TerminatedPhase 3

DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis

Stopped: Not able to recruit patients with the current enrollment criteria.

United States3 participantsStarted 2015-08-19

Plain-language summary

To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Age range12 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects must weigh at least 55 pounds
✓. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
✓. Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
✓. Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
✓. Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level \>18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA axis function or adrenal response.

✕. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
✕. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
✕. Have received treatment for any type of cancer within 5 years of the Baseline Visit.
✕. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
✕. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.

Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later

Timeframe: End of Treatment (day 15 or day 28) with recovery 29 days later

Participants With HPA Axis Suppression at Day 29

Timeframe: Day 29

NCT IDNCT02527421

SponsorPrimus Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03-30

Results submitted2021-09-24

Who can participate

Age range12 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects must weigh at least 55 pounds
✓. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
✓. Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
✓. Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
✓. Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level \>18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA axis function or adrenal response.

✕. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
✕. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
✕. Have received treatment for any type of cancer within 5 years of the Baseline Visit.
✕. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
✕. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.