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Patient Satisfaction Following Twice Daily Dosing With DFD-01 in Subjects With Moderate Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02749799
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

Brief Summary:
The purpose of this study is to assess patient satisfaction when DFD-01 is used topically twice a day for moderate plaque psoriasis.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: DFD-01 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: DFD-01 Drug: DFD-01



Primary Outcome Measures :
  1. Change in Total Sign Score from baseline to Day 14. [ Time Frame: From Baseline to Day 14 ]
  2. Treatment Satisfaction Questionnaire for Medication - version II will be administered at Day 14 [ Time Frame: From Baseline to day 14. ]
  3. Change in Clinical response in Investigator's Global Assessment from baseline to Day 14. [ Time Frame: From Baseline to Day 14. ]
  4. Change in % of body surface area from baseline to Day 14. [ Time Frame: Change from Baseline to Day 14. ]
  5. Change in Dermatology Life Quality from baseline to Day 14. [ Time Frame: Change from Baseline to Day 14. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient understands the study procedures and agrees to participate by giving written informed consent. Patients must be willing to authorize use and disclosure of protected health information collected for the study.
  2. Patient must be at least 18 years of age.
  3. Patient must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
  4. At least 3% Body Surface Area involved, not including the face, scalp, groin, axillae and other intertriginous areas.
  5. Female patients of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the patient become sexually active. A female is considered of childbearing potential unless she is:

    1. Postmenopausal for at least 12 months prior to study product administration;
    2. Without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal ligation) for at least 6 months prior to study product administration.

    Reliable methods of contraception are:

    1. Hormonal methods or intrauterine device in use > 90 days prior to study product administration; or
    2. Barrier methods plus spermicide in use at least 14 days prior to study product administration.
    3. Partner has had a vasectomy at least 3 months previous to study product administration.
    4. Essure® that has been in place for at least 3 months before the screening visit with radiograph confirmation of fallopian tube blockage.

    Exception: Sexually inactive female patients of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study. An abstinent female must agree that if she becomes sexually active during the study she will use an acceptable form of contraception.

    All women must complete a urine pregnancy test at the Baseline Visit (Day 1) and the test result must be negative to be eligible for enrollment.

  6. Patient must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (temperature, blood pressure and pulse).
  7. Patient is physically able to apply study product to all affected areas or can obtain help.

Exclusion Criteria:

  1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
  2. Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
  3. Presence of pigmentation, extensive scarring, pigmented lesions, tattoos or sunburn that could interfere with the rating of efficacy parameters.
  4. History of psoriasis unresponsive to topical treatments.
  5. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
  6. Ongoing infection (including viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds) or evidence of chronic infectious disease, history of or current system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation in the study.
  7. Use within 180 days before Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
  8. Have received treatment for any type of cancer within 5 years of the Baseline Visit, except skin cancer and cervical cancer (in situ) that are allowed if at least 1 year before the Baseline Visit.
  9. Use within 60 days before the Baseline Visit of: 1) systemic or topical immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).
  10. Use within 30 days before the Baseline Visit of: 1) systemic corticosteroids, 2) Ultraviolet light therapy, or 3) systemic anti-inflammatory agents* (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine). * Over-the-counter strength non-steroidal anti-inflammatory drugs used for transitional and common aches are permitted during the study.
  11. Use within 14 days before the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.
  12. History of unresolved or current hypothalamic-pituitary-adrenal suppression or significant endocrine disorder (Cushing's disease or Addison's disease) or uncontrolled diabetes.
  13. Patients who have participated in a study of an investigational drug 30 days before the Baseline Visit.
  14. Patients unable to comply with study requirements.
  15. Female patients who are pregnant (or planning to become pregnant) or breast-feeding.
  16. History of drug or alcohol abuse within the last year.
  17. Planned use of a tanning bed during the study.

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): NCT02749799


Locations
United States, Illinois
Site Four
Chicago, Illinois, United States
United States, Indiana
Site Two
New Albany, Indiana, United States
United States, Kentucky
Site One
Louisville, Kentucky, United States, 40202
United States, Nevada
Site Three
Las Vegas, Nevada, United States
Sponsors and Collaborators
Promius Pharma, LLC

Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT02749799     History of Changes
Other Study ID Numbers: DFD-01-CD-014
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases