Acne VulgarisPhase 3NCT02616614
Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris
A Phase 3 study testing Onexton and Clindamycin/benzoyl peroxide gel in people with Acne Vulgaris, run by Actavis Inc. at 17 sites in United States.
Trial summary
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Onexton and Clindamycin/benzoyl peroxide gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 862 participants
- Where
- 17 sitesUnited States
- Study dates
- May 2015to Nov 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
- Healthy volunteers accepted
- 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
- On the face, ≥25 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Counts of nodules and cysts should be reported separately and not included in the inflammatory or non-inflammatory lesion counts. Lesions involving the eyes and scalp should be excluded from the count. (Subjects may have acne lesions on other areas of the body (e.g., on the back)).
- Subjects must have Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4.
- Willing to refrain from use of all other topical acne medications or antibiotics during the 12 week treatment period. Subjects may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g. benzoyl peroxide, salicylic acid).
- Subjects who are 18 years of age or older must have provided Institutional Review Board (IRB) approved written informed consent. Subjects who are at least 12 years of age and less than 18 years of age must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the subject's legally acceptable representative (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable.
- Male subjects and Female subjects of childbearing potential must use accepted methods of birth control or must agree to practice abstinence, from study start to 30 days after the last administration of study drug. All female subjects are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), vaginal ring (NuvaRing®), Depo-Provera® (Medroxy progesterone acetate), double barrier methods (e.g., condom and spermicide) or intrauterine device (IUD).
- Female subjects of child bearing potential must have a negative urine pregnancy test at baseline.
- Subjects who use make-up 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 not change make-up brand/type or frequency of use throughout the study.
Who cannot join
- History of hypersensitivity or allergy to clindamycin or benzoyl peroxide and/or any of the study medication ingredients or lincomycin or any other allowed product used during the study.
- Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Patient is allowed to shave the excessive facial hair at least a day before visiting the site for study assessments.
- Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day.
- Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
- Use on the face within 1 month prior to baseline or during the study of: 1) cryodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
Show all 26Show fewer
- Use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris or 5) systemic anti-inflammatory agents.
- Use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti- inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.
- Subjects who have acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
- Female subjects who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 4 and 30 days post visit 4) will be excluded from study participation.
- Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline will be excluded from study participation.
- Subjects who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation.
- Subjects who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, subjects who have any malignancy of the skin of the facial area will be excluded from study participation.
- Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold, will be excluded from study participation.
- Subjects who have facial sunburn will be excluded from study participation
- Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids and cocaine) as judged by their medical history will be excluded from study participation.
- History or presence of significant smoking (more than 10 cigarettes or any other form of tobacco smoking/day or consumption of tobacco products).
- Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg, Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg and Pulse rate less than 50 beats/minute or more than 100 beats/minute.
- Subjects who have participated in an investigational drug study (i.e., subjects have been treated with an investigational drug) within 1 month prior to baseline will be excluded from study participation. Subjects who are participating in non- treatment studies such as observational studies or registry studies can be considered for inclusion.
- Major illness, as per investigator's discretion, during 3 months before screening.
- Subjects who have been previously enrolled in this study will be excluded from study participation.
- Subjects who have had laser therapy and electrodesiccation to the facial area within 180 days prior to study entry will be excluded from participation.
- Subjects who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry will be excluded from participation.
- Subjects who have had general anesthesia for any reason and subjects who have received neuromuscular blocking agents within 14 days prior to study entry will be excluded from study participation.
- Subjects who have a baseline score of 3 (severe, marked/intense) as per the Application Site Reaction Scale (Section 5.2) will be excluded from participation.
- Any employees or staff of the research site are excluded from study participation.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Heartland Research Assoc
Augusta, Kansas, 67010
Discover Research
Beaumont, Texas, 77701
DiscoverResearch Inc
Bryan, Texas, 77802
Estudy
Chula Vista, California, 91911
Sterling Research Group
Cincinnati, Ohio, 45246
Tampa Bay Medical Research
Clearwater, Florida, 33761
Reseacr Across America
Dallas, Texas, 75234
Dermatology Consulting Services
High Point, North Carolina, 27262
Estudy
La Mesa, California, 91942
AMB Research Center
Miami, Florida, 33144
Meridian Clinical Research
Norfolk, Nebraska, 68701
Clinical Research Assoc. of Tidewater
Norfolk, Virginia, 23507
Meridian Clinical Research
Omaha, Nebraska, 68134
Alliance Dermatology
Phoenix, Arizona, 85032
Meridian Clinical Research
Savannah, Georgia, 31406
Sundance Clinical Research
St Louis, Missouri, 63141
Heartland Research Assoc
Wichita, Kansas, 67207
About this study
Official title: Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Bioequivalence of a Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel to Onexton® Gel in Subjects With Acne Vulgaris
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris
Read the detailed description
This is a randomized, double blind, three-arm, parallel group, placebo control bioequivalence study with clinical endpoint, at multiple study sites, designed to establish bioequivalence of clindamycin 1.2% and benzoyl peroxide 3.75% gel of Actavis and Onexton® (clindamycin 1.2% and benzoyl peroxide 3.75%) gel in the treatment of subjects with Acne Vulgaris.
