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NCT02004574: TRIANGLE
Investigator Initiated Study for Optimal Maintenance Treatment With Calcipotriol /Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris
Phase 4 trial testing Calcipotriol/betamethasone dipropionate gel in Psoriasis Vulgaris in 201 participants. Completed in 1 June 2014.
1 June 2014
Quick facts
| Lead sponsor | Jooheung Lee |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 201 |
| Start date | 1 October 2013 |
| Primary completion | 1 June 2014 |
| Estimated completion | 1 June 2014 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Calcipotriol/betamethasone dipropionate gel — full drug profile →
Conditions studied
- Psoriasis Vulgaris — all drugs for Psoriasis Vulgaris →
Sponsor
Jooheung Lee — full company profile →
Who can join
19 and older, any sex, with Psoriasis Vulgaris. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of "Responder" (subjects with a grade of "clear" or "almost clear") according to IGA at Week 16
Time frame: Week 16
The primary objective of this study is to evaluate the percentages of "Responder"\* at week 16, as assessed by Investigator's Global Assessment of Disease Severity (IGA), in three different 8-week maintenance regimens of Xamiol® gel after 8-week induction treatment with Xamiol® gel in patients with psoriasis vulgaris.
Sponsor's own description
The combination of calcipotriol and betamethasone dipropionate used in an ointment formulation (Daivobet® ointment) has shown to have an excellent efficacy and safety in the short-term and long-term management of psoriasis vulgaris. A newly developed gel formulation (Xamiol® gel) of calcipotriol and betamethasone dipropionate has recently been approved and marketed in Korea as a topical treatment of moderate to severe scalp psoriasis and non-scalp psoriasis vulgaris. Xamiol® gel, the investigational product (IP) used in this study, prevents keratinization by normalizing the reproduction cycle of skin cells. It also relieves itching associated with psoriasis. Xamiol® gel was initially approved for treatment of moderate to severe scalp psoriasis and its label was extended to non-scalp psoriasis vulgaris in October 2012. Since patient compliance is one of the important factors in achieving effective outcomes in the treatment of psoriasis, the once daily dosing of Xamiol® gel is expected to enhance compliance and treatment outcomes as well as to provide a safe and effective therapeutic option.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02004574
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Psoriasis Vulgaris
Currently open trials in the same condition.
- NCT07426120 — Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III · Phase 3 · recruiting
- NCT07320872 — Correlation Between Vaspin Gene Polymorphism and Serum Vaspin Levels in Psoriasis Vulgaris · recruiting
- NCT06398106 — Proactive TDM Versus Standard Use of Biologics in Psoriasis · Phase 4 · recruiting
- NCT05185258 — Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study · Phase 4 · active not recruiting
- NCT04950218 — Prevalence and Risk Factors asSOciated With CArdiac comorbiDIty in psoriAsis · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02004574 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jooheung Lee
- Last refreshed: 3 June 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02004574.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing