Acne VulgarisPhase 1NCT06063473
A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris
A Phase 1 study testing Trifarotene Cream 0.005% and AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories) in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream 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?
- Trifarotene Cream 0.005% and AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 762 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 13 Jul 2023
- 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
- Healthy volunteers accepted
- 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 who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent;
- Subjects must have a definite clinical diagnosis of acne vulgaris of 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.
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 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 (e.g., on the face: rosacea, dermatitis, psoriasis,squamous cell carcinoma, eczema, acneiform eruptions caused by medications,steroid acne, steroid folliculitis, or bacterial folliculitis).
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.) and to AKLIEF® Cream (Trifarotene 0.005%,Galderma) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris
Read the detailed description
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 and both active treatments to a placebo control in the treatment of acne vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- Trifarotene Cream 0.005%, Placebo, AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)
- 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
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days
PlaceboDrug
Also called Vehicle
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days
AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)Drug
Also called Reference Product
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Trifarotene Cream 0.005% | Experimental | The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days. Receives: Drug: Trifarotene Cream 0.005% |
| AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories) | Active comparator | The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days. Receives: Drug: AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories) |
| Placebo Control | Placebo comparator | The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration in Therapeutic Equivalence & Safety of the Investigational Product
Percent change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) 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 posted2 Oct 2023
- Study start22 Feb 2023
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 762 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
- NCT06063473
- Sponsor's protocol ID
- TRFC-2208
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 2 Oct 2023
- 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 2 Oct 2023. 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.) and to AKLIEF® Cream (Trifarotene 0.005%,Galderma) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06063473
- Acronym / sponsor ID
- TRFC-2208
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 762 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 2 Oct 2023 (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 therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris
Detailed description
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 and both active treatments to a placebo control in the treatment of acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trifarotene Cream 0.005% | Experimental | Drug: Trifarotene Cream 0.005%The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days. |
| AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories) | Active comparator | Drug: AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days. |
| Placebo Control | Placebo comparator | Drug: PlaceboThe study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- 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 who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent;
- Subjects must have a definite clinical diagnosis of acne vulgaris of 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.
Key exclusion criteria (3 listed)
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
- Subjects with a history of hypersensitivity or allergy to 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 (e.g., on the face: rosacea, dermatitis, psoriasis,squamous cell carcinoma, eczema, acneiform eruptions caused by medications,steroid acne, steroid folliculitis, or bacterial folliculitis).
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 ProductThe study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days | Drug | Trifarotene Cream 0.005% |
| PlaceboAlso: VehicleThe study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days | Drug | Placebo Control |
| AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)Also: Reference ProductThe study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days | Drug | AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories) |
Primary outcome
Demonstration in Therapeutic Equivalence & Safety of the Investigational Product
Time frame: Baseline to Week 12
Percent change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) 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 2 Oct 2023.
- 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% and AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories) 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 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 2 Oct 2023. 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?
Demonstration in Therapeutic Equivalence & 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 2 Oct 2023.