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

Phase 3

Terminated

• Conditions: Plaque Psoriasis
• Interventions: Drug: DFD01 Spray

• Registration Number: NCT02527421
• Lead Sponsor: Primus Pharmaceuticals

Brief Summary

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

Detailed Description

To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days or when applied twice daily for 29 days, in adolescent subjects with moderate to severe plaque psoriasis under maximal use conditions.

Study Timeline

• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-18
• Study Start: 2015-08-19
• Study First Posted: 2015-08-19
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30
• Results First Submitted: 2021-09-24
• Results First Submitted QC: 2021-09-24
• Results First Posted: 2021-10-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1. Subjects must weigh at least 55 pounds
2. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
3. Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
4. Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
5. 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.

Exclusion Criteria

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
2. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
3. Have received treatment for any type of cancer within 5 years of the Baseline Visit.
4. 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).
5. 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.
6. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
7. Subjects who have an abnormal sleep schedule or work overnight.
8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DFD01 Spray Group 2	DFD01 Spray	DFD01 spray, twice daily, 29 days
DFD01 Spray Group 1	DFD01 Spray	DFD01 spray, twice daily, 15 days

Primary Outcome Measures

Name	Time	Method
Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later	End of Treatment (day 15 or day 28) with recovery 29 days later	Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test
Participants With HPA Axis Suppression at Day 29	Day 29	Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test

Trial Locations

Locations (8)

Site 102; 🇺🇸 Encino, California, United States

Site 101; 🇺🇸 Houston, Texas, United States

Site 104; 🇺🇸 Irvine, California, United States

Site 107; 🇺🇸 New York, New York, United States

Site 106; 🇺🇸 Arlington, Texas, United States

Site 109; 🇺🇸 Lebanon, New Hampshire, United States

Site 100; 🇺🇸 San Diego, California, United States

Site 105; 🇺🇸 San Antonio, Texas, United States