The Maintenance Effect of Enstilar Foam in Combination With Otezla

Study Purpose

This is a single-center, open-label study. Approximately 30 qualified subjects will be enrolled in a study lasting 20 weeks which investigates the effect of Enstilar used in combination with Otezla to treat psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.
Reliable methods of contraception are:
  • - hormonal methods or IUD in use > 90d prior to study drug administration, barrier methods plus spermicide in use > 14d prior, or vasectomized partner.
[Exception: Female subjects of CBP who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.] 2. Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days 3. Physician Global Assessment (PGA) score of 3 4. Able to understand study requirements and sign Informed Consent/HIPAA forms

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.

Trial Details

Trial ID:

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.

NCT04555707
Phase

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.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Derm Research, PLLC
Principal Investigator

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
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

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..

Arms & Interventions

Arms

Experimental: Otezla + Enstilar

Interventions

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.

Skin Sciences, PLLC, Louisville, Kentucky

Status

Recruiting

Address

Skin Sciences, PLLC

Louisville, Kentucky, 40217

Site Contact

Senen Pena Oliva, MSN

[email protected]

502-451-9000

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