Trials / Completed
CompletedNCT04080206
A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis
An Open Label, Comparative Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of 188-0551 Spray Versus Reference Listed Drug (RLD) Applied Every 12 Hours for 2 Weeks in Subjects With Moderate to Severe Plaque Psoriasis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" \[RLD\]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 188-0551 Spray | Applied topically twice daily for two weeks |
| DRUG | RLD | Applied topically twice daily for two weeks |
Timeline
- Start date
- 2020-04-07
- Primary completion
- 2021-01-20
- Completion
- 2021-01-20
- First posted
- 2019-09-06
- Last updated
- 2021-05-10
Locations
8 sites across 3 countries: United States, Georgia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04080206. Inclusion in this directory is not an endorsement.