Acne VulgarisPhase 3NCT02465632
To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.
A Phase 3 study testing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% in people with Acne Vulgaris, run by Glenmark Pharmaceuticals Ltd. India at 15 sites in 2 countries.
Trial summary
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant… Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Apr 2015to Dec 2015
- 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
- Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.
Who cannot join
- Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
- Subject has active cystic acne.
- Subject has acne conglobata.
- Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States13 sites
Glenmark Investigational Site 13
Anaheim, California
Glenmark Investigational Site 4
Brandon, Florida
Glenmark Investigational Site 14
Greenville, South Carolina
Glenmark Investigational Site 6
Long Beach, California
Glenmark Investigational Site 15
Los Angeles, California
Glenmark Investigational Site 5
Louisville, Kentucky
Glenmark Investigational Site 1
Miami, Florida
Glenmark Investigational Site 8
Miami, Florida
Glenmark Investigational Site 9
Miramar, Florida
Glenmark Investigational Site 3
Nashville, Tennessee
Glenmark Investigational Site 2
St. Petersburg, Florida
Glenmark Investigational Site7
Upper Saint Clair, Pennsylvania
Glenmark Investigational Site12
West Covina, California
Belize2 sites
Glenmark Investigational Site 10
Belize City
Glenmark Investigational Site 11
Belize City
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Valeant Pharmaceuticals, US) in the Treatment of Acne Vulgaris.
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel, BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%, 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% Topical GelDrug
BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel | Experimental | apply a thin layer of gel to the face Receives: Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel |
| BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% | Active comparator | apply a thin layer of the gel to the face Receives: Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% |
| Placebo topical gel | Placebo comparator | apply a thin layer of the gel to the face Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.
Measured: Baseline and 10 Weeks
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.
Measured: Baseline and 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionDec 2015
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahesh V Deshpande, Study director, Glenmark Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465632
- Sponsor's protocol ID
- GLK-1403
- Status last verified
- Dec 2015
- First submitted
- 4 Jun 2015
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Valeant Pharmaceuticals, US) in the Treatment of Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT02465632
- Acronym / sponsor ID
- GLK-1403
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.
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 |
|---|---|---|
| Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel | Experimental | Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gelapply a thin layer of gel to the face |
| BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% | Active comparator | Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%apply a thin layer of the gel to the face |
| Placebo topical gel | Placebo comparator | Drug: Placeboapply a thin layer of the gel to the face |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
- Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.
Key exclusion criteria (4 listed)
- Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
- Subject has active cystic acne.
- Subject has acne conglobata.
- Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
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% Topical Gel | Drug | Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel |
| BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% | Drug | BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% |
| Placebo | Drug | Placebo topical gel |
Primary outcome
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
Time frame: Baseline and 10 Weeks
The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
Time frame: Baseline and 10 Weeks
The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- 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.
Mahesh V Deshpande study director
Glenmark Pharmaceuticals Ltd
15 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 Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% in people with Acne Vulgaris, run by Glenmark Pharmaceuticals Ltd. India at 15 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 2 inclusion and 4 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 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Belize. 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 28 Jun 2017). 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?
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) (time frame: Baseline and 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 28 Jun 2017.