The primary objective is to evaluate the bioequivalence of a generic of clindamycin 1.2% and benzoyl peroxide 3.75% gel to Onexton® in the treatment of subjects with acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Onexton, Clindamycin/benzoyl peroxide 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.
OnextonDrug
Also called Clindamycin/benzoyl peroxide gel
Topical gel for treating acne
Clindamycin/benzoyl peroxide gelDrug
Also called Clindamcyin Phosphate, BPO
Generic Clindamycin/benzoyl peroxide gel for treating acne
PlaceboDrug
Also called Vehicle
Vehicle gel used as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Onexton gel | Active comparator | Clindamycin 1.2% and benzoyl peroxide 3.75% topical gel Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily Receives: Drug: Onexton |
| Clindamycin/benzoyl peroxide gel | Experimental | Generic clindamycin 1.2% and benzoyl peroxide 3.75% topical gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily Receives: Drug: Clindamycin/benzoyl peroxide gel |
| Placebo | Placebo comparator | A vehicle gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts
Percent change from baseline to Week 12 (Day 84) in the inflammatory (papules and pustules) lesion count in PP Population.
Measured: 12 weeks
Percent Change in the Non-Inflammatory (Open and Closed Comedomes) Lesion Counts
One of the co-primary endpoints was the percent change from baseline to Week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion counts in PP Population.
Measured: 12 weeks
Secondary outcomes (1)
Number of Subjects With Treatment Success at Week 12
The secondary efficacy endpoint was the IGA score, expressed in terms of proportion of subjects with treatment success or failure at Week 12, where "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 posted30 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionNov 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, Investigator, Outcomes assessor
- Enrolment
- 862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry lau, PhD, Study director, Actavis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616614
- Sponsor's protocol ID
- WAT/CMBP/2015
- Status last verified
- May 2020
- First submitted
- 25 Nov 2015
- Last updated
- 27 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Bioequivalence of a Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel to Onexton® Gel in Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02616614
- Acronym / sponsor ID
- WAT/CMBP/2015
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 862 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Posted 27 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris
Detailed description
This is a randomized, double blind, three-arm, parallel group, placebo control bioequivalence study with clinical endpoint, at multiple study sites, designed to establish bioequivalence of clindamycin 1.2% and benzoyl peroxide 3.75% gel of Actavis and Onexton® (clindamycin 1.2% and benzoyl peroxide 3.75%) gel in the treatment of subjects with Acne Vulgaris.
The primary objective is to evaluate the bioequivalence of a generic of clindamycin 1.2% and benzoyl peroxide 3.75% gel to Onexton® in the treatment of subjects with acne vulgaris.
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 |
|---|---|---|
| Onexton gel | Active comparator | Drug: OnextonClindamycin 1.2% and benzoyl peroxide 3.75% topical gel Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily |
| Clindamycin/benzoyl peroxide gel | Experimental | Drug: Clindamycin/benzoyl peroxide gelGeneric clindamycin 1.2% and benzoyl peroxide 3.75% topical gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily |
| Placebo | Placebo comparator | Drug: PlaceboA vehicle gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
- On the face, ≥25 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Counts of nodules and cysts should be reported separately and not included in the inflammatory or non-inflammatory lesion counts. Lesions involving the eyes and scalp should be excluded from the count. (Subjects may have acne lesions on other areas of the body (e.g., on the back)).
- Subjects must have Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4.
- Willing to refrain from use of all other topical acne medications or antibiotics during the 12 week treatment period. Subjects may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g. benzoyl peroxide, salicylic acid).
- Subjects who are 18 years of age or older must have provided Institutional Review Board (IRB) approved written informed consent. Subjects who are at least 12 years of age and less than 18 years of age must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the subject's legally acceptable representative (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable.
Key exclusion criteria (26 listed)
- History of hypersensitivity or allergy to clindamycin or benzoyl peroxide and/or any of the study medication ingredients or lincomycin or any other allowed product used during the study.
- Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Patient is allowed to shave the excessive facial hair at least a day before visiting the site for study assessments.
- Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day.
- Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
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 |
|---|---|---|
| OnextonAlso: Clindamycin/benzoyl peroxide gelTopical gel for treating acne | Drug | Onexton gel |
| Clindamycin/benzoyl peroxide gelAlso: Clindamcyin Phosphate, BPOGeneric Clindamycin/benzoyl peroxide gel for treating acne | Drug | Clindamycin/benzoyl peroxide gel |
| PlaceboAlso: VehicleVehicle gel used as a placebo | Drug | Placebo |
Primary outcome
Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts
Time frame: 12 weeks
Percent change from baseline to Week 12 (Day 84) in the inflammatory (papules and pustules) lesion count in PP Population.
Percent Change in the Non-Inflammatory (Open and Closed Comedomes) Lesion Counts
Time frame: 12 weeks
One of the co-primary endpoints was the percent change from baseline to Week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion counts in PP Population.
1 secondary outcome
Number of Subjects With Treatment Success at Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- 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.
Henry lau, PhD study director
Actavis Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Onexton and Clindamycin/benzoyl peroxide gel in people with Acne Vulgaris, run by Actavis Inc. at 17 sites in United States.
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 8 inclusion and 26 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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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 27 May 2020). 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 in the Inflammatory (Papules and Pustules) 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 27 May 2020.