Scalp PsoriasisPhase 3NCT03331523
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis
A Phase 3 study testing Calcipotriene/Betamethasone Dipropionate and Taclonex® in people with Scalp Psoriasis, run by Glenmark Pharmaceuticals Ltd. India at 31 sites in United States.
Trial summary
This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical… 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/Betamethasone Dipropionate and Taclonex®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 643 participants
- Where
- 31 sitesUnited States
- Study dates
- 20 Oct 2017to 25 Oct 2018
- Phase
- Phase 3
- 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 subjects aged at least 18 years at Visit 1.
- 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.
- A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3).
- A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion.
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 (e.g., atopic dermatitis, contact dermatitis, tinea capitis).
- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters.
- Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.
- History of psoriasis unresponsive to topical treatments.
- Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Investigational Site 6
Ann Arbor, Michigan, 48103
Investigational Site 5
Austin, Texas, 78759
Investigational Site 11
College Station, Texas, 77845
Investigational Site 14
Denver, Colorado, 80220
Investigational Site 24
Encinitas, California, 92024
Investigational Site 29
Forest Hills, New York, 11375
Investigational Site 18
Fountain Inn, South Carolina, 29644
Investigational Site 3
Fremont, California, 94538
Investigational Site 12
Fridley, Minnesota, 55432
Investigational Site 17
Henderson, Nevada, 89052
Investigational Site 4
High Point, North Carolina, 27262
Investigational Site 9
Knoxville, Tennessee, 37922
Investigational Site 25
Las Vegas, Nevada, 89128
Investigational Site 21
Louisville, Kentucky, 40241
Investigational Site 1
Miami, Florida, 33144
Investigational Site 30
Miami, Florida, 33175
Investigational Site 7
Miramar, Florida, 33027
Investigational Site 27
Mt. Pleasant, South Carolina, 29464
Investigational Site 8
Nashville, Tennessee, 37215
Investigational Site 15
New Albany, Indiana, 47150
Investigational Site 31
Norfolk, Virginia, 23507
Investigational Site 23
Richmond, Virginia, 23294
Investigational Site 28
Rochester, New York, 14623
Investigational Site 26
Saint Joseph, Missouri, 64506
Investigational Site 16
San Antonio, Texas, 78213
Investigational Site 19
San Antonio, Texas, 78249
Investigational Site 13
San Diego, California, 92108
Investigational Site 20
San Diego, California, 92123
Investigational Site 32
Santa Monica, California, 90404
Investigational Site 10
South Bend, Indiana, 46617
Investigational Site 22
Tampa, Florida, 33609
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Taclonex® Topical Suspension (LEO Pharma Inc.) in the Treatment of Scalp Psoriasis
This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.
- Conditions
- Scalp Psoriasis
- Being tested
- Calcipotriene/Betamethasone Dipropionate, Taclonex®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriene/Betamethasone DipropionateDrug
Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)
Taclonex®Drug
Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)
PlaceboDrug
Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)
| Study group | Role | What they receive |
|---|---|---|
| Calcipotriene/betamethasone dipropionate | Experimental | Not described Receives: Drug: Calcipotriene/Betamethasone Dipropionate |
| Taclonex® | Active comparator | Not described Receives: Drug: Taclonex® |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.
Measured: Day 29
Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start20 Oct 2017
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Todd Kays, Study director, Glenmark Pharmaceuticals Inc., USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331523
- Sponsor's protocol ID
- GLK-1701
- Status last verified
- Dec 2018
- First submitted
- 1 Nov 2017
- Last updated
- 21 Dec 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 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Taclonex® Topical Suspension (LEO Pharma Inc.) in the Treatment of Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT03331523
- Acronym / sponsor ID
- GLK-1701
- Conditions
- Scalp Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 6 Nov 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 is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcipotriene/betamethasone dipropionate | Experimental | Drug: Calcipotriene/Betamethasone Dipropionate |
| Taclonex® | Active comparator | Drug: Taclonex® |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.
- 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.
- A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3).
- A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion.
Key exclusion criteria (6 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 (e.g., atopic dermatitis, contact dermatitis, tinea capitis).
- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters.
- Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.
- History of psoriasis unresponsive to topical treatments.
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/Betamethasone DipropionateTopical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) | Drug | Calcipotriene/betamethasone dipropionate |
| Taclonex®Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.) | Drug | Taclonex® |
| PlaceboPlacebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.) | Drug | Placebo |
Primary outcome
Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.
Time frame: Day 29
Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.
Time frame: Day 29
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 21 Dec 2018.
- 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.
William Todd Kays study director
Glenmark Pharmaceuticals Inc., USA
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcipotriene/Betamethasone Dipropionate and Taclonex® in people with Scalp Psoriasis, run by Glenmark Pharmaceuticals Ltd. India at 31 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 4 inclusion and 6 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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit. (time frame: Day 29). The study lists 2 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 21 Dec 2018.