Acne VulgarisPhase 3NCT01788384
Evaluate Therapeutic Equivalence and Safety of Two Clindamycin Phosphate and Benzoyl Peroxide Gels in Acne Vulgaris
A Phase 3 study testing Clindamycin Phosphate / Benzoyl Peroxide Gel and Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% in people with Acne Vulgaris, run by Watson Laboratories, Inc..
Trial summary
Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel marketed by Valeant Pharmaceuticals, North America, is a safe and effective topical therapy used for the treatment of acne vulgaris. 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 / Benzoyl Peroxide Gel and Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 708 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Dec 2012
- Phase
- Phase 3
- 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
- ≥ 12 and ≤ 40 years
- Diagnosis of acne vulgaris (acne)
- >18 years and provide written informed consent
- Ages 12 to 17 and provide written assent and written informed consent from patient's legal representative
- Must sign a HIPAA authorization
Show all 17Show fewer
- Minimum ≥ 25 non-inflammatory lesions
- ≥ 20 inflammatory lesions
- ≤ 2 nodulocystic lesions on the face
- Acne of severity grade 2, 3, or 4 -Investigator's Global Assessment (IGA)
- Refrain from all other topical acne medications or antibiotics during the 12-week treatment period except Investigational Product
- All Female patients with a negative urine pregnancy test who use birth control from the study start to 30 days after the last administration of study drug
- All male patients who use birth control with their partners, from the study start to 30 days after the last administration of study drug. Abstinence is acceptable. Female partners should use birth control
- Must be willing and able to understand and comply with the protocol requirements and required study visits
- In good health
- Free from any clinically significant disease
- Must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to use the same make-up, brand/type and maintain the same frequency of use throughout the study
Who cannot join
- Female patients who are pregnant, nursing or planning to become pregnant during study
- History or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis
- Hypersensitivity or allergy to benzoyl peroxide, clindamycin and/or any of the study medication ingredients
- Presence of any skin condition that would interfere with the diagnosis or assessment
- Excessive facial hair
- Wax epilation of the face within 14 days prior
Show all 25Show fewer
- Used oral retinoids or therapeutic vitamin A supplements of >10,000 units/day (multivitamins are allowed) within 6 months prior to or during the study
- Estrogens or oral contraceptives for <3 months prior to baseline; Use of such therapy must remain constant throughout the study
- Cryodestruction, chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, X-ray therapy procedures performed on the face within 1 month prior to or during the study
- Any systemic (steroids, antibiotics treatment for acne, anti-inflammatory agents) treatments within 1 month prior to baseline or during the study
- Any (topical steroids, topical retinoids, α-hydroxy/glycolic acid, benzoyl peroxide, topical anti-inflammatory agents, topical antibiotics) treatments within 2 weeks prior to baseline or during the study:
- Intend to use Spironolactone
- Intend to use tanning booths, sunbathing, or excessive exposure to the sun
- Radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline
- Unstable clinically significant medical disorders or life-threatening diseases
- On-going malignancies requiring systemic treatment
- Any malignancy of the facial area skin
- Engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes
- Consume excessive amounts of alcohol or use drugs of abuse
- Participation in an investigational drug study within 30 days prior
- Are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion
- Previously enrolled in this study
- Laser therapy, electrodessication and phototherapy to the facial area within 180 days prior to study entry
- Cosmetic procedures which may affect the efficacy and safety profile of the study drug within 14 days prior to study entry
- Currently have or have recently had bacterial folliculitis on the face
About this study
Official title: A Multicenter, Double-blind, Randomized, Vehicle-controlled, Parallel-group Study Comparing Clindamycin Phosphate and Benzoyl Peroxide Gel and Acanya® 1.2%/2.5% and Both Active Treatments to Vehicle Control for Treating Acne Vulgaris
Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel marketed by Valeant Pharmaceuticals, North America, is a safe and effective topical therapy used for the treatment of acne vulgaris.
Read the detailed description
Watson Laboratories, Inc. has developed a generic formulation of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%,and the current study is designed to evaluate the safety and efficacy of this formulation to determine if it is bioequivalent to Acanya.
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin Phosphate / Benzoyl Peroxide Gel, Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, Placebo (Vehicle Gel)
- Keywords
- acne, Clindamycin Phosphate/Benzoyl Peroxide, Acanya, Mild to severe acne vulgaris
- 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 / Benzoyl Peroxide GelDrug
Also called Generic
Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%Drug
Also called Acanya
Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.
