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Phase 4 N=45 Treatment

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

Plaque Psoriasis

Enrolled (actual)
45
Serious AEs
2.2%
Results posted
Oct 2020
Primary outcome: Primary: Change in Investigator's Global Assessment Grade — -0.8 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
DFD-01 (betamethasone dipropionate) Spray, 0.05% (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Primus Pharmaceuticals
Primary completion
Jul 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Investigator's Global Assessment Grade
-0.8
PRIMARY
Change in Percent Body Surface Area (BSA) Involved.
-1.3
PRIMARY
Change in Dermatology Life Quality Index (DLQI)
-6.6

Summary

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

Eligibility Criteria

Inclusion Criteria

  • 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.
  • Patient must be at least 18 years of age.
  • Patient must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
  • At least 3% Body Surface Area involved, not including the face, scalp, groin, axillae and other intertriginous areas.
  • 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:
  • Postmenopausal for at least 12 months prior to study product administration;
  • 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:

  • Hormonal methods or intrauterine device in use > 90 days prior to study product administration; or
  • Barrier methods plus spermicide in use at least 14 days prior to study product administration.
  • Partner has had a vasectomy at least 3 months previous to study product administration.
  • 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.

  • 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).
  • Patient is physically able to apply study product to all affected areas or can obtain help.

Exclusion Criteria

  • Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
  • Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
  • Presence of pigmentation, extensive scarring, pigmented lesions, tattoos or sunburn that could interfere with the rating of efficacy parameters.
  • History of psoriasis unresponsive to topical treatments.
  • History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
  • 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.
  • Use within 180 days before Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
  • 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.
  • 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., aci
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02749799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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