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Trial record 52 of 275 for:    Betamethasone

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

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ClinicalTrials.gov Identifier: NCT02527421
Recruitment Status : Recruiting
First Posted : August 19, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: DFD01 Spray Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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%
Actual Study Start Date : August 19, 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: DFD01 Spray Group 1
DFD01 spray, twice daily, 15 days
Drug: DFD01 Spray
DFD-01 (betamethasone dipropionate) Spray, 0.05%
Other Name: betamethasone

Experimental: DFD01 Spray Group 2
DFD01 spray, twice daily, 29 days
Drug: DFD01 Spray
DFD-01 (betamethasone dipropionate) Spray, 0.05%
Other Name: betamethasone




Primary Outcome Measures :
  1. Participants with HPA axis suppression at Day15 [ Time Frame: Day 15 ]
    Number of participants with HPA axis suppression at Day15, by measuring the level of cortisol in the blood after ACTH stimulation test

  2. Participants with HPA axis suppression at Day 29 [ Time Frame: 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



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527421


Contacts
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Contact: Carmela Fritz 6093759929 cfritz@promiuspharma.com
Contact: Lauren Williams 609-375-9678 LWilliams@drreddys.com

Locations
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United States, California
Site 102 Recruiting
Encino, California, United States, 91436
Site 104 Recruiting
Irvine, California, United States, 92697-1385
Site 100 Recruiting
San Diego, California, United States, 92123
United States, New Hampshire
Site 109 Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
Site 107 Recruiting
New York, New York, United States, 10155
United States, Texas
Site 106 Recruiting
Arlington, Texas, United States, 76014
Site 101 Recruiting
Houston, Texas, United States, 77030
Site 105 Recruiting
San Antonio, Texas, United States, 78218
Sponsors and Collaborators
Promius Pharma, LLC
Investigators
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Study Director: Srinivas Sidgiddi, MD Dr. Reddy's Laboratories, Inc

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Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT02527421     History of Changes
Other Study ID Numbers: DFD01-CD-013
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents