Trial record 10 of 19 for:
"Secondary Adrenal Insufficiency" | "Respiratory System Agents"
Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06
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| ClinicalTrials.gov Identifier: NCT03179605 |
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Recruitment Status :
Recruiting
First Posted : June 7, 2017
Last Update Posted : February 15, 2019
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Sponsor:
Encore Dermatology, Inc.
Information provided by (Responsible Party):
Encore Dermatology, Inc.
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriasis | Drug: DFD06 | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | 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). |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06 in Pediatric Subjects With Moderate to Severe Plaque Psoriasis |
| Actual Study Start Date : | May 2, 2017 |
| Estimated Primary Completion Date : | June 30, 2019 |
| Estimated Study Completion Date : | June 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: DFD06
Apply twice per day for 15 days |
Primary Outcome Measures :
- Proportion of subjects with HPA axis suppression at Day 15 [ Time Frame: Day 15 ]The proportion of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level ≤18 µg/dL at 30 minutes post stimulation) is the primary variable
Secondary Outcome Measures :
- Change in IGA grade [ Time Frame: Baseline up to Day 15 ]IGA grades will be recorded at all visits and provided as descriptive statistics to show change from Baseline.
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| Ages Eligible for Study: | 6 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179605
Locations
| United States, California | |
| Site 104 | Recruiting |
| Madera, California, United States, 93637 | |
| Contact: Grace Liu 858-571-1800 ext 129 gliu@therapeuticsinc.com | |
| Site 108 | Recruiting |
| Santa Ana, California, United States, 92705 | |
| Contact: Grace Liu 858-571-1800 ext 129 gliu@therapeuticsinc.com | |
| United States, Florida | |
| Investigational Site 102 | Recruiting |
| Hialeah, Florida, United States, 33010 | |
| Contact: Grace S Liu 858-571-1800 ext 129 gliu@therapeuticsinc.com | |
| Site 109 | Recruiting |
| Hialeah, Florida, United States, 33012 | |
| Contact: Grace Liu 858-571-1800 ext 129 gliu@therapeuticsinc.com | |
| United States, Kansas | |
| Site 107 | Recruiting |
| Overland Park, Kansas, United States, 66215 | |
| Contact: Grace Liu 858-571-1800 ext 129 gliu@therapeuticsinc.com | |
| United States, Missouri | |
| Site 103 | Recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| Contact: Grace Liu 858-571-1800 ext 129 gliu@therapeuticsinc.com | |
| United States, Nebraska | |
| Investigational Site 101 | Recruiting |
| Lincoln, Nebraska, United States, 68522 | |
| Contact: Grace Liu 858-571-1800 ext 129 gliu@therapeuticsinc.com | |
| Principal Investigator: PI Site 1, MD | |
| United States, South Carolina | |
| Site 106 | Recruiting |
| Greenville, South Carolina, United States, 29607 | |
| Contact: Grace Liu 858-571-1800 gliu@therapeuticsinc.com | |
| United States, Washington | |
| Site 105 | Recruiting |
| Spokane, Washington, United States, 99203 | |
| Contact: Greg Jared 509-381-1972 greg@principleresearchsolutions.com | |
| Principal Investigator: Katherine Reed, MD | |
Sponsors and Collaborators
Encore Dermatology, Inc.
| Responsible Party: | Encore Dermatology, Inc. |
| ClinicalTrials.gov Identifier: | NCT03179605 History of Changes |
| Other Study ID Numbers: |
DFD-06-CD-011 |
| First Posted: | June 7, 2017 Key Record Dates |
| Last Update Posted: | February 15, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Respiratory System Agents Psoriasis Skin Diseases, Papulosquamous Skin Diseases Epinephrine Racepinephrine Epinephryl borate Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Mydriatics Sympathomimetics Vasoconstrictor Agents |