Trial Outcomes & Findings for A Long Term Study of GK530G in Subjects With Acne Vulgaris (NCT NCT01910064)
NCT ID: NCT01910064
Last Updated: 2017-03-28
Results Overview
Highest severity of Local tolerability scores worth than base line
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
436 participants
Primary outcome timeframe
12 monhths
Results posted on
2017-03-28
Participant Flow
436 subjects have been enrolled in 20 site in Japan: First subject included: May 16, 2013; last subject out: July 18, 2014
Participant milestones
| Measure |
GK530G
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
|
|---|---|
|
Overall Study
STARTED
|
436
|
|
Overall Study
COMPLETED
|
391
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Long Term Study of GK530G in Subjects With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
GK530G
n=436 Participants
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
|
|---|---|
|
Age, Continuous
|
21.1 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
246 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
190 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monhthsHighest severity of Local tolerability scores worth than base line
Outcome measures
| Measure |
GK530G
n=436 Participants
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
|
|---|---|
|
Local Tolerability (Erythema)
Mild
|
149 participants
|
|
Local Tolerability (Erythema)
Moderate
|
64 participants
|
|
Local Tolerability (Erythema)
Severe
|
5 participants
|
PRIMARY outcome
Timeframe: 12 monthsHighest severity of Local tolerability scores worth than base line
Outcome measures
| Measure |
GK530G
n=436 Participants
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
|
|---|---|
|
Local Tolerability (Scaling)
Mild
|
191 participants
|
|
Local Tolerability (Scaling)
Moderate
|
60 participants
|
|
Local Tolerability (Scaling)
Severe
|
2 participants
|
PRIMARY outcome
Timeframe: 12 monthsHighest Severity of Local Tolerability Scores Worse Than Baseline
Outcome measures
| Measure |
GK530G
n=436 Participants
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
|
|---|---|
|
Local Tolerability (Dryness)
Mild
|
254 participants
|
|
Local Tolerability (Dryness)
Moderate
|
52 participants
|
|
Local Tolerability (Dryness)
Severe
|
1 participants
|
PRIMARY outcome
Timeframe: 12 monthsHighest Severity of Local Tolerability Scores Worse Than Baseline
Outcome measures
| Measure |
GK530G
n=436 Participants
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
|
|---|---|
|
Local Tolerability (Pruritus)
Mild
|
149 participants
|
|
Local Tolerability (Pruritus)
Moderate
|
35 participants
|
|
Local Tolerability (Pruritus)
Severe
|
4 participants
|
PRIMARY outcome
Timeframe: 12 monthsHighest Severity of Local Tolerability Scores Worse Than Baseline
Outcome measures
| Measure |
GK530G
n=436 Participants
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
|
|---|---|
|
Local Tolerability (Stinging/Burning)
Mild
|
251 subjects
|
|
Local Tolerability (Stinging/Burning)
Moderate
|
79 subjects
|
|
Local Tolerability (Stinging/Burning)
Severe
|
9 subjects
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12Outcome measures
| Measure |
GK530G
n=436 Participants
the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
|
|---|---|
|
Percent Changes From Baseline in Total Lesion Counts
Week 1
|
25.6 percent change
Interval -52.0 to 88.0
|
|
Percent Changes From Baseline in Total Lesion Counts
Week 2
|
42.1 percent change
Interval -87.0 to 93.0
|
|
Percent Changes From Baseline in Total Lesion Counts
Week 4
|
52.9 percent change
Interval -74.0 to 98.0
|
|
Percent Changes From Baseline in Total Lesion Counts
Month 2
|
67.1 percent change
Interval -65.0 to 100.0
|
|
Percent Changes From Baseline in Total Lesion Counts
Month 3
|
74.7 percent change
Interval -1.0 to 100.0
|
|
Percent Changes From Baseline in Total Lesion Counts
Month 6
|
82.0 percent change
Interval -81.0 to 100.0
|
|
Percent Changes From Baseline in Total Lesion Counts
Month 9
|
83.6 percent change
Interval -40.0 to 100.0
|
|
Percent Changes From Baseline in Total Lesion Counts
Month 12
|
86.2 percent change
Interval -16.0 to 100.0
|
Adverse Events
GK530G
Serious events: 6 serious events
Other events: 311 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GK530G
n=436 participants at risk
GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
|
|---|---|
|
Infections and infestations
Peritonitis
|
0.23%
1/436 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Tooth impacted
|
0.23%
1/436 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Panic disorder
|
0.23%
1/436 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.23%
1/436 • Number of events 1 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.23%
1/436 • Number of events 1 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.23%
1/436 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.23%
1/436 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.23%
1/436 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
GK530G
n=436 participants at risk
GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
33.5%
146/436 • Number of events 199 • 12 months
|
|
Infections and infestations
Gastroenteritis
|
3.9%
17/436 • Number of events 18 • 12 months
|
|
Infections and infestations
Influenza
|
3.9%
17/436 • Number of events 17 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
14.9%
65/436 • Number of events 73 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.7%
29/436 • Number of events 30 • 12 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.4%
15/436 • Number of events 19 • 12 months
|
|
Gastrointestinal disorders
Dental caries
|
3.2%
14/436 • Number of events 15 • 12 months
|
|
Nervous system disorders
Headache
|
4.1%
18/436 • Number of events 32 • 12 months
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
3.0%
13/436 • Number of events 14 • 12 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.1%
18/436 • Number of events 79 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place