Acne VulgarisPhase 3NCT05550337
Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris
A Phase 3 study testing Trifarotene 0.005 % Topical Cream and AKLIEF® in people with Acne Vulgaris, run by Teva Pharmaceuticals USA at 14 sites in United States.
Trial summary
To compare the safety and efficacy of the test (Trifarotene 0.005% cream), placebo (vehicle cream) and reference AKLIEF® (Trifarotene 0.005% cream) treatments to demonstrate clinical equivalence in subjects with 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?
- Trifarotene 0.005 % Topical Cream and AKLIEF®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 807 participants
- Where
- 14 sitesUnited States
- Study dates
- 19 Sep 2022to 9 May 2023
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or non-pregnant, non-lactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB/IEC approved written informed consent. Subjects 12 to 17 years of age inclusive must have provided IRB/IEC approved written assent; this written assent must be accompanied by an IRB/IEC 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 ≥ 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), at screening/baseline on the face.
- For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. All lesions will be counted, including those present on the nose. Subjects may have acne lesions on other areas of the body which will be excluded from the count and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below) at screening/baseline. Acne vulgaris should be stable (for at least 3 months prior to screening), with minimal variation from day to day and within each day, in the opinion of the subject.
- Table 1: Investigator's Global Assessment (IGA) Scale for Acne Vulgaris Grade Description 0 Clear skin with no inflammatory or non-inflammatory lesions 1 Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion 2 Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3 Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4 Severe; greater than Grade 3; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than a few nodular lesions
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- The eCRF will allow for reporting by Investigators of lesion worsening beyond Grade 4 with treatment. Acne vulgaris subjects with nodulocystic acne are not to be enrolled in the study.
- Subjects who worsen beyond Grade 4 will be described in the safety evaluation. Note: Counts of nodules and cysts will be reported separately and not included in the inflammatory or non-inflammatory lesion counts.
- Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period, other than the investigational product.
- Female subjects of childbearing potential (*WOCBP) must not be pregnant or lactating at the time of screening/baseline visit as documented by a negative urine pregnancy test with a sensitivity to at least 25 mIU/ml hCG .
- Female subjects of childbearing potential (WOCBP) are defined as sexually mature women without prior hysterectomy, or who have had any evidence of menses in the past 12 months.
- However, women who have been amenorrheic for the past 12 or more months are still considered to be of childbearing potential, if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti- estrogens, or ovarian suppression. Postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or women who have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy with surgery at least 4 weeks prior to randomization) are not considered WOCBP. Subjects who have undergone tubal ligation are NOT considered as surgically sterile.
- Female subjects of childbearing potential must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
- For the purposes of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, medroxyprogesterone acetate (ex. Depo-Provera®) with stabilized use for at least 3 months, vaginal contraceptive (ex. etonogestrel/ethinyl estradiol vaginal ring (ex. NuvaRing®), contraceptive implant with etonogestrel or equivalent, double barrier methods, (e.g.
- condom and spermicide), intrauterine device (IUD), true abstinence (if in line with subject's lifestyle).
- If a subject who was abstinent becomes sexually active during the study, a 2nd acceptable method of birth control should be used and documented.
- Subjects on hormonal contraception must be stabilized on the same type for at least three months prior to enrollment in the study and must not change the method during the study.
- A sterile sexual partner is not considered an adequate form of birth control.
- Female subjects who are premenarchal, surgically sterilized (by *hysterectomy or bilateral oophorectomy) or postmenopausal for at least 1 year (defined as women who have been amenorrheic for at least 12 consecutive months, without other known or suspected primary cause).
- All male subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug.
- True abstinence is an acceptable method of birth control if in line with subject's lifestyle.
- Female partners should use an acceptable method of birth control as described in the above criteria 7.
- Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at all required study visits and refraining from the use of all other topical acne medications or antibiotics during the 12-week treatment period.
