NCT02073448

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
417

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

13 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

First Submitted

Initial submission to the registry

February 20, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 3, 2016

Completed
Last Updated

March 28, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

February 20, 2014

Results QC Date

September 15, 2016

Last Update Submit

February 27, 2017

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Percent Changes From Baseline in Total Lesion Counts

    Baseline - Week12

Secondary Outcomes (6)

  • Percent of Subjects With Adverse Events

    up to 12 weeks

  • Local Tolerability (Erythema)

    12 weeks

  • Local Tolerability (Scaling)

    12 weeks

  • Local Tolerability (Dryness)

    12 weeks

  • Local Tolerability (Pruritus)

    12 weeks

  • +1 more secondary outcomes

Study Arms (3)

GK530G

EXPERIMENTAL

Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

Drug: GK530G

CD0271

ACTIVE COMPARATOR

Adapalene 01% Gel

Drug: CD0271

CD1579

ACTIVE COMPARATOR

Benzoyl Peroxide 2.5% Gel

Drug: CD1579

Interventions

GK530GDRUG
Also known as: Fixed-dose combination gel of Adapalene and Benzoyl Peroxide
GK530G
CD0271DRUG
Also known as: Adapalene 0.1% Gel
CD0271
CD1579DRUG
Also known as: Benzoyl Peroxide 2.5% Gel
CD1579

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 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Galderma investigational site

Chitose, Hokkaido, Japan

Location

Galderma investigational site

Kitami, Hokkaido, Japan

Location

Galderma investigational site

Sapporo, Hokkaido, Japan

Location

Galderma investigational site

Kagoshima, Kagoshima-ken, Japan

Location

Galderma investigational site

Yokohama, Kanagawa, Japan

Location

Galderma investigational site

Kurashiki, Okayama-ken, Japan

Location

Galderma investigational site

Daitō, Osaka, Japan

Location

Galderma investigational site

Neyagawa, Osaka, Japan

Location

Galderma investigational site

Osaka, Osaka, Japan

Location

Galderma investigational site

Sakai, Osaka, Japan

Location

Galderma investigational site

Saitama, Saitama, Japan

Location

Galderma investigational site

Adachi City, Tokyo, Japan

Location

Galderma investigational site

Setagaya City, Tokyo, Japan

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Benzoyl PeroxideAdapaleneGels

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2014

First Posted

February 27, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 28, 2017

Results First Posted

November 3, 2016

Record last verified: 2017-02

Locations

JP(13)