Acne VulgarisPhase 1NCT06733402
A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris
A Phase 1 study testing Trifarotene Cream 0.005%, AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG and AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control 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?
- Trifarotene Cream 0.005%, AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG and AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2024to 9 Nov 2024
- 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 must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3 or 4 as per the Investigator's Global Assessment (IGA).
- 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 baseline on the face.
- Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.
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 Trifarotene, retinoids and/or any of the study medication ingredients.
- Subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- Subjects with a baseline irritation score of 3 = severe (marked, intense).
Trial locations and contacts
1 site in 1 country.
United States1 site
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, 10532
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and Each Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris.
To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.
Read the detailed description
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and each active treatment to a placebo control in the treatment of acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Trifarotene Cream 0.005%, AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG, AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT, 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 Cream 0.005%Drug
Also called Test Product
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUGDrug
Also called Reference Product
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCTDrug
Also called Reference Product
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
PlaceboDrug
Also called Vehicle
A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Trifarotene Cream 0.005% | Experimental | A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. Receives: Drug: Trifarotene Cream 0.005% |
| AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG | Active comparator | A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. Receives: Drug: AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG |
| AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT | Active comparator | A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. Receives: Drug: AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT |
| Placebo Control | Placebo comparator | A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product
Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) of the lesion counts.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start20 Jun 2024
- Primary completion20 Jun 2024
- Study completion9 Nov 2024
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
- Triple blind
- Who is masked
- Participant, Care provider, 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
- Natalie Yantovskiy, Study director, Taro Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733402
- Sponsor's protocol ID
- TRFC-2405
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and Each Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT06733402
- Acronym / sponsor ID
- TRFC-2405
- 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
- 20 Jun 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 9 Nov 2024 (actual)
- First posted
- 13 Dec 2024 (actual)
- 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 demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.
Detailed description
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and each active treatment to a placebo control in the treatment of acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trifarotene Cream 0.005% | Experimental | Drug: Trifarotene Cream 0.005%A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. |
| AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG | Active comparator | Drug: AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUGA thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. |
| AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT | Active comparator | Drug: AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCTA thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. |
| Placebo Control | Placebo comparator | Drug: PlaceboA thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. |
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 must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3 or 4 as per the Investigator's Global Assessment (IGA).
- 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 baseline on the face.
- Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.
Key exclusion criteria (4 listed)
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to Trifarotene, retinoids and/or any of the study medication ingredients.
- Subjects with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
- Subjects with a baseline irritation score of 3 = severe (marked, intense).
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 Cream 0.005%Also: Test ProductA thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. | Drug | Trifarotene Cream 0.005% |
| AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUGAlso: Reference ProductA thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. | Drug | AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG |
| AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCTAlso: Reference ProductA thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. | Drug | AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT |
| PlaceboAlso: VehicleA thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime. | Drug | Placebo Control |
Primary outcome
Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product
Time frame: Baseline to Week 12
Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) of the lesion counts.
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 13 Dec 2024.
- 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.
Natalie Yantovskiy study director
Taro Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trifarotene Cream 0.005%, AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG and AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, 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 4 inclusion and 4 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 13 Dec 2024. 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 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?
Demonstrate the therapeutic equivalence, efficacy and safety of the Investigational Product (time frame: Baseline to Week 12). 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 13 Dec 2024.