Acne VulgarisPhase 1NCT01769235
Study Comparing Clindamycin Phosphate and Benzoyl Peroxide Gel to Acanya® Gel and Both to a Vehicle Control in the Treatment of Acne Vulgaris
A Phase 1 study testing Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% and Acanya® Gel, 1.2%/2.5% in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The objective of this study is to compare the safety and efficacy profiles of Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% to Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% and to demonstrate the superior efficacy of the two active formulations over that of… 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 Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% and Acanya® Gel, 1.2%/2.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,215 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Dec 2013
- 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
- Be willing and able to provide written informed consent/assent for the study.
- Be 12 to 40 years of age, inclusive. A subject may be of either sex and any race/ethnicity.
- Have a clinical diagnosis of facial acne vulgaris with 25 or greater non-inflammatory lesions and 20 or greater inflammatory lesions and no more than 2 nodulocystic lesions.
- Have a baseline Investigator's Global Assessment of acne severity grade of 2, 3 or 4 on a severity scale of 0 to 4.
- Be willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, refrain from use of all other topical acne medication and topical antibiotics during the 12-week treatment period, return for the required treatment period visits, comply with therapy prohibitions, and able to complete the study.
- Be in general good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
- Female subjects of childbearing potential must have a negative urine pregnancy test amd must be willing to use a medically accepted method of contraception during the study.
Who cannot join
- Presence of more than 2 facial nodulocystic lesions (i.e., nodules and cysts).
- Current diagnosis of acne conglobata, acne fulminans, or secondary acne.
- Presence of active cystic acne, or polycystic ovarian syndrome.
- History or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
- Presence of any other facial skin condition that might interfere with acne vulgaris diagnosis and/or assessment.
- Excessive facial hair that would interfere with diagnosis or assessment of acne vulgaris.
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- History of unresponsiveness to topical clindamycin phosphate and/or benzoyl peroxide therapy.
- Start or change of dose of estrogens or hormonal treatment 3 months prior to baseline or throughout the study.
- Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days of study entry and throughout the study.
- Use of any of the following treatments more recently than the indicated washout period prior to visit 1/day 1; need or intent to continue to use any of the following treatments during the study: oral retinoids or therapeutic Vitamin A supplements of greater than 10,000 units/day; systemic steroids; systemic antibiotics; systemic treatment for acne vulgaris ; systemic anti-inflammatory or immunosuppressive agents (NSAID use is allowed on an as-needed basis but for no more than 7 days of consecutive use, low dose aspirin is allowed if on a stable dose for at least 30 days); Spironolactone; use on the face of cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, x-ray therapy; topical retinoids; topical steroids; topical anti-acne medications; topical anti-inflammatory agents; topical antibiotics; medicated cleansers; use of tanning booths, sun lamps, sunbathing or excessive exposure to the sun; antipruritics, including antihistamines.
- History of hypersensitivity or allergy to clindamycin phosphate, benzoyl peroxide, and /or any ingredient in the study medication.
- Females who are pregnant, breastfeeding, intending to become pregnant during the study, or who do not agree to use an acceptable form of birth control during the study.
- Consumption of excessive alcohol, abuse of drugs, or a condition that could compromise the subject's ability to comply with study requirements.
- Any clinically significant condition or situation other than acne vulgaris that would interfere with the study evaluations or optimal participation.
- Use of any investigational drugs within 30 days prior to visit 1/day 1.
- Participation in any other clinical study in the 30 days prior to signing the informed consent form.
- Previous participation in this study.
About this study
Official title: A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the Reference Listed Acanya® (Clindamycin Phosphate and Benzoyl Peroxide)Gel, 1.2%/2.5% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
The objective of this study is to compare the safety and efficacy profiles of Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% to Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% and to demonstrate the superior efficacy of the two active formulations over that of the vehicle in the treatment of acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, Acanya® Gel, 1.2%/2.5%, Vehicle of test product
- Keywords
- Acne Vulgaris, Clindamycin Phosphate and Benzoyl Peroxide Gel, Acanya® 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.
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%Drug
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% (Taro Pharmaceuticals Inc.)applied at approximately the same time once daily for 84 days (12 weeks).
Acanya® Gel, 1.2%/2.5%Drug
Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% (Dow Pharmaceutical Sciences, Inc., marketed by Valeant Pharmaceuticals North America LLC)applied at approximately the same time once daily for 84 days (12 weeks).
Vehicle of test productDrug
Vehicle of test product (Taro Pharmaceuticals Inc.)applied at approximately the same time once daily for 84 days (12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% | Experimental | Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% (Taro Pharmaceuticals Inc.) Receives: Drug: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% |
| Acanya® Gel, 1.2%/2.5% | Active comparator | Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% (Dow Pharmaceutical Sciences, Inc., marketed by Valeant Pharmaceuticals North America LLC) Receives: Drug: Acanya® Gel, 1.2%/2.5% |
| Vehicle of test product | Placebo comparator | Vehicle of test product (Taro Pharmaceuticals Inc.) Receives: Drug: Vehicle of test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change in inflammatory lesion counts.
Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts.
Measured: 12 weeks
Mean percent change in non-inflammatory lesion counts.
Mean percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts.
Measured: 12 weeks
Secondary outcomes (1)
Clinical response of "success".
The proportion of subjects at week 12 with a clinical response of "success" is defined as an Investigators Global Assessment score that is at least 2 grades less than the baseline assessment.
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 posted16 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionDec 2013
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
- 1,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Symbio CRO, Study chair, http://symbioresearch.com/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769235
- Sponsor's protocol ID
- CLBG 1210
- Status last verified
- May 2017
- First submitted
- 14 Jan 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the Reference Listed Acanya® (Clindamycin Phosphate and Benzoyl Peroxide)Gel, 1.2%/2.5% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01769235
- Acronym / sponsor ID
- CLBG 1210
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris, Clindamycin Phosphate and Benzoyl Peroxide Gel, Acanya® Gel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,215 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Jan 2013 (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 objective of this study is to compare the safety and efficacy profiles of Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% to Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% and to demonstrate the superior efficacy of the two active formulations over that of the vehicle in the treatment of acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% | Experimental | Drug: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% (Taro Pharmaceuticals Inc.) |
| Acanya® Gel, 1.2%/2.5% | Active comparator | Drug: Acanya® Gel, 1.2%/2.5%Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% (Dow Pharmaceutical Sciences, Inc., marketed by Valeant Pharmaceuticals North America LLC) |
| Vehicle of test product | Placebo comparator | Drug: Vehicle of test productVehicle of test product (Taro Pharmaceuticals Inc.) |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Be willing and able to provide written informed consent/assent for the study.
- Be 12 to 40 years of age, inclusive. A subject may be of either sex and any race/ethnicity.
- Have a clinical diagnosis of facial acne vulgaris with 25 or greater non-inflammatory lesions and 20 or greater inflammatory lesions and no more than 2 nodulocystic lesions.
- Have a baseline Investigator's Global Assessment of acne severity grade of 2, 3 or 4 on a severity scale of 0 to 4.
- Be willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, refrain from use of all other topical acne medication and topical antibiotics during the 12-week treatment period, return for the required treatment period visits, comply with therapy prohibitions, and able to complete the study.
Key exclusion criteria (17 listed)
- Presence of more than 2 facial nodulocystic lesions (i.e., nodules and cysts).
- Current diagnosis of acne conglobata, acne fulminans, or secondary acne.
- Presence of active cystic acne, or polycystic ovarian syndrome.
- History or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
- Presence of any other facial skin condition that might interfere with acne vulgaris diagnosis and/or assessment.
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 Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% (Taro Pharmaceuticals Inc.)applied at approximately the same time once daily for 84 days (12 weeks). | Drug | Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% |
| Acanya® Gel, 1.2%/2.5%Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% (Dow Pharmaceutical Sciences, Inc., marketed by Valeant Pharmaceuticals North America LLC)applied at approximately the same time once daily for 84 days (12 weeks). | Drug | Acanya® Gel, 1.2%/2.5% |
| Vehicle of test productVehicle of test product (Taro Pharmaceuticals Inc.)applied at approximately the same time once daily for 84 days (12 weeks). | Drug | Vehicle of test product |
Primary outcome
Mean percent change in inflammatory lesion counts.
Time frame: 12 weeks
Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts.
Mean percent change in non-inflammatory lesion counts.
Time frame: 12 weeks
Mean percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts.
1 secondary outcome
Clinical response of "success".
Time frame: 12 weeks
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 5 May 2017.
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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.
Symbio CRO study chair
http://symbioresearch.com/
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% and Acanya® Gel, 1.2%/2.5% 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 7 inclusion and 17 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 5 May 2017. 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?
Mean percent change in inflammatory lesion counts. (time frame: 12 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 5 May 2017.