Acne VulgarisPhase 1NCT01769664
A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris
A Phase 1 study testing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Duac® Topical Gel in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The objective of this study is to compare the relative efficacy and safety of the test formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to the marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in the treatment of the inflamed lesions of acne… 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 Duac® Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Aug 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
- Male or non-pregnant, non-lactating female, between 12 and 40 years of age with a clinical diagnosis of acne vulgaris.
- Signed informed consent form. For a minor, the parent or legal guardian will sign the consent form and patient will sign assent to participate form.
- If female of child-bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study. Patients on hormonal contraceptives must have been on the same for three months prior to baseline visit and continue throughout the duration of the study.
- Have facial acne with 20 or more facial inflammatory lesions and 25 or more non-inflammatory lesions and 2 or less nodulocystic lesions and have an Investigator Global Assessment score of 2, 3 or 4.
- Willing to comply with the study requirements and restrictions including refraining from the use of all other topical acne medications or antibiotics during the treatment period.
Who cannot join
- Patient has more than 2 facial nodular lesions.
- Patient has active cystic acne.
- Patient has acne conglobata.
- Patients with excessive facial hair that would interfere with the diagnosis or assessment of acne.
- Patients with tatoos or excessive facial scarring that may interfere with the evaluation of the patient's acne.
- Patients with active facial sunburn, peeling due to sunburn and patients who will be exposed to excessive sunlight during the study.
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- Any skin condition other than acne vulgaris that would interfere with the evaluation of the patient's acne.
- Females who are pregnant, lactating or likely to become pregnant during the study.
- Patients with a history of or active colitis other than irritable bowel syndrome.
- History of allergy or hypersensitivity to Clindamycin, Lincomycin or benzoyl peroxide or history of any drug hypersensitivity or intolerance which would compromise the patient's safety or the study.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that would place the patient at undue risk by participation.
- Use on the face within 1 month prior to screening/baseline or during the study of the following: cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, x-ray therapy.
- Use of the following within 1 month prior to screening/baseline: spironolactone, systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids which require a 6 month washout), systemic anti-inflammatory agents.
- Use of oral isotretinoin (Accutane®) or oral retinoids within 6 months, or therapeutic vitamin A supplements greater than 10,000 units/day.
- Use within 2 weeks prior to screening/baseline of the following: topical steroids, topical retinoids, topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, medicated cleansers, topical antibiotics.
- Receipt of any drug as part of a research study within 30 days.
- Female patients taking hormonal contraceptives or oral estrogen for less than 3 months and those that plan to change the dosage regimen during the course of the study.
- Previous participation in this study.
- Employees of the investigator or research center or their immediate family members.
About this study
Official title: A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to Duac® Topical Gel Clindamycin 1%/Benzoyl Peroxide 5% (Stiefel) in the Treatment of Acne Vulgaris
The objective of this study is to compare the relative efficacy and safety of the test formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to the marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in the treatment of the inflamed lesions of acne vulgaris. Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel, Duac® Topical Gel, Placebo Topical Gel
- Keywords
- Acne vulgaris, Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel, Duac® Topical 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 1%/Benzoyl Peroxide 5% Topical GelDrug
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)
Duac® Topical GelDrug
Duac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel) applied once a day in the evening for 77 days (11 weeks)
Placebo Topical GelDrug
Placebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel | Experimental | Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) Receives: Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel |
| Duac® Topical Gel | Active comparator | Duac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel) Receives: Drug: Duac® Topical Gel |
| Placebo Topical Gel | Placebo comparator | Placebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.) Receives: Drug: Placebo Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence of test gel to reference gel
Bioequivalence will be determined by evaluating the mean percent change from baseline to week 11 in the number of inflammatory lesions.
Measured: Week 11 (study day 77)
Secondary outcomes (1)
Superiority against placebo
The superiority of the test and reference against the placebo will be tested for the mean percent reduction in inflamed lesion count at week 11.
Measured: Week 11 (study day 77)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2013
- Study completionAug 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
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769664
- Sponsor's protocol ID
- CLBG 1209
- Status last verified
- Jan 2014
- First submitted
- 11 Oct 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to Duac® Topical Gel Clindamycin 1%/Benzoyl Peroxide 5% (Stiefel) in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01769664
- Acronym / sponsor ID
- CLBG 1209
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel, Duac® Topical Gel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 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 relative efficacy and safety of the test formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to the marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in the treatment of the inflamed lesions of acne vulgaris. Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel | Experimental | Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical GelClindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) |
| Duac® Topical Gel | Active comparator | Drug: Duac® Topical GelDuac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel) |
| Placebo Topical Gel | Placebo comparator | Drug: Placebo Topical GelPlacebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.) |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or non-pregnant, non-lactating female, between 12 and 40 years of age with a clinical diagnosis of acne vulgaris.
- Signed informed consent form. For a minor, the parent or legal guardian will sign the consent form and patient will sign assent to participate form.
- If female of child-bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study. Patients on hormonal contraceptives must have been on the same for three months prior to baseline visit and continue throughout the duration of the study.
- Have facial acne with 20 or more facial inflammatory lesions and 25 or more non-inflammatory lesions and 2 or less nodulocystic lesions and have an Investigator Global Assessment score of 2, 3 or 4.
- Willing to comply with the study requirements and restrictions including refraining from the use of all other topical acne medications or antibiotics during the treatment period.
Key exclusion criteria (19 listed)
- Patient has more than 2 facial nodular lesions.
- Patient has active cystic acne.
- Patient has acne conglobata.
- Patients with excessive facial hair that would interfere with the diagnosis or assessment of acne.
- Patients with tatoos or excessive facial scarring that may interfere with the evaluation of the patient's 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 GelClindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks) | Drug | Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel |
| Duac® Topical GelDuac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel) applied once a day in the evening for 77 days (11 weeks) | Drug | Duac® Topical Gel |
| Placebo Topical GelPlacebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks) | Drug | Placebo Topical Gel |
Primary outcome
Bioequivalence of test gel to reference gel
Time frame: Week 11 (study day 77)
Bioequivalence will be determined by evaluating the mean percent change from baseline to week 11 in the number of inflammatory lesions.
1 secondary outcome
Superiority against placebo
Time frame: Week 11 (study day 77)
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 22 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Duac® Topical 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 5 inclusion and 19 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 22 Jan 2014. 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?
Bioequivalence of test gel to reference gel (time frame: Week 11 (study day 77)). 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 22 Jan 2014.