DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Comp01 Lotion; Drug: DFD01 Spray

• Registration Number: NCT02070965
• Lead Sponsor: Primus Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-25
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Disposition First Submitted: 2015-11-24
• Disposition First Submitted QC: 2015-11-24
• Disposition First Posted: 2015-12-28
• Results First Submitted: 2017-01-23
• Results First Submitted QC: 2017-01-23
• Results First Posted: 2017-03-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
2. Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
3. Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit
4. 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 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 except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
4. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea)
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 at night.
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
Comp01 Lotion	Comp01 Lotion	Comp01 Lotion, bid, 14 days
DFD01 Spray Group 1	DFD01 Spray	DFD01 Spray, bid, 28 days
DFD01 Spray Group 2	DFD01 Spray	DFD01 Spray, bid, 14 days

Primary Outcome Measures

Name	Time	Method
The Number of Subjects With HPA Axis Suppression	Day 15

Trial Locations

Locations (12)

California Dermatology and Clinical Research Institute; 🇺🇸 Encinitas, California, United States

Redwood Dermatology Research; 🇺🇸 Santa Rosa, California, United States

Dermatology Consulting Services; 🇺🇸 High Point, North Carolina, United States

Encino Research Center T. Joseph Raoof MD, Inc.; 🇺🇸 Encino, California, United States

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

Bettencourt Skin Center; 🇺🇸 Henderson, Nevada, United States

Paddington Testing Company, Inc.; 🇺🇸 Philadelphia, Pennsylvania, United States

Suzanne Bruce and Associates, PA The Center for Skin Research Katy/Cinco Ranch; 🇺🇸 Katy, Texas, United States

Tennessee Clinical Research Center; 🇺🇸 Nashville, Tennessee, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

Center for Clinical Studies, LTD. LLP; 🇺🇸 Houston, Texas, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States