Phase
Condition
Skin Wounds
Rash
Scalp Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: I. Outpatient, male or female subjects of any race, 18 years of age or higher. Femalesubjects of childbearing potential must have a (-)UPT (urine pregnancy test) result atwithin 7 days of the first dose of study drug and practice a reliable method ofcontraception throughout the study; A female is considered of childbearing potential unless she is:
postmenopausal ≥ 5 years of age, without a uterus and/or both ovaries; or has beensurgically sterile for ≥ 6 moths. Reliable methods of contraception are:
hormonal methods or IUD (intrauterine device) in use ≥ 90 days prior to study drugadministration, barrier methods plus spermicide in use ≥ 14 days prior, or vasectomizedpartner.
[Exception: Female subjects of CBP (child bearing potential) who are not sexually activeare not required to practice a reliable method of contraception and may be enrolled at theInvestigator's discretion provided they are counseled to remain sexually inactive for theduration of the study and understand the risks involved in getting pregnant during thestudy.] ii. Subjects with moderate plaque type psoriasis who have been started oncommercial Otezla within the last 10 days. iii. Physician Global Assessment (PGA) score of 3. iv. Able to understand studyrequirements and sign Informed Consent/HIPAA forms.
Exclusion
Exclusion Criteria: I. Female subjects who are pregnant, breast-feeding, or who are of childbearing potentialand not practicing a reliable method of birth control, or male subjects planning apregnancy with their spouse or partner while in the study. ii. History of hypercalcemia or vitamin D toxicity or history of significant renal orhepatic disease iii. Patients with guttate, erythrodermic, or pustular psoriasis iv.Serious skin condition (other than psoriasis) or uncontrolled medical condition (in theopinion of the investigator). v. Skin conditions (e.g.eczema) other than psoriasis that may interfere with evaluations ofpsoriasis. vi. Known hypersensitivity to Enstilar Foam or any of its components. vii. Current drug oralcohol abuse (Investigator opinion). viii. Subject unable to commit to all the assessmentsrequired by the protocol. ix. Current enrollment in another clinical study and treatmentwith another experimental drug or approved therapy for experimental use within 30 daysprior to the Screening Visit.
Study Design
Study Description
Connect with a study center
Center for Dermatology and Laser Surgery
Sacramento, California 95819
United StatesSite Not Available
Skin Sciences, PLLC
Louisville, Kentucky 40217
United StatesSite Not Available
Lawrence J. Green, MD LLC
Rockville, Maryland 20850
United StatesSite Not Available
Dermatology & Laser Center of Charleston
Charleston, South Carolina 29414
United StatesSite Not Available
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