Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06

Study Purpose

The purpose of this study is to evaluate the potential of DFD-06 to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.

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 6 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Subjects and the parent or legal guardian understand the study procedures and agree to participate by giving assent and written informed consent, respectively.
Subject's parent or legal guardian must be willing to authorize use and disclosure of protected health information collected for the study.
  • - Subjects must be at least 6 years and not more than 16.9 years of age, with body weight greater than or equal to 45 pounds at Screening.
  • - Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
  • - Subjects with psoriasis involving ≥10% Body Surface Area (BSA), not including the face, scalp, groin, axillae and other intertriginous areas at the Baseline Visit.
  • - Subjects must have an Investigator Global Assessment (IGA) grade of at least 3 (moderate) at the Baseline Visit.

Exclusion Criteria:

  • - Subject has a current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
  • - Subject has a history of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
  • - Subject has received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
  • - Subject has a history or presence of intracranial hypertension.
- Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease

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.

NCT03179605
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 2
Lead Sponsor

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

Encore Dermatology, Inc.
Principal Investigator

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

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Industry
Overall Status Recruiting
Countries United States
Conditions

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

Psoriasis
Additional Details

This is a 15-day, single arm, multicenter, multi-dose, open-label, two stage, sequential study. In the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). An attempt will be made to enroll subjects throughout the age range of each cohort including the lower age range. DFD-06 will be applied twice daily to all affected areas on the body excluding face, scalp, groin, axillae and other intertriginous areas. Subjects must have ≥10% Body Surface Area (BSA) treated to achieve maximal use exposure.

Arms & Interventions

Arms

Experimental: DFD-06 Cream

This is a single arm, open label study and there will be no reference or control product used in this study

Interventions

Drug: - DFD06

Apply twice per day for 15 days

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.

Site 104, Madera, California

Status

Recruiting

Address

Site 104

Madera, California, 93637

Site Contact

Grace Liu

[email protected]

858-571-1800 #129

Site 108, Santa Ana, California

Status

Recruiting

Address

Site 108

Santa Ana, California, 92705

Site Contact

Grace Liu

[email protected]

858-571-1800 #129

Investigational Site 102, Hialeah, Florida

Status

Recruiting

Address

Investigational Site 102

Hialeah, Florida, 33010

Site Contact

Grace S Liu

[email protected]

858-571-1800 #129

Site 109, Hialeah, Florida

Status

Recruiting

Address

Site 109

Hialeah, Florida, 33012

Site Contact

Grace Liu

[email protected]

858-571-1800 #129

Site 107, Overland Park, Kansas

Status

Recruiting

Address

Site 107

Overland Park, Kansas, 66215

Site Contact

Grace Liu

[email protected]

858-571-1800 #129

Site 103, Saint Louis, Missouri

Status

Recruiting

Address

Site 103

Saint Louis, Missouri, 63141

Site Contact

Grace Liu

[email protected]

858-571-1800 #129

Investigational Site 101, Lincoln, Nebraska

Status

Recruiting

Address

Investigational Site 101

Lincoln, Nebraska, 68522

Site Contact

Grace Liu

[email protected]

858-571-1800 #129

Site 106, Greenville, South Carolina

Status

Recruiting

Address

Site 106

Greenville, South Carolina, 29607

Site Contact

Grace Liu

[email protected]

858-571-1800

Site 105, Spokane, Washington

Status

Recruiting

Address

Site 105

Spokane, Washington, 99203

Site Contact

Greg Jared

[email protected]

509-381-1972

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