Acne VulgarisPhase 3NCT02267746
A Study To Evaluate The Safety And Therapeutic Equivalence of Tazarotene Foam 0.1% in Subjects With Acne Vulgaris
A Phase 3 study testing Tazarotene (Fabior™) and Tazarotene (Actavis) in people with Acne Vulgaris, run by Actavis Inc. at 15 sites in 2 countries.
Trial summary
The purpose of this study is to compare the safety and therapeutic equivalence of a generic tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the treatment of acne vulgaris. 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 (Fabior™) and Tazarotene (Actavis)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 893 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Jun 2014to Sep 2014
- 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
- 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.
- Informed Consent/Assent: Subjects ages 12 to 17 years inclusive 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 HIPAA authorization.
- Subjects must have a minimum ≥ 30 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 25 inflammatory lesions (i.e., papules and pustules) AND no cystic lesions and only up to 1 facial nodular lesion (less than or equal to 5 mm) on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e. the lines around the nostrils and under the nostrils) and all mucus membranes. Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
- Subjects must have a severity grade 3, or 4 as per the Investigator's Global Assessment (IGA) (Section 6.2).
- Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period for acne vulgaris, other than the Investigational Product.
- Female Subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), must have a negative urine pregnancy test (with sensitivity down to at least 50mIU/ml hCG) within 2 weeks prior to baseline.
Show all 11Show fewer
- Female Subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), must be willing to use an acceptable form of birth control from the day of the first dose administration.. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months); NuvaRing® (vaginal contraceptive); Implanon™ (contraceptive implant) double barrier methods (e.g. condom and spermicide); IUD, or abstinence with a 2nd acceptable method of birth control should the Subject become sexually active. A sterile sexual partner is NOT considered an adequate form of birth control.
- All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration. Abstinence is an acceptable method of birth control for males.
- Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
- 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
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to tazarotene and its excipients, and/or any of the study medication ingredients.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris. Such conditions include, but are not limited to the following: auto immune disease, rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneform eruptions caused by make-up, medication, facial psoriasis and facial eczema, squamous cell carcinoma, steroid folliculitis, or bacterial folliculitis).
- Subjects who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
- Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- Subjects who have used any of the following within 6 months prior to baseline or use during the study:
Show all 40Show fewer
- oral retinoids (e.g. Accutane®)
- therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
- Subjects who use androgen receptor blockers (such as spironolactone or flutamide) will be excluded from study participation.
- Subjects who have had cosmetic procedures (e.g., facials, wax depilation) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry. Cosmetic procedures and facials are prohibited throughout the study.
- Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline.
- Subjects who have had laser therapy, electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 180 days prior to study entry.
- Subjects who have used any of the following procedures on the face within 1 month prior to baseline or during the study:
- cryodestruction or chemodestruction,
- dermabrasion,
- photodynamic therapy,
- acne surgery,
- intralesional steroids, or
- X-ray therapy.
- Subjects who have used any of the following treatments within 1 month prior to baseline or during the study:
- systemic corticosteroids (including intranasal and inhaled corticosteroids)
- systemic antibiotics,
- systemic treatment for acne vulgaris (other than oral retinoids which need a 6-month washout), or
- systemic anti-inflammatory agents.
- Subjects who have used any of the following treatments within 14 days prior to baseline or during the study:
- topical steroids,
- topical retinoids including over-the-counter preparations,
- α-hydroxy/glycolic acid
- topical anti-inflammatory agents, or
- topical antibiotics.
- Subjects who have started hormonal therapy or changed the dosage of their hormonal therapy within 3 months prior to baseline will be excluded from study participation. The dosage and frequency of use of any hormonal therapy started greater than 3 months prior to baseline must remain unchanged throughout the study (Visit 1 through Visit 4). Hormonal treatments include, but are not limited to, estrogenic and progestational agents such as birth control pills.
- Subjects who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation.
- Subjects with current facial sunburn at baseline or subjects who will have excessive use of tanning booths, sunbathing, or excessive exposure to the sun during the study.
- Subjects who will engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
- 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.
- Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to cannabinoids, cocaine and barbiturates).
- 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 participated in an investigational drug study (i.e., Subjects have been treated with an Investigational Drug) within 30 days 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.
- Subjects who have been previously enrolled in this study.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
Moore Clinical Research
Brandon, Florida, 33511
Research Across America
Dallas, Texas, 75234
Study site
Encino, California, 91436
Center for Dermatology Clinical Research
Fremont, California, 94538
LCC Medical Research Institute
Miami, Florida, 33126
International Dermatology Research
Miami, Florida, 33144
FXM Research Corp
Miami, Florida, 33175
FXM Research Miramar
Miramar, Florida, 33027
Research Across America
Plano, Texas, 75093
Dermatology Research Center
Salt Lake City, Utah, 84117
Moore Clinical Research
Tampa, Florida, 33609
Moore Clinical Research
Tampa, Florida, 33618
Omega Medical Research
Warwick, Rhode Island, 02886
Atlantic Clinical Research Collaborative
Wellington, Florida, 33414
Belize1 site
FXM International
Belize City
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Safety and Therapeutic Equivalence of a Generic Tazarotene Foam 0.1%(Actavis) and the Reference Listed Fabior™(Tazarotene Foam, 0.1%) (Stiefel Laboratories, Inc.) in Treatment of Subjects With Acne Vulgaris
The purpose of this study is to compare the safety and therapeutic equivalence of a generic tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the treatment of acne vulgaris.
Read the detailed description
Although topical retinoids have been individually used to successfully treat acne vulgaris, Fabior™ (Tazarotene) Foam, 0.1% is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis has developed a generic formulation of Tazarotene Foam, 0.1%, and the current study is designed to evaluate the safety and efficacy of this formulation.
- Conditions
- Acne Vulgaris
- Being tested
- Tazarotene (Fabior™), Tazarotene (Actavis), Vehicle foam
- 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 (Fabior™)Drug
Tazarotene (Actavis)Drug
Vehicle foamDrug
| Study group | Role | What they receive |
|---|---|---|
| Fabior™(tazarotene) | Active comparator | Reference listed drug: Fabior™ 0.1% foam (Stiefel) Receives: Drug: Tazarotene (Fabior™) |
| Tazarotene | Experimental | Tazarotene 0/1% foam (Actavis) Receives: Drug: Tazarotene (Actavis) |
| Vehicle foam | Placebo comparator | Foam vehicle of the test product (Actavis) Receives: Drug: Vehicle foam |
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
For the purposes of study treatment and evaluation, these lesions were limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e., the lines around the nostrils and under the nostrils) and all mucus membranes.
Measured: Mean percent change from baseline to Week 12
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts
Estimates of mean percent change from baseline for non-inflammatory lesions for the Test and Reference treatment.
Measured: Mean percent change from baseline to Week 12
Secondary outcomes (1)
The Proportion of Subjects With an IGA Score That is at Least 2 Grades Less Than the Baseline Assessment
Measured: IGA score at Week 12 compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 893 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keri Winkler, Study director, Akesis, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267746
- Sponsor's protocol ID
- WAT 14-1096
- Status last verified
- May 2020
- First submitted
- 14 Oct 2014
- Last updated
- 12 Jun 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 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Safety and Therapeutic Equivalence of a Generic Tazarotene Foam 0.1%(Actavis) and the Reference Listed Fabior™(Tazarotene Foam, 0.1%) (Stiefel Laboratories, Inc.) in Treatment of Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02267746
- Acronym / sponsor ID
- WAT 14-1096
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 893 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Posted 11 May 2020
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 compare the safety and therapeutic equivalence of a generic tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the treatment of acne vulgaris.
Detailed description
Although topical retinoids have been individually used to successfully treat acne vulgaris, Fabior™ (Tazarotene) Foam, 0.1% is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis has developed a generic formulation of Tazarotene Foam, 0.1%, and the current study is designed to evaluate the safety and efficacy of this formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fabior™(tazarotene) | Active comparator | Drug: Tazarotene (Fabior™)Reference listed drug: Fabior™ 0.1% foam (Stiefel) |
| Tazarotene | Experimental | Drug: Tazarotene (Actavis)Tazarotene 0/1% foam (Actavis) |
| Vehicle foam | Placebo comparator | Drug: Vehicle foamFoam vehicle of the test product (Actavis) |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Healthy male or nonpregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Informed Consent/Assent: Subjects ages 12 to 17 years inclusive 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 HIPAA authorization.
- Subjects must have a minimum ≥ 30 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 25 inflammatory lesions (i.e., papules and pustules) AND no cystic lesions and only up to 1 facial nodular lesion (less than or equal to 5 mm) on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e. the lines around the nostrils and under the nostrils) and all mucus membranes. Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
- Subjects must have a severity grade 3, or 4 as per the Investigator's Global Assessment (IGA) (Section 6.2).
- Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period for acne vulgaris, other than the Investigational Product.
Key exclusion criteria (40 listed)
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to tazarotene and its excipients, and/or any of the study medication ingredients.
- Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris. Such conditions include, but are not limited to the following: auto immune disease, rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneform eruptions caused by make-up, medication, facial psoriasis and facial eczema, squamous cell carcinoma, steroid folliculitis, or bacterial folliculitis).
- Subjects who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
- Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with 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 (Fabior™) | Drug | Fabior™(tazarotene) |
| Tazarotene (Actavis) | Drug | Tazarotene |
| Vehicle foam | Drug | Vehicle foam |
Primary outcome
Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts
Time frame: Mean percent change from baseline to Week 12
For the purposes of study treatment and evaluation, these lesions were limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e., the lines around the nostrils and under the nostrils) and all mucus membranes.
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts
Time frame: Mean percent change from baseline to Week 12
Estimates of mean percent change from baseline for non-inflammatory lesions for the Test and Reference treatment.
1 secondary outcome
The Proportion of Subjects With an IGA Score That is at Least 2 Grades Less Than the Baseline Assessment
Time frame: IGA score at Week 12 compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Keri Winkler study director
Akesis, LLC
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tazarotene (Fabior™) and Tazarotene (Actavis) in people with Acne Vulgaris, run by Actavis Inc. at 15 sites in 2 countries.
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 11 inclusion and 40 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Belize. 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 11 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: Mean percent change from baseline to 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 12 Jun 2020.