Acne VulgarisPhase 3NCT02073448
Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.
A Phase 3 study testing GK530G, CD0271 and CD1579 in people with Acne Vulgaris, run by Galderma R&D at 13 sites in Japan.
Trial 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. 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, CD0271 and CD1579
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 13 sitesJapan
- Study dates
- Mar 2014to Oct 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 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).
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Galderma investigational site
Adachi City, Tokyo
Galderma investigational site
Chitose, Hokkaido
Galderma investigational site
Daitō, Osaka
Galderma investigational site
Kagoshima, Kagoshima-ken
Galderma investigational site
Kitami, Hokkaido
Galderma investigational site
Kurashiki, Okayama-ken
Galderma investigational site
Neyagawa, Osaka
Galderma investigational site
Osaka, Osaka
Galderma investigational site
Saitama, Saitama
Galderma investigational site
Sakai, Osaka
Galderma investigational site
Sapporo, Hokkaido
Galderma investigational site
Setagaya City, Tokyo
Galderma investigational site
Yokohama, Kanagawa
About this study
Official title: 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.
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.
- Conditions
- Acne Vulgaris
- Being tested
- GK530G, CD0271, CD1579
- 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
CD0271Drug
Also called Adapalene 0.1% Gel
CD1579Drug
Also called Benzoyl Peroxide 2.5% Gel
| Study group | Role | What they receive |
|---|---|---|
| GK530G | Experimental | Fixed-dose combination gel of Adapalene and Benzoyl Peroxide Receives: Drug: GK530G |
| CD0271 | Active comparator | Adapalene 01% Gel Receives: Drug: CD0271 |
| CD1579 | Active comparator | Benzoyl Peroxide 2.5% Gel Receives: Drug: CD1579 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Changes From Baseline in Total Lesion Counts
Measured: Baseline - Week12
Secondary outcomes (6)
Percent of Subjects With Adverse Events
Measured: up to 12 weeks
Local Tolerability (Erythema)
Highest severity of local tolerability scores worse than Baseline
Measured: 12 weeks
Local Tolerability (Scaling)
Highest severity of local tolerability scores worse than Baseline
Measured: 12 weeks
Local Tolerability (Dryness)
Highest severity of local tolerability scores worse than Baseline
Measured: 12 weeks
Local Tolerability (Pruritus)
Highest severity of local tolerability scores worse than Baseline
Measured: 12 weeks
Local Tolerability (Stinging/Burning)
Highest severity of local tolerability scores worse than Baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073448
- Sponsor's protocol ID
- RDT.07.SPR.27123
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2014
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 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.
- ClinicalTrials.gov ID
- NCT02073448
- Acronym / sponsor ID
- RDT.07.SPR.27123
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Posted 3 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GK530G | Experimental | Drug: GK530GFixed-dose combination gel of Adapalene and Benzoyl Peroxide |
| CD0271 | Active comparator | Drug: CD0271Adapalene 01% Gel |
| CD1579 | Active comparator | Drug: CD1579Benzoyl Peroxide 2.5% Gel |
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 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).
Key exclusion criteria (3 listed)
- 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.
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 |
| CD0271Also: Adapalene 0.1% Gel | Drug | CD0271 |
| CD1579Also: Benzoyl Peroxide 2.5% Gel | Drug | CD1579 |
Primary outcome
Percent Changes From Baseline in Total Lesion Counts
Time frame: Baseline - Week12
6 secondary outcomes
Percent of Subjects With Adverse Events
Time frame: up to 12 weeks
Local Tolerability (Erythema)
Time frame: 12 weeks
Local Tolerability (Scaling)
Time frame: 12 weeks
Local Tolerability (Dryness)
Time frame: 12 weeks
Local Tolerability (Pruritus)
Time frame: 12 weeks
Local Tolerability (Stinging/Burning)
Time frame: 12 weeks
Results and safety
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.
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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.
13 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, CD0271 and CD1579 in people with Acne Vulgaris, run by Galderma R&D at 13 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 13 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 3 Nov 2016). 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?
Percent Changes From Baseline in Total Lesion Counts (time frame: Baseline - Week12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.