The objectives of this study are to evaluate the therapeutic efficacy and safety of
Desoximetasone 0. 25% Shampoo and a Placebo Shampoo in patients with moderate to severe scalp
psoriasis.
Inclusion Criteria:
- Male or non-pregnant, non-lactating females age 12 and older.
- If female of child bearing potential, have a negative urine pregnancy test at
baseline/randomization visits and prepared to abstain from sexual intercourse or use
a reliable method of contraception during the study.
- Signed informed consent form. For patients under the age of majority in the state the
study is being conducted, the parent or legal guardian signs consent and child signs
a patient assent form.
- Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's
Global Assessment score of at least 3 at screening.
- Is in good general health.
Exclusion Criteria:
- Under 12 years of age.
- Females who are pregnant, lactating or likely to become pregnant during the study.
- Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other
concomitant topical therapies during the study.
- Has a scalp skin condition that would interfere with the diagnosis or assessment of
plaque psoriasis of the scalp.
- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the
treatment areas, which could interfere with the rating of efficacy parameters.
- History of psoriasis unresponsive to topical treatments.
- Current immunosuppression.
- Have used the following on the scalp within 2 weeks of screening: topical
corticosteroids, topical anti-psoriatic medication, topical retinoids.
- Have used within 2 weeks of screening beta blockers, lithium preparations,
anti-malarial agents and non-steroidal anti-inflammatory drugs.
- Have used topical corticosteroids on the body within 2 weeks of randomization.
- Use within six months prior to baseline a biologic treatment for psoriasis.
- Use within three months prior to baseline of: chemotherapy or radiation therapy.
- Use within one month prior to baseline of: systemic steroids, systemic antibiotics,
systemic antipsoriatic treatment, psoralen and ultraviolet A therapy, ultraviolet B
therapy, systemic anti-inflammatory agents.
- Have used systemic retinoids within 16 weeks of randomization.
- Use within two months prior to baseline of any immunosuppressive drugs or oral
retinoids.
- Changed brands/types or frequency of use of routine hair care products within 14 days
prior to baseline, or intend to change during the study.
- Received any drug as part of a research study within 30 days prior to dosing.
- Significant history or current evidence of chronic infectious disease, system
disorder, organ disorder or other medical condition that would place the study
participant at undue risk by participation.
- History of allergy or hypersensitivity to desoximetasone or history of any drug
hypersensitivity or intolerance which would compromise the safety of the patient or
the study.
- Current evidence of drug abuse or history of drug abuse within 1 year before the
first dose, including history of alcohol abuse or active alcoholism.
- Inability to understand the protocol requirements, instructions, and study-related
restrictions, the nature, scope, and possible consequences of the clinical study.
- Unlikely to comply with the protocol requirements, instructions, and study-related
restrictions.
- Is a member of the investigational study staff or a member of the family of the
investigational study staff.
- Previous participation in this study.
