Acne VulgarisPhase 3NCT01880320

Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

A Phase 3 study testing CD0271 0.3% / CD1579 2.5% and CD0271 0.1% / CD1579 2.5% in people with Acne Vulgaris, run by Galderma R&D at 31 sites in 2 countries.

Completed

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

Official record

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Trial summary

The study hypothesis are based on the assumption that : CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and… 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?: CD0271 0.3% / CD1579 2.5% and CD0271 0.1% / CD1579 2.5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 503 participants
Where: 31 sitesin 2 countries
Study dates: Jul 2013to Mar 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

Male or female, who is 12 years of age or older at Screening visit.
Clinical diagnosis of acne vulgaris with facial involvement.
An IGA of Moderate (3) or Severe (4) at Baseline visit.
A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.

Who cannot join

More than 2 acne nodules on the face at Baseline visit.
Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
Use of hormonal contraceptives solely for control of acne.

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States25 sites

Galderma Investigational Site
Albuquerque, New Mexico
Galderma Investigational Site
Arlington, Texas
Galderma Investigational Site
Beachwood, Ohio
Galderma Investigational site
Birmingham, Alabama
Galderma Investigational Site
Chicago, Illinois
Galderma Investigational Site
Detroit, Michigan
Galderma Investigational Site
Goodlettsville, Tennessee
Galderma Investigational Site
Greenville, South Carolina
Galderma investigational Site
Hershey, Pennsylvania
Galderma investigational Site
Hot Springs, Arkansas
Galderma Investigational Site
Knoxville, Tennessee
Galderma Investigational Site
Los Angeles, California
Galderma Investigational Site
Miami, Florida
Galderma Investigational Site
Miramar, Florida
Galderma Investigationnal Site
Mobile, Alabama
Galderma Investigational Site
New York, New York
Galderma Investiogational Site
Newnan, Georgia
Galderma Investigational Site
Raleigh, North Carolina
Galderma Investigational Site
Sacramento, California
Galderma Investigational Site
Salt Lake City, Utah
Galderma Investigational Site
San Antonio, Texas
Galderma Investigational Site
Santa Monica, California
Galderma Investigational Site
Snellville, Georgia
Galderma Investigational Site
Spokane, Washington
Galderma Investigational Site
Stony Brook, New York

Other trials in United States

Canada6 sites

Galderma Investigational Site
Barrie
Galderma Investigational Site
Markham
Galderma Investiogational Site
Montreal
Galderma Investigational Site
Peterborough
Galderma Investigational site
Surrey
Galderma Investigational Site
Waterloo

Other trials in Canada

About this study

Official title: A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris

The study hypothesis are based on the assumption that :

CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects
CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile

Conditions: Acne Vulgaris
Being tested: CD0271 0.3% / CD1579 2.5%, CD0271 0.1% / CD1579 2.5%, Topical Gel Vehicle
Medical subject headings: Acne Vulgaris

What participants receive

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

CD0271 0.3% / CD1579 2.5%Drug
CD0271 0.1% / CD1579 2.5%Drug
Topical Gel VehicleDrug

Study groups in NCT01880320
Study group	Role	What they receive
CD0271 0.3% /CD1579 2.5% Gel	Experimental	active arm Receives: Drug: CD0271 0.3% / CD1579 2.5%
CD0271 0.1% / CD1579 2.5%	Active comparator	Comparator arm Receives: Drug: CD0271 0.1% / CD1579 2.5%
Topical Gel Vehicle	Placebo comparator	Placebo arm Receives: Drug: Topical Gel Vehicle

What is being measured

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

Success Rate
Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA).
Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Measured: Week 12
Changes From Baseline in Inflammatory Lesion Counts
Measured: Baseline - Week12
Changes From Baseline in Non-Inflammatory Lesion Counts
Measured: Baseline - Week 12

Timeline

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

Jul 2013Mar 2014

First posted18 Jun 2013 (estimated)
Study startJul 2013
Primary completionMar 2014
Study completionMar 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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
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: 503 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01880320
Sponsor's protocol ID: RD.06.SPR.18240
Status last verified: May 2018
First submitted: 14 Jun 2013
Last updated: 28 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Stein Gold L, Werschler WP, Mohawk J. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender. J Drugs Dermatol. 2017 Jun 1;16(6):582-589.
PubMed 28686776
Alexis AF, Cook-Bolden FE, York JP. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes. J Drugs Dermatol. 2017 Jun 1;16(6):574-581.
PubMed 28686775
Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.
PubMed 26945741

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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Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris
ClinicalTrials.gov ID: NCT01880320
Acronym / sponsor ID: RD.06.SPR.18240
Conditions: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 503 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 18 Jun 2013 (estimated)
Results: Posted 9 Sep 2016