Placebo (Vehicle Gel)Drug
Also called Vehicle Gel
Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.
| Study group | Role | What they receive |
|---|---|---|
| Acanya | Active comparator | Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel (Valeant Pharmaceuticals, North America) Receives: Drug: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% |
| Clindamycin Phosphate / Benzoyl Peroxide | Experimental | Clindamycin Phosphate / Benzoyl Peroxide Gel, 1.2%/2.5% Receives: Drug: Clindamycin Phosphate / Benzoyl Peroxide Gel |
| Vehicle Gel | Placebo comparator | Placebo (Vehicle Gel)of the test product (Watson Laboratories, Inc.) Receives: Drug: Placebo (Vehicle Gel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of the primary endpoint will be based on the mean percent changes from baseline to week 12 in the inflammatory (papules and pustules) lesion counts and in the non-inflammatory (comedones) lesion counts.
Measured: Week 12
Secondary outcomes (1)
The proportion of subjects with a clinical response of "success" at Week 12 using IGA.
The proportion of subjects with a clinical response of "success" at Week 12. Success was defined as an IGA score that was 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 posted11 Feb 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John L Capicchioni, Study director, Akesis, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788384
- Sponsor's protocol ID
- 12-1001
- Status last verified
- Feb 2013
- First submitted
- 7 Feb 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. 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 Clindamycin Phosphate and Benzoyl Peroxide Gel and Acanya® 1.2%/2.5% and Both Active Treatments to Vehicle Control for Treating Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01788384
- Acronym / sponsor ID
- 12-1001
- Conditions
- Acne Vulgaris
- Keywords
- acne, Clindamycin Phosphate/Benzoyl Peroxide, Acanya, Mild to severe acne vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Watson Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Feb 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.
Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel marketed by Valeant Pharmaceuticals, North America, is a safe and effective topical therapy used for the treatment of acne vulgaris.
Detailed description
Watson Laboratories, Inc. has developed a generic formulation of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%,and the current study is designed to evaluate the safety and efficacy of this formulation to determine if it is bioequivalent to Acanya.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acanya | Active comparator | Drug: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel (Valeant Pharmaceuticals, North America) |
| Clindamycin Phosphate / Benzoyl Peroxide | Experimental | Drug: Clindamycin Phosphate / Benzoyl Peroxide GelClindamycin Phosphate / Benzoyl Peroxide Gel, 1.2%/2.5% |
| Vehicle Gel | Placebo comparator | Drug: Placebo (Vehicle Gel)Placebo (Vehicle Gel)of the test product (Watson Laboratories, Inc.) |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Healthy male or non pregnant female
- ≥ 12 and ≤ 40 years
- Diagnosis of acne vulgaris (acne)
- >18 years and provide written informed consent
- Ages 12 to 17 and provide written assent and written informed consent from patient's legal representative
Key exclusion criteria (25 listed)
- Female patients who are pregnant, nursing or planning to become pregnant during study
- History or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis
- Hypersensitivity or allergy to benzoyl peroxide, clindamycin and/or any of the study medication ingredients
- Presence of any skin condition that would interfere with the diagnosis or assessment
- Excessive facial hair
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 / Benzoyl Peroxide GelAlso: GenericDosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes. | Drug | Clindamycin Phosphate / Benzoyl Peroxide |
| Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%Also: AcanyaDosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes. | Drug | Acanya |
| Placebo (Vehicle Gel)Also: Vehicle GelDosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes. | Drug | Vehicle Gel |
Primary outcome
The evaluation of the primary endpoint will be based on the mean percent changes from baseline to week 12 in the inflammatory (papules and pustules) lesion counts and in the non-inflammatory (comedones) lesion counts.
Time frame: Week 12
1 secondary outcome
The proportion of subjects with a clinical response of "success" at Week 12 using IGA.
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 11 Feb 2013.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
John L Capicchioni study director
Akesis, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clindamycin Phosphate / Benzoyl Peroxide Gel and Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% in people with Acne Vulgaris, run by Watson Laboratories, 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 17 inclusion and 25 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 11 Feb 2013. 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?
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?
The evaluation of the primary endpoint will be based on the mean percent changes from baseline to week 12 in the inflammatory (papules and pustules) lesion counts and in the non-inflammatory (comedones) lesion counts. (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 11 Feb 2013.