Scalp PsoriasisPhase 1NCT03122353
BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis
A Phase 1 study testing Calcipotriene and betamethasone suspension and Taclonex in people with Scalp Psoriasis, run by Tolmar Inc. at 34 sites in United States.
Trial summary
This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- Calcipotriene and betamethasone suspension and Taclonex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 699 participants
- Where
- 34 sitesUnited States
- Study dates
- 11 Apr 2017to 15 Nov 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-lactating female, at least 18 years of age.
- Female subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized or postmenopausal for at least 2 years).
- A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
- Scalp psoriasis consistent with at least moderate disease severity (grade ≥ 3) using the Physician's Global Assessment (PGA) of disease severity.
- Plaque elevation of at least moderate severity (grade ≥ 3) at the scalp target lesion site using the Psoriasis Area Severity Index (PASI). The most severe lesion at Baseline will be identified as the scalp target lesion.
- Agree to stop use of all other topical or systemic antipsoriatic treatments, corticosteroids, immunosuppressive drugs, calcium supplements and Vitamin D supplements or Vitamin D analogs at a dose > 400 IU/day during the study.
- Currently in general good health and free from any clinically significant disease, other than scalp psoriasis and psoriasis vulgaris, that may interfere with the study evaluations.
- Willing and able to understand and comply with the requirements of the study, apply IP as instructed, attend required study visits, comply with study prohibitions, and be able to complete the study.
Who cannot join
- Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
- Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (eg, atopic dermatitis, contact dermatitis, tinea capitis).
- History of hypersensitivity to any component of TEST or RLD.
- Current or past history of hypercalcemia, hypercalciuria, vitamin D toxicity, severe renal insufficiency, or hepatic disorders.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Site 07
Anderson, South Carolina, 29621
Site 21
Austin, Texas, 78759
Site 20
Boca Raton, Florida, 33486
Site 01
Brandon, Florida, 33511
Site 25
Coral Gables, Florida, 33134
Site 06
Dallas, Texas, 75234
Site 34
Denver, Colorado, 80220
Site 30
El Paso, Texas, 79902
Site 29
Fremont, California, 94538
Site 28
Hazleton, Pennsylvania, 18201
Site 11
Hialeah, Florida, 33012
Site 09
High Point, North Carolina, 27262
Site 17
Hot Springs, Arkansas, 71913
Site 32
Johnston, Rhode Island, 02919
Site 33
Lake Charles, Louisiana, 70601
Site 14
Las Vegas, Nevada, 89106
Site 12
Los Angeles, California, 90036
Site 26
Miami, Florida, 33126
Site 04
Miami, Florida, 33175
Site 05
Miramar, Florida, 33027
Site 35
Mt. Pleasant, South Carolina, 29464
Site 08
Murphy, Texas, 75094
Site 22
Norfolk, Virginia, 23507
Site 19
Olathe, Kansas, 66061
Site 16
Plainfield, Indiana, 46168
Site 27
Saint Joseph, Missouri, 64506
Site 10
Salt Lake City, Utah, 84117
Site 15
San Antonio, Texas, 78229
Site 31
San Antonio, Texas, 78229
Site 18
Sherman Oaks, California, 91403
Site 02
Tampa, Florida, 33609
Site 03
Tampa, Florida, 33618
Site 24
Upper Saint Clair, Pennsylvania, 15241
Site 23
Winter Park, Florida, 32792
About this study
Official title: A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis
This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.
Read the detailed description
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.
- Conditions
- Scalp Psoriasis
- Being tested
- Calcipotriene and betamethasone suspension, Taclonex, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriene and betamethasone suspensionDrug
Also called Calcipotriene, betamethasone
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
TaclonexDrug
Also called Calcipotriene, betamethasone
Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
PlaceboDrug
Also called Vehicle
vehicle used as placebo
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriene Hydrate and Betamethasone | Experimental | Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% Receives: Drug: Calcipotriene and betamethasone suspension |
| Taclonex | Active comparator | Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% Receives: Drug: Taclonex |
| Placebo | Placebo comparator | Topical suspension without active ingredient Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area Severity Index (PASI)
To evaluate the change in clinical outcome of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis. From baseline to end of study.
