Acne VulgarisPhase 1NCT02578043
A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris
A Phase 1 study testing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% and Onexton™ Gel in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The objectives of this study are to evaluate the therapeutic equivalence and safety. 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 and Benzoyl Peroxide Gel 1.2%/3.75% and Onexton™ Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 844 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
- Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.
Who cannot join
- Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
- A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
- A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.
About this study
Official title: A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
The objectives of this study are to evaluate the therapeutic equivalence and safety.
Read the detailed description
The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%, Onexton™ Gel, 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 and Benzoyl Peroxide Gel 1.2%/3.75%Drug
Also called Clindamycin, BPO
Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)
Onexton™ GelDrug
Also called Clindamycin, BPO
Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)
PlaceboDrug
Also called Vehicle
Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin and BPO Gel 1.2%/3.75% | Experimental | Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days. Receives: Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% |
| Onexton™ Gel | Active comparator | Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days. Receives: Drug: Onexton™ Gel |
| Placebo | Placebo comparator | Placebo (vehicle of the test product) applied to the face once daily for 84 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of Bioequivalence
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
Measured: Week 12
Secondary outcomes (1)
Clinical response of success
The proportion of subjects with a clinical response of success at week 12 defined as an Investigator's Global Assessment score that is at least 2 grades less than the baseline assessment.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 844 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catawba Research, Study chair, http://catawbaresearch.com/contact/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578043
- Sponsor's protocol ID
- CLBG 1508
- Status last verified
- May 2018
- First submitted
- 14 Oct 2015
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02578043
- Acronym / sponsor ID
- CLBG 1508
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 844 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate the therapeutic equivalence and safety.
Detailed description
The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clindamycin and BPO Gel 1.2%/3.75% | Experimental | Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days. |
| Onexton™ Gel | Active comparator | Drug: Onexton™ GelOnexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (vehicle of the test product) applied to the face once daily for 84 days. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
- Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.
Key exclusion criteria (3 listed)
- Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
- A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
- A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.
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 and Benzoyl Peroxide Gel 1.2%/3.75%Also: Clindamycin, BPOClindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.) | Drug | Clindamycin and BPO Gel 1.2%/3.75% |
| Onexton™ GelAlso: Clindamycin, BPOOnexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC) | Drug | Onexton™ Gel |
| PlaceboAlso: VehiclePlacebo (vehicle of the test product) (Taro Pharmaceuticals Inc.) | Drug | Placebo |
Primary outcome
Demonstration of Bioequivalence
Time frame: Week 12
Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
1 secondary outcome
Clinical response of success
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- 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.
Catawba Research study chair
http://catawbaresearch.com/contact/
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% and Onexton™ Gel in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..
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 3 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 May 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demonstration of Bioequivalence (time frame: Week 12). 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 May 2018; AzTrials last refreshed its copy on 1 Nov 2026.