- Subjects must be in good health and free from any clinically significant disease, which may interfere with the evaluation of acne vulgaris or the administration of the investigative product.
- 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, lactating or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to trifarotene, tretinoin, retinoids, 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 on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid or corticosteroid-induced acne, steroid folliculitis, or bacterial folliculitis, auto-immune disease, perioral dermatitis, carcinoid syndrome, mastocytosis, acneiform eruptions caused by make-up and medication, facial psoriasis and facial eczema).
- Subjects with nodulocystic acne (> 2 nodules and cysts). [Nodules or cysts defined as; deepseated in the skin (i.e., centered in the dermis or subcutis) and an inflammatory lesion greater than or equal to 5 mm in diameter], acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or acne vulgaris requiring systemic treatment.
- Subjects with excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- Subjects with tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's acne.
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- Subjects who have used within 6 months prior to screening/baseline oral retinoids (e.g., Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). These treatments with oral retinoids or Vitamin A supplements are prohibited during the study participation.
- Subjects who have used within 1 month prior to screening/baseline neuromuscular blocking agents or androgen receptor blockers (e.g., spironolactone, Flutamide etc.).
- Subjects who have had laser therapy, electrodessication phototherapy and or cosmetic procedures (e.g., ClearLight ® BOTOX, Filler, micro needling) to the facial area within 6 months prior to study entry.
- Subjects who have had facial cosmetic procedures (e.g., facials) or application of cosmetic products (cosmetics, makeup or facial products that have a strong drying or possible interactive effect, particularly preparations containing spices, lime sulfur, resorcinol, or salicylic acid with tretinoin or other retinoids) which may affect the efficacy and safety profile of the investigational product within 2 weeks prior to study entry.
- Subjects who have received radiation therapy and/or anti-neoplastic agents within 3 months prior to screening/baseline.
- Subjects who have used for less than (<) 3 months prior to screening/baseline estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
- Subjects who have used any of the following procedures on the face within 1 month prior to screening/baseline or use 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 screening/baseline or during the study:
- androgen receptor blockers (e.g., spironolactone, Flutamide etc.)
- systemic steroids,
- systemic antibiotics,
- systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout),
- systemic anti-inflammatory agents. If Subject uses a systemic anti-inflammatory product during the study, the Principal Investigator will judge if this protocol deviation is clinically significant,
- have taken any drugs that lower the immune system.
- topical immunomodulators
- Subjects who have used any of the following treatments within 2 weeks prior to screening/baseline or during the study:
- topical steroids,
- topical retinoids,
- topical acne treatments including over-the-counter preparations
- topical anti-inflammatory agents
- topical antibiotics
- abradants,
- peels containing glycolic or other acids,
- washes or soaps, containing glycolic acid,
- Alpha-hydroxy acids,
- sulfacetamide sodium,
- non-mild facial cleansers, moisturizers that contained retinol
- topical products that contain high amounts of alcohol
- wax depilation of the face
- Use of tanning booths
- The application of alcohol-based toners or any product with high concentrations of alcohol, astringents, medicated topical preparations (prescription and OTC products including those with spices or lime ingredients). or medicated make-up, medicated or harsh soaps, medicated cleansers, and cosmetics that make subject skin dry to the face (products that have a strong drying effect, particularly preparations containing sulfur, resorcinol, or salicylic acid with tretinoin or other retinoids).
- Subjects who have on-going malignancies requiring systemic treatment or who have any malignancy of the skin of the facial area.
- Subjects with active facial sunburn or peeling from sunburn.
- Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold. Exposure to excessive UV radiation within 1 week prior to screening/baseline.
- Subjects who use a sauna within 48 hours prior to screening/baseline.
- Subjects who have unstable medical disorders that are clinically significant or have life threatening diseases, or other medical condition (i.e., chronic infectious disease, system disorder, organ disorder, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, renal disease, severe psychiatric condition, etc.) that, in the Investigator's opinion, would place the study Subject at undue risk by participation or could jeopardize the integrity of the study evaluations.
- 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) within one year prior to screening.
- Subjects, who in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
- Subjects who are unable or unwilling to give informed consent.
- Subjects who are illiterate.
- Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an investigational drug) within 30 days prior to screening/baseline or where sufficient washout period has not been achieved; whichever time period is longer. 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.
- Subjects who live in the same household with subjects who are participating or have been previously enrolled in this study.
- The subject is a member of the investigational study staff or a family member of the investigational study staff.
- Subject having symptoms* of Coronavirus Disease 2019 (COVID-19) within the 10 days prior to screening/baseline/visit 1 or have had close contact with someone with suspected or confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection within 10 days prior to screening/baseline/visit 1 or who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of acquiring SARS-CoV-2 infections.
- Stuffy or runny nose, sore throat, shortness of breath (difficulty breathing), cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, vomiting, diarrhea, loss of sense of taste and smell.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Site 10012
Baton Rouge, Louisiana, 70809
Site 10013
Baton Rouge, Louisiana, 70809
Site 10001
Brandon, Florida, 33511
Site 10009
Dallas, Texas, 75234
Site 10006
El Paso, Texas, 79902
Site 10007
El Paso, Texas, 79925
Site 10003
Fort Lauderdale, Florida, 33308
Site 10008
Las Cruces, New Mexico, 88011
Site 10004
Miami, Florida, 33175
Site 10005
Miramar, Florida, 33027
Site 10011
New Orleans, Louisiana, 70115
Site 10010
Saint Clair, Pennsylvania, 15241
Site 10002
Tampa, Florida, 33609
Site 10011
West Covina, California, 91790
About this study
Official title: A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, THREE-ARM, PLACEBO CONTROLLED, PARALLEL-DESIGN GROUP STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE COMPARING TRIFAROTENE CREAM, 0.005% (TEVA PHARMACEUTICALS, INC. TO AKLIEF ® (TRIFAROTENE 0.005% CREAM) (GALDERMA LABORATORIES, L.P., USA), IN THE TREATMENT OF ACNE VULGARIS
To compare the safety and efficacy of the test (Trifarotene 0.005% cream), placebo (vehicle cream) and reference AKLIEF® (Trifarotene 0.005% cream) treatments to demonstrate clinical equivalence in subjects with acne vulgaris.
Read the detailed description
To compare the safety of Test, Reference, and Placebo treatments in patients with acne vulgaris. Subjects in this randomized, double-blind, three-arm, placebo controlled, parallel-design, multi-site study will be randomly assigned in a 1:1:1 ratio to treatment with the test product, reference product or placebo control, respectively.
- Conditions
- Acne Vulgaris
- Being tested
- Trifarotene 0.005 % Topical Cream, AKLIEF®, 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.
Trifarotene 0.005 % Topical CreamDrug
Cream
AKLIEF®Drug
Also called Trifarotene 0.005 % Topical Cream
Cream
PlaceboDrug
Also called Vehicle of Test Product
Cream
| Study group | Role | What they receive |
|---|---|---|
| Test: Trifarotene Cream, 0.005% | Experimental | Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days. Receives: Drug: Trifarotene 0.005 % Topical Cream |
| AKLIEF® | Active comparator | AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days. Receives: Drug: AKLIEF® |
| Vehicle Product | Placebo comparator | Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Change in Inflammatory Lesion Counts
Mean percent change from screening/baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Measured: Baseline and 12 Weeks
Primary Change in Non-Inflammatory Lesion Count
Mean percent change from screening/baseline to week 12 in the noninflammatory (open and closed comedones) lesion counts.
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start19 Sep 2022
- Primary completion9 May 2023
- Study completion9 May 2023
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550337
- Sponsor's protocol ID
- TRIF-2101
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2022
- Last updated
- 26 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, THREE-ARM, PLACEBO CONTROLLED, PARALLEL-DESIGN GROUP STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE COMPARING TRIFAROTENE CREAM, 0.005% (TEVA PHARMACEUTICALS, INC. TO AKLIEF ® (TRIFAROTENE 0.005% CREAM) (GALDERMA LABORATORIES, L.P., USA), IN THE TREATMENT OF ACNE VULGARIS
- ClinicalTrials.gov ID
- NCT05550337
- Acronym / sponsor ID
- TRIF-2101
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 807 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals, Inc.
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Posted 26 Sep 2024
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 of the test (Trifarotene 0.005% cream), placebo (vehicle cream) and reference AKLIEF® (Trifarotene 0.005% cream) treatments to demonstrate clinical equivalence in subjects with acne vulgaris.
Detailed description
To compare the safety of Test, Reference, and Placebo treatments in patients with acne vulgaris. Subjects in this randomized, double-blind, three-arm, placebo controlled, parallel-design, multi-site study will be randomly assigned in a 1:1:1 ratio to treatment with the test product, reference product or placebo control, respectively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test: Trifarotene Cream, 0.005% | Experimental | Drug: Trifarotene 0.005 % Topical CreamTrifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days. |
| AKLIEF® | Active comparator | Drug: AKLIEF®AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days. |
| Vehicle Product | Placebo comparator | Drug: PlaceboVehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (25 listed)
- Male or non-pregnant, non-lactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB/IEC approved written informed consent. Subjects 12 to 17 years of age inclusive must have provided IRB/IEC approved written assent; this written assent must be accompanied by an IRB/IEC 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 ≥ 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), at screening/baseline on the face.
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below) at screening/baseline. Acne vulgaris should be stable (for at least 3 months prior to screening), with minimal variation from day to day and within each day, in the opinion of the subject.
- Table 1: Investigator's Global Assessment (IGA) Scale for Acne Vulgaris Grade Description 0 Clear skin with no inflammatory or non-inflammatory lesions 1 Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion 2 Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3 Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4 Severe; greater than Grade 3; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than a few nodular lesions
Key exclusion criteria (58 listed)
- Female subjects who are pregnant, lactating or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to trifarotene, tretinoin, retinoids, 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 on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid or corticosteroid-induced acne, steroid folliculitis, or bacterial folliculitis, auto-immune disease, perioral dermatitis, carcinoid syndrome, mastocytosis, acneiform eruptions caused by make-up and medication, facial psoriasis and facial eczema).
- Subjects with nodulocystic acne (> 2 nodules and cysts). [Nodules or cysts defined as; deepseated in the skin (i.e., centered in the dermis or subcutis) and an inflammatory lesion greater than or equal to 5 mm in diameter], acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or acne vulgaris requiring systemic treatment.
- 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 |
|---|---|---|
| Trifarotene 0.005 % Topical CreamCream | Drug | Test: Trifarotene Cream, 0.005% |
| AKLIEF®Also: Trifarotene 0.005 % Topical CreamCream | Drug | AKLIEF® |
| PlaceboAlso: Vehicle of Test ProductCream | Drug | Vehicle Product |
Primary outcome
Primary Change in Inflammatory Lesion Counts
Time frame: Baseline and 12 Weeks
Mean percent change from screening/baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Primary Change in Non-Inflammatory Lesion Count
Time frame: Baseline and 12 Weeks
Mean percent change from screening/baseline to week 12 in the noninflammatory (open and closed comedones) lesion counts.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trifarotene 0.005 % Topical Cream and AKLIEF® in people with Acne Vulgaris, run by Teva Pharmaceuticals USA at 14 sites 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 25 inclusion and 58 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 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Yes. Results are posted in the registry (first posted 26 Sep 2024). 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?
Primary Change in Inflammatory Lesion Counts (time frame: Baseline and 12 Weeks). 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 26 Sep 2024.