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Trial record 4 of 92 for:    cream | "Psoriasis"

A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02635204
Recruitment Status : Completed
First Posted : December 18, 2015
Results First Posted : April 13, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

Brief Summary:
This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: DFD06 Cream Drug: Vehicle Cream Phase 3

Detailed Description:
This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days
Study Start Date : December 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: DFD-06 Cream
DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Drug: DFD06 Cream
Twice daily topical application for 14 days.
Other Name: Clobetasol propionate Cream, 0.025%

Placebo Comparator: Vehicle Cream
Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Drug: Vehicle Cream
Twice daily topical application for 14 days.




Primary Outcome Measures :
  1. Percentage of Subjects With Treatment Success at Day 15 [ Time Frame: Day 15 Visit ]
    The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Body Surface Area at Day 15 [ Time Frame: Baseline and Day 15 ]
    Percent change from baseline in body surface area affected by psoriasis at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

  2. Percent of Subjects With Treatment Success at Day 8 Visit [ Time Frame: Baseline and Day 8 ]
    Percent of subjects with treatment success at Day 8 Visit defined as an IGA of 0 or 1 with at least a 2 grade reduction from baseline. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.



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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. Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study.
  2. Subject must be at least 18 years of age.
  3. Subject must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
  4. Subject with psoriasis involving 3% or greater BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
  5. Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.
  6. Female subjects of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the subject become sexually active. All women of childbearing potential must complete a urine pregnancy test (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must be negative to be eligible for enrollment.
  7. Subject 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 (blood pressure and pulse).

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, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
  4. History of psoriasis unresponsive to biological or topical treatments.
  5. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
  6. Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
  7. 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.
  8. Use within 60 days prior to 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).
  9. Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.
  10. Use within 14 days prior to 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.
  11. Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.

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): NCT02635204


  Show 30 Study Locations
Sponsors and Collaborators
Promius Pharma, LLC
Investigators
Study Director: Srinivas Sidgiddi, MD Dr. Reddy's Laboratories, Inc

Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT02635204     History of Changes
Other Study ID Numbers: DFD06-CD-004
First Posted: December 18, 2015    Key Record Dates
Results First Posted: April 13, 2018
Last Update Posted: May 15, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs