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NCT02368210
A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)
Phase 3 trial testing 122-0551 Foam in Plaque Psoriasis in 151 participants. Completed in 1 February 2017.
1 June 2015
Quick facts
| Lead sponsor | Therapeutics, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 151 |
| Start date | 1 January 2015 |
| Primary completion | 1 June 2015 |
| Estimated completion | 1 February 2017 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- 122-0551 Foam — full drug profile →
- Vehicle Foam — full drug profile →
Conditions studied
- Plaque Psoriasis — all drugs for Plaque Psoriasis →
Sponsor
Therapeutics, Inc. — full company profile →
Who can join
18 and older, any sex, with Plaque Psoriasis. 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 Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
Time frame: Day 15
The IGA score is a static evaluation of the overall or "average" degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (
Sponsor's own description
This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis
Bhatia N, Stein Gold L, Kircik LH, Schreiber R. · · 2019 · cited 2× · PMID 31424709
Verify or expand the search:
- PubMed search for NCT02368210
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Plaque Psoriasis
Currently open trials in the same condition.
- NCT07357831 — A Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and Vehicle In Plaque Psor · Phase 3 · recruiting
- NCT07250802 — A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis · Phase 3 · recruiting
- NCT06979453 — A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants Wit · Phase 3 · recruiting
- NCT07234591 — A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis · NA · recruiting
- NCT07116967 — Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) · Phase 3 · recruiting
Other Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT05363449 — Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis · Phase 1 · completed
- NCT04080206 — A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis · Phase 2 · completed
- NCT04243486 — A Study of the Safety and Efficacy of UHE-105 Shampoo in Subjects With Scalp Psoriasis · Phase 2 · completed
- NCT03897257 — A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis · Phase 2 · completed
- NCT03759197 — A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis · Phase 3 · completed
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 NCT02368210 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Therapeutics, Inc.
- Last refreshed: 24 October 2018
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/NCT02368210.
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