Acne VulgarisPhase 3NCT01138514
Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
A Phase 3 study testing Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) and Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) in people with Acne Vulgaris, run by Padagis LLC.
Trial summary
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel). Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) and Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,555 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Oct 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy men or women, 12 to 65 years of age
- Willing to participate and sign provide written consent
- Moderate to severe acne
Who cannot join
- Pregnant or lactating women
- History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin
- Use of systemic, topical or facial products which may interfere with the study
- Participation in any clinical study in the 30 days prior to study entry
- Prolonged exposure to sunlight or excessive exposure to UV lights
- Chronic use of NSAIDS
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo), Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin), Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)Drug
Applied to the entire face twice daily for 10 weeks
Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)Drug
Applied to the entire face twice daily for 10 weeks
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin 1%/Benzoyl Peroxide 5% | Active comparator | Not described Receives: Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) |
| Reference Product | Active comparator | Not described Receives: Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) |
| Vehicle | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Inflammatory Lesions
Measured: 10 weeks
Percent Change From Baseline in Non-inflammatory Lesions
Measured: 10 weeks
Secondary outcomes (1)
Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)
Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,555 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
- NCT01138514
- Sponsor's protocol ID
- PRG-716
- Status last verified
- Oct 2021
- First submitted
- 4 Jun 2010
- Last updated
- 13 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01138514
- Acronym / sponsor ID
- PRG-716
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,555 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Posted 29 Mar 2016
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 efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clindamycin 1%/Benzoyl Peroxide 5% | Active comparator | Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) |
| Reference Product | Active comparator | Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) |
| Vehicle | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men or women, 12 to 65 years of age
- Willing to participate and sign provide written consent
- Moderate to severe acne
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin
- Use of systemic, topical or facial products which may interfere with the study
- Participation in any clinical study in the 30 days prior to study entry
- Prolonged exposure to sunlight or excessive exposure to UV lights
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 |
|---|---|---|
| Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)Applied to the entire face twice daily for 10 weeks | Drug | Clindamycin 1%/Benzoyl Peroxide 5% |
| Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)Applied to the entire face twice daily for 10 weeks | Drug | Reference Product |
| PlaceboPlacebo | Drug | Vehicle |
Primary outcome
Percent Change From Baseline in Inflammatory Lesions
Time frame: 10 weeks
Percent Change From Baseline in Non-inflammatory Lesions
Time frame: 10 weeks
1 secondary outcome
Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- 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 Phase 3 study testing Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) and Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) 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 13 Oct 2021. 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.
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 29 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 Inflammatory Lesions (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 13 Oct 2021.