Acne VulgarisPhase 4NCT00671749
Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
A Phase 4 study testing adapalene gel, 0.3% and clindamycin/benzoyl peroxide gel in people with Acne Vulgaris, run by Galderma R&D at 4 sites in United States.
Trial summary
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- adapalene gel, 0.3% and clindamycin/benzoyl peroxide gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2007to Aug 2008
- Phase
- Phase 4
- 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
- Subjects with a minimum of 20 inflammatory lesions on the face;
- Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
- Subject has a Global Severity Assessment
Who cannot join
- 1. Subjects with more than three nodulo-cystic lesions
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Derm Research, P.L.L.C.
Louisville, Kentucky, 40217
Northwest Cutaneous Research Specialists
Portland, Oregon, 97210
Center for Dermatology and Laser Surgery
Sacramento, California, 95819
Brodell Medical
Warren, Ohio, 44483
About this study
Official title: A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
Read the detailed description
Same as above.
- Conditions
- Acne Vulgaris
- Being tested
- adapalene gel, 0.3%, clindamycin/benzoyl peroxide gel
- 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 gel, 0.3%Drug
Also called Differin® Gel, 0.3%
Applied once daily at bedtime
clindamycin/benzoyl peroxide gelDrug
Also called Duac® Gel
Applied once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment | Experimental | adapalene gel, 0.3%
Other Names:
Differin® Gel, 0.3% Applied once daily at bedtime
clindamycin/benzoyl peroxide gel
Other Names:
Duac® Gel Applied once daily in the morning Receives: Drug: adapalene gel, 0.3%; Drug: clindamycin/benzoyl peroxide gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Total Lesion Counts
Measured: 6 and 12 weeks
Secondary outcomes (6)
Global Severity Assessment Success
Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear
Measured: 6 and 12 weeks
Global Assessment of Improvement From Baseline
Measured: 12 weeks
Worst Post Baseline Tolerability Assessment - Erythema
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Measured: 12 weeks
Worst Post Baseline Tolerability Assessment - Scaling
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Measured: 12 weeks
Worst Post Baseline Tolerability Assessment - Dryness
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Measured: 12 weeks
Worst Post Baseline Tolerability Assessment - Burning/Stinging
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
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 posted5 May 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2008
- Study completionAug 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron W Gottschalk, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671749
- Sponsor's protocol ID
- US10066
- Status last verified
- Feb 2016
- First submitted
- 30 Apr 2008
- Last updated
- 23 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00671749
- Acronym / sponsor ID
- US10066
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Posted 16 Mar 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 determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
Detailed description
Same as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment | Experimental | Drug: adapalene gel, 0.3%, Drug: clindamycin/benzoyl peroxide geladapalene gel, 0.3% Other Names: Differin® Gel, 0.3% Applied once daily at bedtime clindamycin/benzoyl peroxide gel Other Names: Duac® Gel Applied once daily in the morning |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Subjects with a minimum of 20 inflammatory lesions on the face;
- Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
- Subject has a Global Severity Assessment
Key exclusion criteria (1 listed)
- 1. Subjects with more than three nodulo-cystic lesions
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 gel, 0.3%Also: Differin® Gel, 0.3%Applied once daily at bedtime | Drug | Study Treatment |
| clindamycin/benzoyl peroxide gelAlso: Duac® GelApplied once daily in the morning | Drug | Study Treatment |
Primary outcome
Percent Change From Baseline in Total Lesion Counts
Time frame: 6 and 12 weeks
6 secondary outcomes
Global Severity Assessment Success
Time frame: 6 and 12 weeks
Global Assessment of Improvement From Baseline
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Erythema
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Scaling
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Dryness
Time frame: 12 weeks
Worst Post Baseline Tolerability Assessment - Burning/Stinging
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 23 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ron W Gottschalk, MD study director
Galderma R&D
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adapalene gel, 0.3% and clindamycin/benzoyl peroxide gel in people with Acne Vulgaris, run by Galderma R&D at 4 sites in United States.
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 1 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 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 16 Mar 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 Change From Baseline in Total Lesion Counts (time frame: 6 and 12 weeks). 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 23 Aug 2022.