Plaque PsoriasisPhase 1NCT03645499
An Open-Label Study to Assess Safety
A Phase 1 study testing Topical TA-102 A, Topical TA-102 B and Topical TA-102 C in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
An Open-Label study to assess safety Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Topical TA-102 A, Topical TA-102 B and Topical TA-102 C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 7 Jan 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis.
- Definite clinical diagnosis of stable plaque psoriasis for at least 6 months.
- Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of plaque psoriasis.
Who cannot join
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- History of allergy or sensitivity to retinoid, corticosteroids and/or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the Subject or the results of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Catawba Research, LLC
Charlotte, North Carolina, 28217
About this study
Official title: An Open-Label Study to Assess the Efficacy and Potential for Adrenal Suppression Following Maximal Use Treatment With TA-102 Topical Formulations in Subjects With Plaque Psoriasis.
An Open-Label study to assess safety
Read the detailed description
An Open-Label study to assess the efficacy and potential for adrenal suppression following maximal use treatment with TA-102 topical formulations in subjects with Plaque Psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- Topical TA-102 A, Topical TA-102 B, Topical TA-102 C, Topical TA-102 D, Topical TA-102 E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical TA-102 ADrug
applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
Topical TA-102 BDrug
applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
Topical TA-102 CDrug
applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
Topical TA-102 DDrug
applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
Topical TA-102 EDrug
applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Topical TA-102 A | Experimental | A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily Receives: Drug: Topical TA-102 A |
| Topical TA-102 B | Experimental | A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily Receives: Drug: Topical TA-102 B |
| Topical TA-102 C | Experimental | A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily Receives: Drug: Topical TA-102 C |
| Topical TA-102 D | Experimental | A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily Receives: Drug: Topical TA-102 D |
| Topical TA-102 E | Experimental | A thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily Receives: Drug: Topical TA-102 E |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with adrenal suppression
number of participants with adrenal suppression developed during the treatment with the study drug
Measured: 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start4 Apr 2018
- Primary completion24 Oct 2019
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 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
- NCT03645499
- Sponsor's protocol ID
- DSTO 1723
- Status last verified
- Nov 2022
- First submitted
- 21 Aug 2018
- Last updated
- 2 Dec 2022
- 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 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Efficacy and Potential for Adrenal Suppression Following Maximal Use Treatment With TA-102 Topical Formulations in Subjects With Plaque Psoriasis.
- ClinicalTrials.gov ID
- NCT03645499
- Acronym / sponsor ID
- DSTO 1723
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 24 Aug 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.
An Open-Label study to assess safety
Detailed description
An Open-Label study to assess the efficacy and potential for adrenal suppression following maximal use treatment with TA-102 topical formulations in subjects with Plaque Psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Topical TA-102 A | Experimental | Drug: Topical TA-102 AA thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily |
| Topical TA-102 B | Experimental | Drug: Topical TA-102 BA thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily |
| Topical TA-102 C | Experimental | Drug: Topical TA-102 CA thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily |
| Topical TA-102 D | Experimental | Drug: Topical TA-102 DA thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily |
| Topical TA-102 E | Experimental | Drug: Topical TA-102 EA thin layer of the study medication will be applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis.
- Definite clinical diagnosis of stable plaque psoriasis for at least 6 months.
- Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of plaque psoriasis.
Key exclusion criteria (2 listed)
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- History of allergy or sensitivity to retinoid, corticosteroids and/or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the Subject or the results of the study.
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 |
|---|---|---|
| Topical TA-102 Aapplied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks | Drug | Topical TA-102 A |
| Topical TA-102 Bapplied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks | Drug | Topical TA-102 B |
| Topical TA-102 Capplied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks | Drug | Topical TA-102 C |
| Topical TA-102 Dapplied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks | Drug | Topical TA-102 D |
| Topical TA-102 Eapplied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks | Drug | Topical TA-102 E |
Primary outcome
number of participants with adrenal suppression
Time frame: 84 Days
number of participants with adrenal suppression developed during the treatment with the study drug
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 Dec 2022.
- Individual participant dataSharing planned: No
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Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
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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 Topical TA-102 A, Topical TA-102 B and Topical TA-102 C in people with Plaque Psoriasis, 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 2 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 Dec 2022. 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. 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?
number of participants with adrenal suppression (time frame: 84 Days). 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 Dec 2022.