A Phase 2 interventional study of DFD01 Spray and Comp01 Lotion in Plaque Psoriasis, sponsored by Primus Pharmaceuticals. Completed at 12 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Primus Pharmaceuticals · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 75 is close to the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Primus Pharmaceuticals is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DFD01 Spray, bid, 28 days
Drug: DFD01 Spray
Comp01 Lotion, bid, 14 days
Drug: Comp01 Lotion
DFD01 Spray, bid, 14 days
Drug: DFD01 Spray
The Number of Subjects With HPA Axis Suppression
Time frame: Day 15
| Milestone | DFD01 Spray Group 1 | Comp01 Lotion | DFD01 Spray Group 2 |
|---|---|---|---|
| Started | 27 | 23 | 25 |
| Completed | 25 | 21 | 24 |
| Not completed | 2 | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 1 |
| Withdrew: Subject moved | 1 | 0 | 0 |
| Participants | DFD01 Spray Group 1 | Comp01 Lotion | DFD01 Spray Group 2 |
|---|---|---|---|
| The Number of Subjects With HPA Axis Suppression | 0 | 5 | 5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DFD01 Spray Group 1 | — | 0/27 (0%) | 2/27 (7.4%) |
| Comp01 Lotion | — | 0/22 (0%) | 6/22 (27.3%) |
| DFD01 Spray Group 2 | — | 0/25 (0%) | 8/25 (32%) |
| Event | DFD01 Spray Group 1 | Comp01 Lotion | DFD01 Spray Group 2 |
|---|---|---|---|
| HPA Axis SuppressionEndocrine disorders | 0/27 | 5/22 | 5/25 |
| HeadacheNervous system disorders | 0/27 | 0/22 | 2/25 |
| Application Site PruritusGeneral disorders | 2/27 | 1/22 | 1/25 |
One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.
| Age, Continuous(years) | DFD01 Spray Group 1 | Comp01 Lotion | DFD01 Spray Group 2 | Total |
|---|---|---|---|---|
| Mean | 46.8 ± 9.99 | 45.4 ± 11.32 | 47.6 ± 13.71 | 46.7 ± 11.55 |
| Sex: Female, Male(Participants) | DFD01 Spray Group 1 | Comp01 Lotion | DFD01 Spray Group 2 | Total |
|---|---|---|---|---|
| Female | 6 | 6 | 9 | 21 |
| Male | 21 | 16 | 16 | 53 |
| Race (NIH/OMB)(Participants) | DFD01 Spray Group 1 | Comp01 Lotion | DFD01 Spray Group 2 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 | 6 |
| White | 24 | 20 | 20 | 64 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | DFD01 Spray Group 1 | Comp01 Lotion | DFD01 Spray Group 2 | Total |
|---|---|---|---|---|
| United States | 27 | 22 | 25 | 74 |
| Percent Body Surface Area (BSA) involved(Percent BSA affected) | DFD01 Spray Group 1 | Comp01 Lotion | DFD01 Spray Group 2 | Total |
|---|---|---|---|---|
| Mean | 26.5 ± 8.61 | 26.8 ± 6.32 | 29.0 ± 11.04 | 27.4 ± 8.90 |
| Investigator's Global Assessment (IGA)(Participants) | DFD01 Spray Group 1 | Comp01 Lotion | DFD01 Spray Group 2 | Total |
|---|---|---|---|---|
| IGA 3 (Moderate) | 20 | 21 | 22 | 63 |
| IGA 4 (Severe/Very Severe) | 7 | 1 | 3 | 11 |
| Normal Adrenal Corticotropic Hormone (ACTH) test(Participants) | DFD01 Spray Group 1 | Comp01 Lotion | DFD01 Spray Group 2 | Total |
|---|---|---|---|---|
| Count of participants | 27 | 22 | 25 | 74 |
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Primus Pharmaceuticals