Clinical trial NCT02527421: DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis
Official title: A Randomized, Parallel Group, Open-Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Prosoft Clinical
First posted: 2015-08-19
Enrollment: 3
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: Participants With HPA Axis Suppression at Day 29
timeFrame: Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Site 102
state: California
city: Irvine
country: United States
facility: Site 104
state: California
city: San Diego
country: United States
facility: Site 100
state: California
city: Lebanon
country: United States
facility: Site 109
state: New Hampshire
city: New York
country: United States
facility: Site 107
state: New York
city: Arlington
country: United States
facility: Site 106
state: Texas
city: Houston
country: United States
facility: Site 101
state: Texas
city: San Antonio
country: United States
facility: Site 105
state: Texas
Study officials:
affiliation: Dr. Reddy's Laboratories, Inc
name: Srinivas Sidgiddi, MD
role: STUDY_DIRECTOR
References: