Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT result at within 7 days of the first dose of study drug and practice a reliable method of contraception throughout the study; A female is considered of childbearing potential unless she is:
- - postmenopausal > 5Y, without a uterus and/or both ovaries; or has been surgically sterile for > 6M.
- - hormonal methods or IUD in use > 90d prior to study drug administration, barrier methods plus spermicide in use > 14d prior, or vasectomized partner.
Exclusion Criteria:1. Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while in the study 2. History of hypercalcemia or Vitamin D toxicity or history of significant renal or hepatic disease 3. Patients with guttate, erythrodermic, or pustular psoriasis 4. Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.) 5. Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis 6. Known hypersensitivity to Enstilar Foam or any of its components 7. Current drug or alcohol abuse (Investigator opinion.) 8. Subject unable to commit to all the assessments required by the protocol 9. Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to the Screening Visit.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Derm Research, PLLC|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|L.H. Kircik, M.D.|
|Principal Investigator Affiliation||Skin Sciences, PLLC|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Approximately 30 subjects will be enrolled in a single-center, open-label study of the treatment of psoriasis. There will be a screening/baseline, week 4, week 16 and week 20 visits. Subjects will include those who have been started on commercial Otezla within the last 10 days of baseline. We will add Enstilar foam QD at baseline visit for 4 weeks. Those subjects who achieve clear or almost clear on PGA scale at week 4 will continue on maintenance dose of Enstilar twice weekly on Mondays and Thursdays QD for the next 12 weeks and they will also continue on Otezla. Subjects will continue to week 20 after stopping Enstilar at week 16..
Experimental: Otezla + Enstilar
Drug: - Apremilast 30mg
30mg PO BID started within 10 days of baseline
Drug: - calcipotriene and betamethasone dipropionate
1 application daily starting at baseline and continuing for 4 weeks; those achieving clear or almost clear PGA at week 4 will continue application twice weekly on Monday and Thursday in combination with Otezla. Enstilar application is discontinued at week 16 and study participation continues until week 20.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.