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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02073448

Enrollment

417

Registered

2014-02-27

Start date

2014-03-31

Completion date

2014-10-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris

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.

Interventions

DRUGGK530G

DRUGCD0271

DRUGCD1579

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Percent Changes From Baseline in Total Lesion Counts	Baseline - Week12

Secondary

Measure	Time frame	Description
Local Tolerability (Dryness)	12 weeks	Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Pruritus)	12 weeks	Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Scaling)	12 weeks	Highest severity of local tolerability scores worse than Baseline
Percent of Subjects With Adverse Events	up to 12 weeks	—
Local Tolerability (Stinging/Burning)	12 weeks	Highest severity of local tolerability scores worse than Baseline
Local Tolerability (Erythema)	12 weeks	Highest severity of local tolerability scores worse than Baseline

Countries

Japan

Participant flow

Participants by arm

Arm	Count
GK530G Fixed-dose combination gel of Adapalene and Benzoyl Peroxide GK530G	212
CD0271 Adapalene 01% Gel CD0271	101
CD1579 Benzoyl Peroxide 2.5% Gel CD1579	104
Total	417

Baseline characteristics

Characteristic	CD0271	CD1579	GK530G	Total
Age, Categorical <=18 years	56 Participants	56 Participants	116 Participants	228 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	45 Participants	48 Participants	96 Participants	189 Participants
Age, Continuous	19.6 years STANDARD_DEVIATION 6	19.3 years STANDARD_DEVIATION 5.4	19.7 years STANDARD_DEVIATION 6.5	19.6 years STANDARD_DEVIATION 6.1
Region of Enrollment Japan	101 participants	104 participants	212 participants	417 participants
Sex: Female, Male Female	67 Participants	74 Participants	141 Participants	282 Participants
Sex: Female, Male Male	34 Participants	30 Participants	71 Participants	135 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	28 / 101	95 / 212	39 / 104
serious Total, serious adverse events	0 / 101	0 / 212	0 / 104

Outcome results

Primary

Percent Changes From Baseline in Total Lesion Counts

Time frame: Baseline - Week12

Arm	Measure	Value (MEDIAN)
CD0271	Percent Changes From Baseline in Total Lesion Counts	68.6 percent change
GK530G	Percent Changes From Baseline in Total Lesion Counts	82.7 percent change
CD1579	Percent Changes From Baseline in Total Lesion Counts	81.6 percent change

Secondary