Phase
Condition
Rosacea
Skin Wounds
Warts
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study:
Males or females, ≥ 18 years of age at the time of signing the informed consentdocument
Be willing and able to adhere to the study visit schedule and other protocolrequirements.
Have a diagnosis of moderate to severe plaque psoriasis of the scalp at screening andbaseline
Must be a candidate for phototherapy and/or systemic therapy for either body or scalppsoriasis lesions.
Have moderate to severe plaque psoriasis at screening and baseline
Must be in good health (except for psoriasis) as judged by the Investigator, based onmedical history, physical examination, 12-lead electrocardiogram (ECG), clinicallaboratories, and urinalysis
Must meet laboratory criteria
Females of childbearing potential (FCBP)* must have a negative pregnancy test atscreening and baseline. While on investigational product (IP) and for at least 28 daysafter taking the last dose of investigational product, FCBP who engage in activity inwhich conception is possible - must use one of the approved contraceptive** optionsdescribed below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral,injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tuballigation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom ornonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUSone additional barrier method: (a) diaphragm with spermicide; (b) cervical cap withspermicide; or (c) contraceptive sponge with spermicide.
*A female of childbearing potential is a sexually mature female who 1) has not undergone ahysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgicalremoval of both ovaries) or 2) has not been postmenopausal for at least 24 consecutivemonths (that is, has had menses at any time during the preceding 24 consecutive months).
** The female subject's chosen form of contraception must be effective by the time thefemale subject is randomized into the study (for example, hormonal contraception should beinitiated at least 28 days before randomization).
Exclusion
Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment:
Other than psoriasis, history of any clinically significant uncontrolled disease. Any condition, including the presence of laboratory abnormalities, which would place thesubject at unacceptable risk if he/she were to participate in the study.
Pregnant or breast feeding
Hepatitis B surface antigen positive at screening
Anti-hepatitis C antibody positive at screening
Active tuberculosis (TB) or a history of incompletely treated TB
Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
History of positive human immunodeficiency virus (HIV), or have congenital or acquiredimmunodeficiency (eg, common variable immunodeficiency disease)
Active substance abuse or a history of substance abuse within 6 months prior tosigning the informed consent form.
Bacterial infections requiring treatment with oral or injectable antibiotics, orsignificant viral or fungal infections, within 4 weeks of signing the informed consentform.
Malignancy or history of malignancy, except for treated (i.e., cured) basal cell orsquamous cell in situ skin carcinomas or treated (i.e., cured) cervicalintraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence ofrecurrence within 5 years of signing the informed consent.
Prior history of suicide attempt at any time in the subject's life time prior tosigning the informed consent and randomization, or major psychiatric illness requiringhospitalization within the last 3 years prior to signing the informed consent.
Psoriasis flare/rebound within 4 weeks of signing the informed consent form or betweenthe screening and baseline visits.
Topical therapy within 2 weeks prior to randomization; Conventional systemic therapyfor psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids onthe scalp within 2 weeks prior to randomization; Phototherapy treatment of body orscalp psoriasi lesions within 4 weeks prior to randomization; Biologic therapy between 12 weeks to 24 weeks prior to randomization
Use of any investigational drug beginning 4 weeks prior to randomization, or 5pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) lightsources
Prior treatment with apremilast
History of allergy or hypersensitivity to any components of the Investigationalproduct.
Study Design
Study Description
Connect with a study center
Institute for Skin Advancement
Calgary, Alberta T3A 2N1
CanadaSite Not Available
Kirk Barber Research
Calgary, Alberta T2G 1B1
CanadaSite Not Available
Chih-Ho Hong Medical, Inc.
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
Enverus Medical Research
Surrey, British Columbia V3V 0C6
CanadaSite Not Available
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba R3M 3Z4
CanadaSite Not Available
New Lab Clinical Research
Saint Johns, Newfoundland and Labrador A1C 2H5
CanadaSite Not Available
Eastern Canada Cutaneous Research Associates Ltd
Halifax, Nova Scotia B3H 1Z4
CanadaSite Not Available
Lynderm Research
Markham, Ontario L3P1X2
CanadaSite Not Available
North Bay Dermatology Center
North Bay, Ontario P1B 3Z7
CanadaSite Not Available
Skin Center for Dermatology
Peterborough, Ontario K9J 5K2
CanadaSite Not Available
Centre For Dermatology and Cosmetic Surgery
Richmond Hill, Ontario L4B 1A5
CanadaSite Not Available
The Toronto Dermatology Centre
Toronto, Ontario M3H 5Y8
CanadaSite Not Available
K. Papp Clinical Research
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
XLR8 Medical Research
Windsor, Ontario N8W 1E6
CanadaSite Not Available
Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
Quebec, G1V 4X7
CanadaSite Not Available
Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
Rogers, Arkansas 72758
United StatesSite Not Available
Tien Q. Nguyen MD Inc
Fountain Valley, California 92708
United StatesSite Not Available
Dermatology Research Associates
Los Angeles, California 90045
United StatesSite Not Available
San Luis Dermatology and Laser Clinic
San Luis Obispo, California 93405
United StatesSite Not Available
University of Connecticut
Farmington, Connecticut 06030
United StatesSite Not Available
Florida Academic Centers Research and Education
Coral Gables, Florida 33134
United StatesSite Not Available
International Dermatology Research
Miami, Florida 33144
United StatesSite Not Available
Renstar Medical Research
Ocala, Florida 34470
United StatesSite Not Available
Dermatologic Surgery Specialists, P.C.
Macon, Georgia 31217
United StatesSite Not Available
MedaPhase INC
Newnan, Georgia 30263
United StatesSite Not Available
Forefront Dermatology
Carmel, Indiana 46032
United StatesSite Not Available
The Indiana Clinical Trials Center, PC
Plainfield, Indiana 46168
United StatesSite Not Available
DS Research
Louisville, Kentucky 40241
United StatesSite Not Available
Dermatology and Advanced Aesthetics
Lake Charles, Louisiana 70605
United StatesSite Not Available
Lawrence Green, MD, LLC
Rockville, Maryland 20850
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Central Dermatology
Saint Louis, Missouri 63117
United StatesSite Not Available
Skin Specialists, PC
Omaha, Nebraska 68144
United StatesSite Not Available
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey 08520
United StatesSite Not Available
SUNY Downstate Medical Center
Brooklyn, New York 11203
United StatesSite Not Available
Forest Hills Dermatology Group
Forest Hills, New York 11375
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai Medical Center
New York, New York 10029
United StatesSite Not Available
Sadick Research Group
New York, New York 10075
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27104
United StatesSite Not Available
San Luis Dermatology and Laser Clinic
Dayton, Ohio 45408
United StatesSite Not Available
Wright State Physicians
Fairborn, Ohio 45324
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Austin Dermatology Associates
Austin, Texas 78705
United StatesSite Not Available
Modern Research Associates PLLC
Dallas, Texas 75231
United StatesSite Not Available
Center for Clinical Studies
Webster, Texas 77598
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84107
United StatesSite Not Available
Eastern Virginia Medical School
Norfolk, Virginia 23507
United StatesSite Not Available
Virginia Clinical Research Inc
Norfolk, Virginia 23502
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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