AcnePhase 3FREENCT00883233
Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
A Phase 3 study testing Adapalene BPO Gel standard daily overnight application, Adapalene-BPO 3-hour daily application before bedtime and Adapalene-BPO Gel every other day application in people with Acne, run by Galderma R&D at 2 sites in Canada.
Trial summary
The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Acne
- What is being tested?
- Adapalene BPO Gel standard daily overnight application, Adapalene-BPO 3-hour daily application before bedtime and Adapalene-BPO Gel every other day application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2009to Sep 2009
- 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 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female Subjects of any race, aged 12 to 35 years inclusive
- Subjects with mild or moderate facial acne vulgaris
- Subjects with skin phototype I to IV
Who cannot join
- Subjects with more than 1 nodules or cysts on the face,
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Galderma Investigational Site
Montreal, Quebec
Galderma Investigational Site
Windsor, Ontario
About this study
Official title: Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.
- Conditions
- Acne
- Being tested
- Adapalene BPO Gel standard daily overnight application, Adapalene-BPO 3-hour daily application before bedtime, Adapalene-BPO Gel every other day application, Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
- Keywords
- Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapalene BPO Gel standard daily overnight applicationDrug
Also called Standard
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
Adapalene-BPO 3-hour daily application before bedtimeDrug
Also called 3-hour before bedtime
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
Adapalene-BPO Gel every other day applicationDrug
Also called every other day
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
Adapalene-BPO Gel standard+Cetaphil® Moisturizing LotionDrug
Also called Adapalene-BPO Gel with Cetaphil® Moisturizing Lotion
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks Receives: Drug: Adapalene-BPO 3-hour daily application before bedtime |
| 2 | Experimental | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks Receives: Drug: Adapalene-BPO Gel every other day application |
| 3 | Experimental | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks Receives: Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion |
| 4 | Active comparator | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week Receives: Drug: Adapalene BPO Gel standard daily overnight application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.
Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2009
- Study completionSep 2009
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 AcneStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jerry Tan, MD, Principal investigator, Windsor, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883233
- Sponsor's protocol ID
- RD.03.SPR.29085
- Acronym
- FREE
- Status last verified
- Nov 2010
- First submitted
- 16 Apr 2009
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00883233
- Acronym / sponsor ID
- FREE / RD.03.SPR.29085
- Conditions
- Acne
- Keywords
- Acne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Posted 8 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Adapalene-BPO 3-hour daily application before bedtimeAdapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks |
| 2 | Experimental | Drug: Adapalene-BPO Gel every other day applicationAdapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks |
| 3 | Experimental | Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing LotionAdapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks |
| 4 | Active comparator | Drug: Adapalene BPO Gel standard daily overnight applicationAdapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female Subjects of any race, aged 12 to 35 years inclusive
- Subjects with mild or moderate facial acne vulgaris
- Subjects with skin phototype I to IV
Key exclusion criteria (2 listed)
- Subjects with more than 1 nodules or cysts on the face,
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
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 |
|---|---|---|
| Adapalene BPO Gel standard daily overnight applicationAlso: StandardAdapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week | Drug | 4 |
| Adapalene-BPO 3-hour daily application before bedtimeAlso: 3-hour before bedtimeAdapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks | Drug | 1 |
| Adapalene-BPO Gel every other day applicationAlso: every other dayAdapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks | Drug | 2 |
| Adapalene-BPO Gel standard+Cetaphil® Moisturizing LotionAlso: Adapalene-BPO Gel with Cetaphil® Moisturizing LotionAdapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks | Drug | 3 |
Primary outcome
Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.
Time frame: Week 4
Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Acne
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.
Acne, Acne Papulopustulosa
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)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Jerry Tan, MD principal investigator
Windsor, ON, Canada
2 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 Adapalene BPO Gel standard daily overnight application, Adapalene-BPO 3-hour daily application before bedtime and Adapalene-BPO Gel every other day application in people with Acne, run by Galderma R&D at 2 sites in Canada.
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 3 inclusion and 2 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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. 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 8 Dec 2010). 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 Was Analyzed in Terms of Worst Score Post-Baseline. (time frame: Week 4). 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 18 Feb 2021.