NCT01910064

Brief Summary

This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
436

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 5, 2017

Completed
Last Updated

March 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

July 25, 2013

Results QC Date

September 15, 2016

Last Update Submit

February 27, 2017

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris

Outcome Measures

Primary Outcomes (5)

  • Local Tolerability (Erythema)

    Highest severity of Local tolerability scores worth than base line

    12 monhths

  • Local Tolerability (Scaling)

    Highest severity of Local tolerability scores worth than base line

    12 months

  • Local Tolerability (Dryness)

    Highest Severity of Local Tolerability Scores Worse Than Baseline

    12 months

  • Local Tolerability (Pruritus)

    Highest Severity of Local Tolerability Scores Worse Than Baseline

    12 months

  • Local Tolerability (Stinging/Burning)

    Highest Severity of Local Tolerability Scores Worse Than Baseline

    12 months

Secondary Outcomes (1)

  • Percent Changes From Baseline in Total Lesion Counts

    Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12

Study Arms (1)

GK530G

EXPERIMENTAL

GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO

Drug: GK530G

Interventions

GK530GDRUG
Also known as: Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 non-inflammatory 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).

You may not qualify if:

  • Those with more than two nodular acne lesions or any cyst.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Galderma investigational site

Urayasu, Chiba, Japan

Location

Galderma investigational site

Fukuoka, Fukuoka, Japan

Location

Galderma investigational site

Kawasaki, Kanagawa, Japan

Location

Galderma investigational site

Yamato, Kanagawa, Japan

Location

Galderma investigational site

Yokohama, Kanagawa, Japan

Location

Galderma investigational site

Kumagaya, Saitama, Japan

Location

Galderma investigational site

Chiyoda City, Tokyo, Japan

Location

Galderma investigational site

Koto, Tokyo, Japan

Location

Galderma investigational site

Machida, Tokyo, Japan

Location

Galderma investigational site

Musashino, Tokyo, Japan

Location

Galderma investigational site

Ōta-ku, Tokyo, Japan

Location

Galderma investigational site

Shibuya City, Tokyo, Japan

Location

Galderma investigational site

Shinjuku, Tokyo, Japan

Location

Galderma investigational site

Suginami, Tokyo, Japan

Location

Galderma investigational site

Tachikawa, Tokyo, Japan

Location

Galderma investigational site

Kōtō City, Tpkyo, Japan

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Benzoyl Peroxide

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Clinical Project Manager
Organization
Galderma K.K.
GaldermaKK.ClinDev@galderma.com
+81 3 5937 3850

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2013

First Posted

July 29, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 28, 2017

Results First Posted

January 5, 2017

Record last verified: 2017-02

Locations

JP(16)