Acne VulgarisEarly Phase 1NCT03427554
To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris
A Early Phase 1 study testing Tretinoin cream 0.1% and RETIN-A® Cream in people with Acne Vulgaris, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®. 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?
- Tretinoin cream 0.1% and RETIN-A® Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 455 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 26 Jan 2018
- Phase
- Early 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 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 be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
Who cannot join
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Catawba Research, LLC
Charlotte, North Carolina, 28217
About this study
Official title: A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.
Read the detailed description
A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- Tretinoin cream 0.1%, RETIN-A® Cream, Vehicle of the test product
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tretinoin cream 0.1%Drug
Also called Tretinoin
Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
RETIN-A® CreamDrug
Also called Tretinoin
RETIN-A® (Tretinoin) Cream (Valeant)
Vehicle of the test productDrug
Also called Placebo
Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
| Study group | Role | What they receive |
|---|---|---|
| Tretinoin cream 0.1% | Experimental | Once daily at home, to apply the entire affected areas of the face. Receives: Drug: Tretinoin cream 0.1% |
| RETIN-A® Cream | Active comparator | Once daily at home, to apply the entire affected areas of the face. Receives: Drug: RETIN-A® Cream |
| Vehicle of the test product | Placebo comparator | Once daily at home, to apply the entire affected areas of the face. Receives: Drug: Vehicle of the test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of Bioequivalence
Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start21 Aug 2017
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zaidoon A Al-Zubaidy, Study director, Catawba Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427554
- Sponsor's protocol ID
- TRTC 1622
- Status last verified
- May 2018
- First submitted
- 29 Jan 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. 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 TRETINOIN CREAM, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03427554
- Acronym / sponsor ID
- TRTC 1622
- Conditions
- Acne Vulgaris
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 9 Feb 2018 (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.
Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.
Detailed description
A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) 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 |
|---|---|---|
| Tretinoin cream 0.1% | Experimental | Drug: Tretinoin cream 0.1%Once daily at home, to apply the entire affected areas of the face. |
| RETIN-A® Cream | Active comparator | Drug: RETIN-A® CreamOnce daily at home, to apply the entire affected areas of the face. |
| Vehicle of the test product | Placebo comparator | Drug: Vehicle of the test productOnce daily at home, to apply the entire affected areas of the face. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 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 be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
Key exclusion criteria (1 listed)
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
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 |
|---|---|---|
| Tretinoin cream 0.1%Also: TretinoinTretinoin cream 0.1% (Taro Pharmaceuticals Inc.) | Drug | Tretinoin cream 0.1% |
| RETIN-A® CreamAlso: TretinoinRETIN-A® (Tretinoin) Cream (Valeant) | Drug | RETIN-A® Cream |
| Vehicle of the test productAlso: PlaceboVehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.) | Drug | Vehicle of the test product |
Primary outcome
Demonstration of Bioequivalence
Time frame: 12 weeks
Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory 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 18 May 2018.
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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.
Zaidoon A Al-Zubaidy study director
Catawba Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tretinoin cream 0.1% and RETIN-A® Cream 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 3 inclusion and 1 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 18 May 2018. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 of Bioequivalence (time frame: 12 weeks). 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 18 May 2018.