A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis

Study Purpose

The aim of the proposed study is to evaluate the efficacy and safety of Enstilar Foam (calcipotriene and betamethasone dipropionate) for the treatment of nail 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 - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Must have a diagnosis of nail psoriasis in fingernail or toenails - History of plaque psoriasis or psoriatic arthritis - Target nail will be KOH negative for dermatophyte fungus - Must give written informed consent prior to study procedures being conducted, also give consent to the release and use of protected health information (PHI) - Between the ages of 18 and 85 years old - Candidate for topical therapy in the opinion of the investigator

Exclusion Criteria:

- Males and Females unable to practice effective contraception throughout the study - Unable to comply with the protocol - Nursing mothers, pregnant women, and women planning to become pregnant while in this study - Patients with erythrodermic or pustular psoriasis - Sustained treatment to target fingernail within 6 months prior to screening - History of trauma or surgery to target fingernail - History of disease known to affect nails such as lichen planus, onychomycosis - History of systemic psoriasis therapy for less than 6 months

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.

NCT04227288
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.

University of Alabama at Birmingham
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Boni E Elewski, Dr
Principal Investigator Affiliation University of Alabama at Birmingham/Dermatology
Agency Class

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

Other
Overall Status Not yet recruiting
Countries United States
Conditions

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

Nail Psoriasis
Additional Details

Eligible subjects will be provided twice daily. Enstilar Foam (calcipotriene and betamethasone dipropionate). Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The patient will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.

Arms & Interventions

Arms

Experimental: Enstilar Foam

Eligible subjects will be provided twice daily daily Enstilar Foam (calcipotriene and betamethasone dipropionate).

Interventions

Drug: - Enstilar Foam

Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The patient will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.

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.

The University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

The University of Alabama at Birmingham

Birmingham, Alabama, 35233

Site Contact

Leslie Roop, BS

[email protected]

205-502-9960

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