Measured: at Day 1, Day 28
Physician Global Assessment (PGA)
To evaluate the change in global severity of skin of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex, and Vehicle for scalp psoriasis. From baseline to end of study.
Measured: at Day 1, Day 28
Body Surface Area (BSA)
To evaluate the total body area of skin affected by psoriasis.
Measured: at Day 1
Adverse Events and Serious Adverse Events
Risk for adverse events and serious adverse events for exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis
Measured: at Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start11 Apr 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tolmar Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Joffrion, Study director, Catawba Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122353
- Sponsor's protocol ID
- TOL2708C
- Status last verified
- Mar 2018
- First submitted
- 6 Apr 2017
- Last updated
- 7 Mar 2018
- 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 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT03122353
- Acronym / sponsor ID
- TOL2708C
- Conditions
- Scalp Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 699 participants (actual)
- Lead sponsor
- Tolmar Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 20 Apr 2017 (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.
This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.
Detailed description
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcipotriene Hydrate and Betamethasone | Experimental | Drug: Calcipotriene and betamethasone suspensionCalcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% |
| Taclonex | Active comparator | Drug: TaclonexCalcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% |
| Placebo | Placebo comparator | Drug: PlaceboTopical suspension without active ingredient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or non-pregnant, non-lactating female, at least 18 years of age.
- Female subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized or postmenopausal for at least 2 years).
- A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
- Scalp psoriasis consistent with at least moderate disease severity (grade ≥ 3) using the Physician's Global Assessment (PGA) of disease severity.
- Plaque elevation of at least moderate severity (grade ≥ 3) at the scalp target lesion site using the Psoriasis Area Severity Index (PASI). The most severe lesion at Baseline will be identified as the scalp target lesion.
Key exclusion criteria (4 listed)
- Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
- Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (eg, atopic dermatitis, contact dermatitis, tinea capitis).
- History of hypersensitivity to any component of TEST or RLD.
- Current or past history of hypercalcemia, hypercalciuria, vitamin D toxicity, severe renal insufficiency, or hepatic disorders.
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 |
|---|---|---|
| Calcipotriene and betamethasone suspensionAlso: Calcipotriene, betamethasoneCalcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% | Drug | Calcipotriene Hydrate and Betamethasone |
| TaclonexAlso: Calcipotriene, betamethasoneCalcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% | Drug | Taclonex |
| PlaceboAlso: Vehiclevehicle used as placebo | Drug | Placebo |
Primary outcome
Psoriasis Area Severity Index (PASI)
Time frame: at Day 1, Day 28
To evaluate the change in clinical outcome of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis. From baseline to end of study.
Physician Global Assessment (PGA)
Time frame: at Day 1, Day 28
To evaluate the change in global severity of skin of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex, and Vehicle for scalp psoriasis. From baseline to end of study.
Body Surface Area (BSA)
Time frame: at Day 1
To evaluate the total body area of skin affected by psoriasis.
Adverse Events and Serious Adverse Events
Time frame: at Day 28
Risk for adverse events and serious adverse events for exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis
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 7 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Scalp Psoriasis
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Plaque Psoriasis
RecruitingPhase 4
Immune Spatial Features of Guselkumab Cutaneous Response
Psoriasis of Scalp
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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.
Jim Joffrion study director
Catawba Research
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcipotriene and betamethasone suspension and Taclonex in people with Scalp Psoriasis, run by Tolmar Inc. at 34 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 8 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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 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?
Psoriasis Area Severity Index (PASI) (time frame: at Day 1, Day 28). The study lists 4 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 7 Mar 2018.