Acne VulgarisNCT01044264
Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations
A study testing 1% Clindamycin/5% Benzoyl Peroxide Topical Gel in people with Acne Vulgaris, run by Padagis LLC.
Trial summary
A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 602 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Sep 2008
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy men or women, 12 years of age and older
- willing to participate and sign a copy of the informed consent form
- moderate to severe facial acne
Who cannot join
- history of allergy or hypersensitivity to clindamycin or benzoyl peroxide
- pregnant or lactating women
- evidence of a clinically significant disorder
- receipt of any drugs as part of a research study within 30 days prior to study dosing
- use of systemic, topical or facial products which may interfere with study
- significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn
About this study
Official title: A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations in the Treatment of Moderate to Severe Acne Vulgaris
A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.
- Conditions
- Acne Vulgaris
- Being tested
- 1% Clindamycin/5% Benzoyl Peroxide Topical Gel, Placebo
- Keywords
- Acne Vulgaris, bioequivalency, clindamycin, benzoyl peroxide
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Clindamycin/5% Benzoyl Peroxide Topical GelDrug
Also called DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Topical Gel
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Active comparator | Test product Receives: Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel |
| DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Active comparator | Reference product Receives: Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Inflammatory Lesions
The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
Measured: Baseline and week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionSep 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044264
- Sponsor's protocol ID
- DAC-501-601-727998
- Status last verified
- Jul 2023
- First submitted
- 4 Jan 2010
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations in the Treatment of Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01044264
- Acronym / sponsor ID
- DAC-501-601-727998
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, bioequivalency, clindamycin, benzoyl peroxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Posted 17 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Active comparator | Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical GelTest product |
| DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Active comparator | Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical GelReference product |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- healthy men or women, 12 years of age and older
- willing to participate and sign a copy of the informed consent form
- moderate to severe facial acne
Key exclusion criteria (6 listed)
- history of allergy or hypersensitivity to clindamycin or benzoyl peroxide
- pregnant or lactating women
- evidence of a clinically significant disorder
- receipt of any drugs as part of a research study within 30 days prior to study dosing
- use of systemic, topical or facial products which may interfere with study
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 |
|---|---|---|
| 1% Clindamycin/5% Benzoyl Peroxide Topical GelAlso: DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical GelTopical Gel | Drug | 1% Clindamycin/5% Benzoyl Peroxide Topical Gel, DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Reduction of Inflammatory Lesions
Time frame: Baseline and week 11
The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing 1% Clindamycin/5% Benzoyl Peroxide Topical Gel in people with Acne Vulgaris, run by Padagis LLC.
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 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 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2012). 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?
Reduction of Inflammatory Lesions (time frame: Baseline and week 11). 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 12 Jul 2023.