Acne VulgarisPhase 3NCT01910064

A Long Term Study of GK530G in Subjects With Acne Vulgaris

A Phase 3 study testing GK530G in people with Acne Vulgaris, run by Galderma R&D at 16 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: GK530G
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 436 participants
Where: 16 sitesJapan
Study dates: May 2013to Aug 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Japan16 sites

Galderma investigational site
Chiyoda City, Tokyo
Galderma investigational site
Fukuoka, Fukuoka
Galderma investigational site
Kawasaki, Kanagawa
Galderma investigational site
Koto, Tokyo
Galderma investigational site
Kōtō City, Tpkyo
Galderma investigational site
Kumagaya, Saitama
Galderma investigational site
Machida, Tokyo
Galderma investigational site
Musashino, Tokyo
Galderma investigational site
Ōta-ku, Tokyo
Galderma investigational site
Shibuya City, Tokyo
Galderma investigational site
Shinjuku, Tokyo
Galderma investigational site
Suginami, Tokyo
Galderma investigational site
Tachikawa, Tokyo
Galderma investigational site
Urayasu, Chiba
Galderma investigational site
Yamato, Kanagawa
Galderma investigational site
Yokohama, Kanagawa

Other trials in Japan

About this study

Conditions: Acne Vulgaris
Being tested: GK530G
Keywords: Acne Vulgaris
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GK530GDrug
Also called Fixed-dose combination gel of Adapalene and Benzoyl Peroxide

Study groups in NCT01910064
Study group	Role	What they receive
GK530G	Experimental	GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO Receives: Drug: GK530G

What is being measured

The primary outcome is the main question the study is designed to answer.

Local Tolerability (Erythema)
Highest severity of Local tolerability scores worth than base line
Measured: 12 monhths
Local Tolerability (Scaling)
Highest severity of Local tolerability scores worth than base line
Measured: 12 months
Local Tolerability (Dryness)
Highest Severity of Local Tolerability Scores Worse Than Baseline
Measured: 12 months
Local Tolerability (Pruritus)
Highest Severity of Local Tolerability Scores Worse Than Baseline
Measured: 12 months
Local Tolerability (Stinging/Burning)
Highest Severity of Local Tolerability Scores Worse Than Baseline
Measured: 12 months

Secondary outcomes (1)

Percent Changes From Baseline in Total Lesion Counts
Measured: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Aug 2014

First posted29 Jul 2013 (estimated)
Study startMay 2013
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 436 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01910064
Sponsor's protocol ID: RDT.07.SPR.27125
Status last verified: Feb 2017
First submitted: 25 Jul 2013
Last updated: 28 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long Term Study of GK530G in Subjects With Acne Vulgaris
ClinicalTrials.gov ID: NCT01910064
Acronym / sponsor ID: RDT.07.SPR.27125
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 436 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 29 Jul 2013 (estimated)
Results: Posted 5 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GK530G	Experimental	Drug: GK530GGK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GK530GAlso: Fixed-dose combination gel of Adapalene and Benzoyl Peroxide	Drug	GK530G

Primary outcome

Local Tolerability (Erythema)
Time frame: 12 monhths
Highest severity of Local tolerability scores worth than base line
Local Tolerability (Scaling)
Time frame: 12 months
Highest severity of Local tolerability scores worth than base line
Local Tolerability (Dryness)
Time frame: 12 months
Highest Severity of Local Tolerability Scores Worse Than Baseline
Local Tolerability (Pruritus)
Time frame: 12 months
Highest Severity of Local Tolerability Scores Worse Than Baseline
Local Tolerability (Stinging/Burning)
Time frame: 12 months
Highest Severity of Local Tolerability Scores Worse Than Baseline

1 secondary outcome

Percent Changes From Baseline in Total Lesion Counts
Time frame: Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12

Results and safety

Results posted to the registry on 5 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GK530G	436	391

Primary outcome: Local Tolerability (Erythema)

Time frame: 12 monhths. Number. Unit: participants

Measure	GK530G n = 436
Mild	149
Moderate	64
Severe	5

Primary outcome: Local Tolerability (Scaling)

Time frame: 12 months. Number. Unit: participants

Measure	GK530G n = 436
Mild	191
Moderate	60
Severe	2

Primary outcome: Local Tolerability (Dryness)

Time frame: 12 months. Number. Unit: participants

Measure	GK530G n = 436
Mild	254
Moderate	52
Severe	1

Primary outcome: Local Tolerability (Pruritus)

Time frame: 12 months. Number. Unit: participants

Measure	GK530G n = 436
Mild	149
Moderate	35
Severe	4

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GK530G	6 of 436 (1.4%)	311 of 436 (71.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GK530G in people with Acne Vulgaris, run by Galderma R&D at 16 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Tolerability (Erythema) (time frame: 12 monhths). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01910064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.