Acne VulgarisPhase 3NCT02160678
Generic Tazarotene Cream, 0.1% in the Treatment of Acne Vulgaris
A Phase 3 study testing Tazarotene Cream, 0.1 % and Tazorac Cream, 0.1% in people with Acne Vulgaris, run by G & W Laboratories Inc. at 1 site in United States.
Trial summary
To compare the safety and efficacy profiles of Tazarotene Cream, 0.1 % to the reference listed drug Tazorac® (tazarotene) Cream, 0.1 % in order to demonstrate bioequivalence, and to demonstrate superiority of the 2 active creams over that of the cream vehicle (placebo) in the treatment of 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?
- Tazarotene Cream, 0.1 % and Tazorac Cream, 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,741 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 2015
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be willing and able to provide written informed consent/assent for the study.
- Be a healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years of age, inclusive.
- Have a clinical diagnosis of acne vulgaris, defined as having all of the following:
- On the face, ≥ 20 inflammatory lesions (papules and pustules)
- On the face, ≥ 25 non-inflammatory lesions (open and closed comedones)
- On the face, ≤ 2 nodulocystic lesions (nodules and cysts)
Show all 12Show fewer
- Baseline IGA of acne severity grade 2, 3, or 4
- Be in general good health and free from any clinically significant disease other than acne vulgaris that might interfere with the study evaluations.
- Be willing to refrain from use of all other topical acne medications or antibiotics during the 12-week treatment period.
- Be willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
- Female subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years) must have a negative urine pregnancy test (with a minimum sensitivity of at least 50 mIU/mL for human chorionic gonadotropin [hCG], begin treatment during a normal menstrual period and must agree to use a medically accepted method of contraception during the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to Visit 1/Day 1.
- Be willing to limit sun exposure overall, maintain a reasonably constant exposure, and avoid use of tanning booths or other UV light sources during participation in the study.
Who cannot join
- Females who are pregnant, breast feeding, planning a pregnancy, or who do not agree to use an acceptable form of birth control 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, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- Currently has active cystic acne, acne conglobata, acne fulminans, secondary acne, or severe acne requiring more than topical treatment.
- Currently has facial sunburn.
- Received initial administrations of estrogens or oral contraceptives < 3 months (90 days) prior to baseline (Visit 1/Day 1), or discontinued estrogens or oral contraceptives < 3 months (90 days) prior to baseline. Use of such therapy must remain constant during the study.
- Use of any treatment listing in Table 8.1 more recently than the indicated washout period prior to baseline (Visit 1/Day 1).
- Need or intent to continue to use any treatment listed in Table 8.1 during the current study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altman Dermatology Associates
Arlington Hts., Illinois, 60005
About this study
Official title: A Double-Blind,Randomized,Parallel-Group,Vehicle-Controlled,MulticenterStudy ComparingaGenericTazaroteneCream,0.1%toReference Listed Drug Tazorac® Cream, 0.1% and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris
To compare the safety and efficacy profiles of Tazarotene Cream, 0.1 % to the reference listed drug Tazorac® (tazarotene) Cream, 0.1 % in order to demonstrate bioequivalence, and to demonstrate superiority of the 2 active creams over that of the cream vehicle (placebo) in the treatment of acne vulgaris.
Read the detailed description
This is a randomized, placebo-controlled, parallel-group, multicenter, double-blind study of Tazarotene Cream, 0.1% in subjects with acne vulgaris. Subjects will be assigned in a 1:1:1 ratio to test product, reference product, or cream vehicle. Subjects will be admitted into the study only after written informed consent has been obtained and all of the inclusion and none of the exclusion criteria have been met. Randomized subjects will apply the study medication once daily in the evening for 12 weeks (84 days).
- Conditions
- Acne Vulgaris
- Being tested
- Vehicle, Tazarotene Cream, 0.1 %, Tazorac Cream, 0.1%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VehicleDrug
Also called Placebo
Cream Vehicle (placebo) (G \& W Laboratories, Inc.)- vehicle
Tazarotene Cream, 0.1 %Drug
Also called Active
Tazarotene Cream, 0.1 % (G \& W Laboratories, Inc.) - test product
Tazorac Cream, 0.1%Drug
Also called Reference Listed Drug
Tazorac Cream, 0.1% (Allergan, Inc.) - reference product
| Study group | Role | What they receive |
|---|---|---|
| Tazarotene Cream, 0.1 % | Active comparator | Tazarotene Cream, 0.1 % (G \& W Laboratories, Inc.) - test product Receives: Drug: Tazarotene Cream, 0.1 % |
| Tazorac Cream, 0.1% | Other | Tazorac Cream, 0.1% (Allergan, Inc.) - reference product Receives: Drug: Tazorac Cream, 0.1% |
| Vehicle | Placebo comparator | Cream Vehicle (placebo) (G \& W Laboratories, Inc.)- vehicle Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of equivalence of the test product to the reference product
The primary evaluation of equivalence will be through 2-sided 90% confidence intervals (CIs) about the ratio in mean percent reduction from baseline to Visit 4/Week 12 in the number of inflammatory and non-inflammatory lesions, respectively, of the test product to the reference product. These evaluations are based on a normal distribution adjusted for the effects of treatment group and site.
Measured: Week 12
Evaluation of superiority
The primary evaluation of superiority will be conducted using an analysis of variance (ANOVA) model on the mean percent reduction in inflammatory and non-inflammatory lesions, respectively, with treatment and site as fixed effects. Contrasts will be performed to compare each active treatment with the vehicle cream.
Measured: Week 12
Secondary outcomes (1)
Proportion of subjects with a clinical response of "success"
The secondary efficacy endpoint will include the proportion of subjects with a clinical response of "success" at Visit 4/ Week 12. Success is defined as an Investigator's Global Assessment (IGA) score that is at least 2 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 posted11 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionJul 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,741 participants (actual)
Sponsor and investigators
- Lead sponsor
- G & W Laboratories Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Bukhalo, MD, Principal investigator, Altman Dermatology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160678
- Sponsor's protocol ID
- SYM 2014-01
- Status last verified
- Nov 2016
- First submitted
- 19 Mar 2014
- Last updated
- 3 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind,Randomized,Parallel-Group,Vehicle-Controlled,MulticenterStudy ComparingaGenericTazaroteneCream,0.1%toReference Listed Drug Tazorac® Cream, 0.1% and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02160678
- Acronym / sponsor ID
- SYM 2014-01
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,741 participants (actual)
- Lead sponsor
- G & W Laboratories Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Jun 2014 (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.
To compare the safety and efficacy profiles of Tazarotene Cream, 0.1 % to the reference listed drug Tazorac® (tazarotene) Cream, 0.1 % in order to demonstrate bioequivalence, and to demonstrate superiority of the 2 active creams over that of the cream vehicle (placebo) in the treatment of acne vulgaris.
Detailed description
This is a randomized, placebo-controlled, parallel-group, multicenter, double-blind study of Tazarotene Cream, 0.1% in subjects with acne vulgaris. Subjects will be assigned in a 1:1:1 ratio to test product, reference product, or cream vehicle. Subjects will be admitted into the study only after written informed consent has been obtained and all of the inclusion and none of the exclusion criteria have been met. Randomized subjects will apply the study medication once daily in the evening for 12 weeks (84 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tazarotene Cream, 0.1 % | Active comparator | Drug: Tazarotene Cream, 0.1 %Tazarotene Cream, 0.1 % (G \& W Laboratories, Inc.) - test product |
| Tazorac Cream, 0.1% | Other | Drug: Tazorac Cream, 0.1%Tazorac Cream, 0.1% (Allergan, Inc.) - reference product |
| Vehicle | Placebo comparator | Drug: VehicleCream Vehicle (placebo) (G \& W Laboratories, Inc.)- vehicle |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Be willing and able to provide written informed consent/assent for the study.
- Be a healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years of age, inclusive.
- Have a clinical diagnosis of acne vulgaris, defined as having all of the following:
- Be in general good health and free from any clinically significant disease other than acne vulgaris that might interfere with the study evaluations.
- Be willing to refrain from use of all other topical acne medications or antibiotics during the 12-week treatment period.
Key exclusion criteria (7 listed)
- Females who are pregnant, breast feeding, planning a pregnancy, or who do not agree to use an acceptable form of birth control 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, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- Currently has active cystic acne, acne conglobata, acne fulminans, secondary acne, or severe acne requiring more than topical treatment.
- Currently has facial sunburn.
- Received initial administrations of estrogens or oral contraceptives < 3 months (90 days) prior to baseline (Visit 1/Day 1), or discontinued estrogens or oral contraceptives < 3 months (90 days) prior to baseline. Use of such therapy must remain constant during 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 |
|---|---|---|
| VehicleAlso: PlaceboCream Vehicle (placebo) (G \& W Laboratories, Inc.)- vehicle | Drug | Vehicle |
| Tazarotene Cream, 0.1 %Also: ActiveTazarotene Cream, 0.1 % (G \& W Laboratories, Inc.) - test product | Drug | Tazarotene Cream, 0.1 % |
| Tazorac Cream, 0.1%Also: Reference Listed DrugTazorac Cream, 0.1% (Allergan, Inc.) - reference product | Drug | Tazorac Cream, 0.1% |
Primary outcome
Evaluation of equivalence of the test product to the reference product
Time frame: Week 12
The primary evaluation of equivalence will be through 2-sided 90% confidence intervals (CIs) about the ratio in mean percent reduction from baseline to Visit 4/Week 12 in the number of inflammatory and non-inflammatory lesions, respectively, of the test product to the reference product. These evaluations are based on a normal distribution adjusted for the effects of treatment group and site.
Evaluation of superiority
Time frame: Week 12
The primary evaluation of superiority will be conducted using an analysis of variance (ANOVA) model on the mean percent reduction in inflammatory and non-inflammatory lesions, respectively, with treatment and site as fixed effects. Contrasts will be performed to compare each active treatment with the vehicle cream.
1 secondary outcome
Proportion of subjects with a 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 3 Nov 2016.
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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.
Michael Bukhalo, MD principal investigator
Altman Dermatology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tazarotene Cream, 0.1 % and Tazorac Cream, 0.1% in people with Acne Vulgaris, run by G & W Laboratories Inc. at 1 site 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 12 inclusion and 7 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Evaluation of equivalence of the test product to the reference product (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 3 Nov 2016.