Clinical summary

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

The study hypothesis are based on the assumption that :

CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects
CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
CD0271 0.3% /CD1579 2.5% Gel	Experimental	Drug: CD0271 0.3% / CD1579 2.5%active arm
CD0271 0.1% / CD1579 2.5%	Active comparator	Drug: CD0271 0.1% / CD1579 2.5%Comparator arm
Topical Gel Vehicle	Placebo comparator	Drug: Topical Gel VehiclePlacebo arm

Who may qualify

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

Key inclusion criteria (5 listed)

Male or female, who is 12 years of age or older at Screening visit.
Clinical diagnosis of acne vulgaris with facial involvement.
An IGA of Moderate (3) or Severe (4) at Baseline visit.
A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.

Key exclusion criteria (6 listed)

More than 2 acne nodules on the face at Baseline visit.
Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
The subject is unwilling to refrain from use of prohibited medication during the clinical trial.

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
CD0271 0.3% / CD1579 2.5%	Drug	CD0271 0.3% /CD1579 2.5% Gel
CD0271 0.1% / CD1579 2.5%	Drug	CD0271 0.1% / CD1579 2.5%
Topical Gel Vehicle	Drug	Topical Gel Vehicle

Primary outcome

Success Rate
Time frame: Week 12
Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Changes From Baseline in Inflammatory Lesion Counts
Time frame: Baseline - Week12
Changes From Baseline in Non-Inflammatory Lesion Counts
Time frame: Baseline - Week 12

Results and safety

Results posted to the registry on 9 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CD0271 0.3% /CD1579 2.5% Gel	217	197
CD0271 0.1% / CD1579 2.5%	217	192
Topical Gel Vehicle	69	61

Primary outcome: Success Rate

Time frame: Week 12. Number. Unit: percentage of participants

Measure	CD0271 0.3% /CD1579 2.5% Gel n = 217	CD0271 0.1% / CD1579 2.5% n = 217	Topical Gel Vehicle n = 69
All subjects (MI: Multiple Imputation)	33.7	27.3	11.0
Baseline IGA=Severe (4) (MI: Multiple Imputation)	31.9	20.5	11.8

Population analysed: Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.

Primary outcome: Changes From Baseline in Inflammatory Lesion Counts

Time frame: Baseline - Week12. Least squares mean (Standard Error). Unit: Lesions

Measure	CD0271 0.3% /CD1579 2.5% Gel n = 217	CD0271 0.1% / CD1579 2.5% n = 217	Topical Gel Vehicle n = 69
All Subjects	-27.04 (0.846)	-26.72 (0.822)	-14.40 (1.460)
Baseline IGA = Severe (4)	-35.17 (1.407)	-31.92 (1.320)	-15.46 (2.297)

Population analysed: ITT Population, Multiple imputation

Primary outcome: Changes From Baseline in Non-Inflammatory Lesion Counts

Time frame: Baseline - Week 12. Least squares mean (Standard Error). Unit: lesions

Measure	CD0271 0.3% /CD1579 2.5% Gel n = 217	CD0271 0.1% / CD1579 2.5% n = 217	Topical Gel Vehicle n = 69
All Subjects	-40.18 (1.332)	-39.00 (1.277)	-18.47 (2.270)
Baseline IGA = Severe (4)	-45.61 (2.058)	-43.10 (1.847)	-17.25 (3.337)

Population analysed: ITT Population, Multiple Imputation

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CD0271 0.3% /CD1579 2.5% Gel	0 of 217 (0%)	34 of 217 (15.7%)	Not reported
CD0271 0.1% / CD1579 2.5%	1 of 217 (0.5%)	23 of 217 (10.6%)	Not reported
Topical Gel Vehicle	0 of 69 (0%)	13 of 69 (18.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28686776Stein Gold L, Werschler WP, Mohawk J. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender. J Drugs Dermatol. 2017 Jun 1;16(6):582-589.
Derived from this study: PubMed 28686775Alexis AF, Cook-Bolden FE, York JP. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes. J Drugs Dermatol. 2017 Jun 1;16(6):574-581.
Derived from this study: PubMed 26945741Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4.

Related trials for Acne Vulgaris

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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.

31 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CD0271 0.3% / CD1579 2.5% and CD0271 0.1% / CD1579 2.5% in people with Acne Vulgaris, run by Galderma R&D at 31 sites in 2 countries.

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 5 inclusion and 6 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 9 Sep 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?

Success Rate (time frame: Week 12). The study lists 3 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 NCT01880320, which also lists 3 linked publications.

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 Jun 2018.