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Trial record 61 of 144 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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Intervention Drug: GK530G
Enrollment 436
Recruitment Details 436 subjects have been enrolled in 20 site in Japan: First subject included: May 16, 2013; last subject out: July 18, 2014
Pre-assignment Details  
Arm/Group Title GK530G
Hide Arm/Group Description the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Period Title: Overall Study
Started 436
Completed 391
Not Completed 45
Arm/Group Title GK530G
Hide Arm/Group Description the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Overall Number of Baseline Participants 436
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 436 participants
21.1  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 436 participants
Female
246
  56.4%
Male
190
  43.6%
1.Primary Outcome
Title Local Tolerability (Erythema)
Hide Description Highest severity of Local tolerability scores worth than base line
Time Frame 12 monhths
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GK530G
Hide Arm/Group Description:
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Overall Number of Participants Analyzed 436
Measure Type: Number
Unit of Measure: participants
Mild 149
Moderate 64
Severe 5
2.Primary Outcome
Title Local Tolerability (Scaling)
Hide Description Highest severity of Local tolerability scores worth than base line
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GK530G
Hide Arm/Group Description:
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Overall Number of Participants Analyzed 436
Measure Type: Number
Unit of Measure: participants
Mild 191
Moderate 60
Severe 2
3.Primary Outcome
Title Local Tolerability (Dryness)
Hide Description Highest Severity of Local Tolerability Scores Worse Than Baseline
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GK530G
Hide Arm/Group Description:
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Overall Number of Participants Analyzed 436
Measure Type: Number
Unit of Measure: participants
Mild 254
Moderate 52
Severe 1
4.Primary Outcome
Title Local Tolerability (Pruritus)
Hide Description Highest Severity of Local Tolerability Scores Worse Than Baseline
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GK530G
Hide Arm/Group Description:
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Overall Number of Participants Analyzed 436
Measure Type: Number
Unit of Measure: participants
Mild 149
Moderate 35
Severe 4
5.Primary Outcome
Title Local Tolerability (Stinging/Burning)
Hide Description Highest Severity of Local Tolerability Scores Worse Than Baseline
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GK530G
Hide Arm/Group Description:
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Overall Number of Participants Analyzed 436
Measure Type: Number
Unit of Measure: subjects
Mild 251
Moderate 79
Severe 9
6.Secondary Outcome
Title Percent Changes From Baseline in Total Lesion Counts
Hide Description [Not Specified]
Time Frame Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GK530G
Hide Arm/Group Description:
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
Overall Number of Participants Analyzed 436
Median (Full Range)
Unit of Measure: percent change
Week 1
25.6
(-52 to 88)
Week 2
42.1
(-87 to 93)
Week 4
52.9
(-74 to 98)
Month 2
67.1
(-65 to 100)
Month 3
74.7
(-1 to 100)
Month 6
82.0
(-81 to 100)
Month 9
83.6
(-40 to 100)
Month 12
86.2
(-16 to 100)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GK530G
Hide Arm/Group Description GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
All-Cause Mortality
GK530G
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GK530G
Affected / at Risk (%) # Events
Total   6/436 (1.38%)    
Gastrointestinal disorders   
Tooth impacted  1/436 (0.23%)  1
Infections and infestations   
Peritonitis  1/436 (0.23%)  1
Injury, poisoning and procedural complications   
Upper limb fracture  1/436 (0.23%)  1
Ligament rupture  1/436 (0.23%)  1
Ankle fracture  1/436 (0.23%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1/436 (0.23%)  1
Abortion  1/436 (0.23%)  1
Psychiatric disorders   
Panic disorder  1/436 (0.23%)  1
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
GK530G
Affected / at Risk (%) # Events
Total   311/436 (71.33%)    
Gastrointestinal disorders   
Dental caries  14/436 (3.21%)  15
Infections and infestations   
Nasopharyngitis  146/436 (33.49%)  199
Gastroenteritis  17/436 (3.90%)  18
Influenza  17/436 (3.90%)  17
Nervous system disorders   
Headache  18/436 (4.13%)  32
Reproductive system and breast disorders   
Dysmenorrhoea  18/436 (4.13%)  79
Skin and subcutaneous tissue disorders   
Skin irritation  65/436 (14.91%)  73
Pain of skin  29/436 (6.65%)  30
Eczema  15/436 (3.44%)  19
Heat rash  13/436 (2.98%)  14
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Project Manager
Organization: Galderma K.K.
Phone: +81 3 5937 3850
Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01910064     History of Changes
Other Study ID Numbers: RDT.07.SPR.27125
First Submitted: July 25, 2013
First Posted: July 29, 2013
Results First Submitted: September 15, 2016
Results First Posted: January 5, 2017
Last Update Posted: March 28, 2017