Acne VulgarisPhase 1NCT02595034
A Study CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® Gel in the Treatment of Acne Vulgaris
A Phase 1 study testing Clindamycin and Benzoyl Peroxide Gel 1%5% and BenzaClin® Topical Gel in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..
Trial summary
This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel 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%5% and BenzaClin® Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 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 nonpregnant 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).
- 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 10week treatment period.
- If female of childbearing potential, willing to use an acceptable form of birth control during the study.
Who cannot join
- 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 (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
- 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 (multivitamins are allowed).
- 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 or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
- Use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), 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.
About this study
Official title: A Randomized Double Blind Multiple Center Placebo Controlled Study Comparing CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel in the Treatment of Acne Vulgaris
This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel
Read the detailed description
The objectives of this study are to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% (Taro Pharmaceuticals Inc.) and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, US) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control
- Conditions
- Acne Vulgaris
- Being tested
- Clindamycin and Benzoyl Peroxide Gel 1%5%, BenzaClin® Topical 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%5%Drug
Also called Active
Clindamycin and Benzoyl Peroxide Gel 1%5% (Taro Pharmaceuticals Inc.)
BenzaClin® Topical GelDrug
Also called Active
BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, U.S.)
PlaceboDrug
Also called Vehicle
Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin/BP Gel 1%5% | Experimental | Clindamycin and Benzoyl Peroxide Gel 1%/5% applied twice daily (morning and evening) for 70 days (10 weeks). Receives: Drug: Clindamycin and Benzoyl Peroxide Gel 1%5% |
| BenzaClin® Topical Gel | Active comparator | BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel applied twice daily (morning and evening) for 70 days (10 weeks). Receives: Drug: BenzaClin® Topical Gel |
| Placebo | Placebo comparator | Placebo (vehicle of the test product) applied twice daily (morning and evening) for 70 days (10 weeks). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory lesion count
Mean percent change from baseline to week 10 (study day 70) in the inflammatory (papules and pustules) lesion counts.
Measured: Week 10 (day 70)
Change in non-inflammatory lesion count
Mean percent change from baseline to week 10 (study day 70) in the non-inflammatory (open and closed comedones) lesion counts.
Measured: Week 10 (day 70)
Secondary outcomes (1)
Clinical response of success
The proportion of subjects with a clinical response of success at week 10 (study day 70) defined as an Investigator's Global Assessment score at least 2 grades less than baseline assessment.
Measured: Week 10 (day 70)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJan 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.
- 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
- 1,000 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
- NCT02595034
- Sponsor's protocol ID
- CLBG 1412
- Status last verified
- May 2017
- First submitted
- 1 Nov 2015
- Last updated
- 4 May 2017
- 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 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Multiple Center Placebo Controlled Study Comparing CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02595034
- Acronym / sponsor ID
- CLBG 1412
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Nov 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.
This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel
Detailed description
The objectives of this study are to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% (Taro Pharmaceuticals Inc.) and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, US) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the 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/BP Gel 1%5% | Experimental | Drug: Clindamycin and Benzoyl Peroxide Gel 1%5%Clindamycin and Benzoyl Peroxide Gel 1%/5% applied twice daily (morning and evening) for 70 days (10 weeks). |
| BenzaClin® Topical Gel | Active comparator | Drug: BenzaClin® Topical GelBenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel applied twice daily (morning and evening) for 70 days (10 weeks). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (vehicle of the test product) applied twice daily (morning and evening) for 70 days (10 weeks). |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy male or nonpregnant 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).
- 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 10week treatment period.
- If female of childbearing potential, willing to use an acceptable form of birth control during the study.
Key exclusion criteria (8 listed)
- 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 (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
- 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 (multivitamins are allowed).
- 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 |
|---|---|---|
| Clindamycin and Benzoyl Peroxide Gel 1%5%Also: ActiveClindamycin and Benzoyl Peroxide Gel 1%5% (Taro Pharmaceuticals Inc.) | Drug | Clindamycin/BP Gel 1%5% |
| BenzaClin® Topical GelAlso: ActiveBenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, U.S.) | Drug | BenzaClin® Topical Gel |
| PlaceboAlso: VehiclePlacebo (vehicle of the test product) (Taro Pharmaceuticals Inc.) | Drug | Placebo |
Primary outcome
Change in inflammatory lesion count
Time frame: Week 10 (day 70)
Mean percent change from baseline to week 10 (study day 70) in the inflammatory (papules and pustules) lesion counts.
Change in non-inflammatory lesion count
Time frame: Week 10 (day 70)
Mean percent change from baseline to week 10 (study day 70) in the non-inflammatory (open and closed comedones) lesion counts.
1 secondary outcome
Clinical response of success
Time frame: Week 10 (day 70)
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 4 May 2017.
- 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%5% and BenzaClin® 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 8 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 4 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?
Change in inflammatory lesion count (time frame: Week 10 (day 70)). 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 4 May 2017.