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

Plaque Psoriasis Clinical Trial

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%

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02527421
• Other study ID #: DFD01-CD-013
• Status: Terminated
• Phase: Phase 3
• Start date: August 19, 2015
• Est. completion date: March 30, 2019

Study information

• Verified date: March 2024
• Source: Primus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• DFD01 Spray
DFD-01 (betamethasone dipropionate) Spray, 0.05%

Locations

Country	Name	City	State
United States	Site 106	Arlington	Texas
United States	Site 102	Encino	California
United States	Site 101	Houston	Texas
United States	Site 104	Irvine	California
United States	Site 109	Lebanon	New Hampshire
United States	Site 107	New York	New York
United States	Site 105	San Antonio	Texas
United States	Site 100	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Primus Pharmaceuticals	Prosoft Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With HPA Axis Suppression at 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	End of Treatment (day 15 or day 28) with recovery 29 days later
Primary	Participants With HPA Axis Suppression at 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	Day 29