Last updated: December 29, 2020
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Completed
Phase
4
Condition
Rosacea
Psoriasis And Psoriatic Disorders
Rash
Treatment
N/AClinical Study ID
NCT03506477
GCO 17-2468
HSM# 17-05032
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Provide written, signed and dated informed consent prior to initiating anystudy-related activities.
- Male or female >18 years of age at the time of screening
- Fitzpatrick Skin phototype IV-VI, non-white race/ethnicity, including but not limitedto - --African Americans, Asians, Pacific Islanders and Hispanics.
- Clinical diagnosis of chronic plaque-type psoriasis of the body
- Plaque psoriasis with ≥2% Body Surface Area (BSA) involvement (may include scalpinvolvement), PASI Score ≥ 2, IGA mod 2011 score of 2 or greater (based on scale of 0-4)
- Females of childbearing potential (FCBP) must have a negative pregnancy test atScreening and Baseline. While using investigational product and for at least 28 daysafter last application of investigational product, FCBP who engage in activity inwhich conception is possible must use one of the approved contraceptive options d
- Must be in general good health as judged by the Investigator, based on medical historyand physical examination.
Exclusion
Exclusion Criteria:
- Form of diagnosed psoriasis other than chronic plaque psoriasis (i.e. guttate,erythrodermic, pustular)
- Diagnosis of other active, ongoing skin diseases or skin infections that may interferewith examination of psoriasis lesions
- Ongoing use of other psoriasis treatment including but not limited to topical orsystemic corticosteroids, other topical medications (i.e. coal tar), oral or biologicmedications for the treatment of psoriasis, and UV therapy. The following washoutperiods will be required: 2 weeks for topical therapy; 2 weeks for phototherapy; 12weeks for biologic or targeted therapies; 4 weeks for other systemic therapies
- Use of oral estrogen therapy, excluding oral contraceptive pills
- Women who are pregnant, nursing, or of child-bearing potential who are unwilling touse appropriate method(s) of contraception.
- Patients unwilling to limit exposure to UV light
- Current significant medical problems that, in the discretion of the investigator,would put the patient at significant risk
- Patients with disorders of calcium metabolism and/or hypercalcemia
- Use of any investigational drug within 4 weeks prior to randomization, or 5pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
- History of allergy to any component of the IP
Study Design
Total Participants: 25
Study Start date:
May 21, 2018
Estimated Completion Date:
September 25, 2019
Study Description
Connect with a study center
Mount Sinai West
New York, New York 10023
United StatesSite Not Available

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