Acne VulgarisPhase 1NCT02411955
A Study Comparing Tazarotene Cream 0.1% to Tazorac® and Both to a Placebo Control in the Treatment of Acne Vulgaris
A Phase 1 study testing Tazarotene Cream 0.1% and Tazorac® in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%). 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?
- Tazarotene Cream 0.1% and Tazorac®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,077 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Feb 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 non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.
- Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
- Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.
Who cannot join
- Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
- Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
About this study
Official title: A Multiple-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to Tazorac® (Tazarotene Cream 0.1%) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).
Read the detailed description
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%) in the treatment of acne vulgaris and to demonstrate the superiority of the test and reference products over the placebo control.
- Conditions
- Acne Vulgaris
- Being tested
- Tazarotene Cream 0.1%, Tazorac®, 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.
Tazarotene Cream 0.1%Drug
Also called Tazarotene
Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.
Tazorac®Drug
Also called Tazarotene
Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.
PlaceboDrug
Also called Vehicle
Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Tazarotene Cream 0.1% | Experimental | Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.) Receives: Drug: Tazarotene Cream 0.1% |
| Tazorac® | Active comparator | Tazorac® (tazarotene cream 0.1%) (Allergan LLC) Receives: Drug: Tazorac® |
| Placebo | Placebo comparator | Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory lesion counts
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Measured: Week 12
Change in non-inflammatory lesion counts
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Measured: Week 12
Secondary outcomes (1)
Clinical response of success
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionFeb 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
- 1,077 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
- NCT02411955
- Sponsor's protocol ID
- TAZC 1308
- Status last verified
- May 2017
- First submitted
- 4 Apr 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- 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 Multiple-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to Tazorac® (Tazarotene Cream 0.1%) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02411955
- Acronym / sponsor ID
- TAZC 1308
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Apr 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.
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).
Detailed description
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%) in the treatment of acne vulgaris and to demonstrate the superiority 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 |
|---|---|---|
| Tazarotene Cream 0.1% | Experimental | Drug: Tazarotene Cream 0.1%Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.) |
| Tazorac® | Active comparator | Drug: Tazorac®Tazorac® (tazarotene cream 0.1%) (Allergan LLC) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (Vehicle of the 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 (4 listed)
- Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.
- Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
- Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.
Key exclusion criteria (3 listed)
- Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
- Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
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 |
|---|---|---|
| Tazarotene Cream 0.1%Also: TazaroteneTazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days. | Drug | Tazarotene Cream 0.1% |
| Tazorac®Also: TazaroteneTazorac® applied to lightly cover the entire face once daily for 84 consecutive days. | Drug | Tazorac® |
| PlaceboAlso: VehiclePlacebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days. | Drug | Placebo |
Primary outcome
Change in inflammatory lesion counts
Time frame: Week 12
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in non-inflammatory lesion counts
Time frame: Week 12
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: Week 12
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 Tazarotene Cream 0.1% and Tazorac® 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 4 inclusion and 3 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 counts (time frame: Week 12). 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.