (Erythema)
Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Scaling)
Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Dryness)
Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Pruritus)
Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Stinging/Burning)
Highest severity of local tolerability scores worse than Baseline

Full Information

First Posted
February 20, 2014
Last Updated
February 27, 2017
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02073448
Brief Title
Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
417 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GK530G
Arm Type
Experimental
Arm Description
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Arm Title
CD0271
Arm Type
Active Comparator
Arm Description
Adapalene 01% Gel
Arm Title
CD1579
Arm Type
Active Comparator
Arm Description
Benzoyl Peroxide 2.5% Gel
Intervention Type
Drug
Intervention Name(s)
GK530G
Other Intervention Name(s)
Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Intervention Type
Drug
Intervention Name(s)
CD0271
Other Intervention Name(s)
Adapalene 0.1% Gel
Intervention Type
Drug
Intervention Name(s)
CD1579
Other Intervention Name(s)
Benzoyl Peroxide 2.5% Gel
Primary Outcome Measure Information:
Title
Percent Changes From Baseline in Total Lesion Counts
Time Frame
Baseline - Week12
Secondary Outcome Measure Information:
Title
Percent of Subjects With Adverse Events
Time Frame
up to 12 weeks
Title
Local Tolerability (Erythema)
Description
Highest severity of local tolerability scores worse than Baseline
Time Frame
12 weeks
Title
Local Tolerability (Scaling)
Description
Highest severity of local tolerability scores worse than Baseline
Time Frame
12 weeks
Title
Local Tolerability (Dryness)
Description
Highest severity of local tolerability scores worse than Baseline
Time Frame
12 weeks
Title
Local Tolerability (Pruritus)
Description
Highest severity of local tolerability scores worse than Baseline
Time Frame
12 weeks
Title
Local Tolerability (Stinging/Burning)
Description
Highest severity of local tolerability scores worse than Baseline
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Galderma investigational site
City
Chitose
State/Province
Hokkaido
Country
Japan
Facility Name
Galderma investigational site
City
Kitami
State/Province
Hokkaido
Country
Japan
Facility Name
Galderma investigational site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Galderma investigational site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Galderma investigational site
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Galderma investigational site
City
Daito
State/Province
Osaka
Country
Japan
Facility Name
Galderma investigational site
City
Neyagawa
State/Province
Osaka
Country
Japan
Facility Name
Galderma investigational site
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Galderma investigational site
City
Adachi
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
Galderma investigational site
City
Kagoshima
Country
Japan
Facility Name
Galderma investigational site
City
Osaka
Country
Japan
Facility Name
Galderma investigational site
City
Saitama
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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