The research study to find out if the study drug, halobetasol propionate foam, 0.05%, is safe to give to children and teenagers who have plaque psoriasis.
- Conditions
- Plaque psoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-003845-40-PL
- Lead Sponsor
- Mayne Pharma LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
1. Subject is male or non-pregnant female and is 12 to less than 18 years of age (i.e., at least 12 years old, but not yet reached their 18th birthday at the time of enrollment).
2. Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian has provided informed consent for the subject. If a subject becomes 18 years of age during the study, the subject must provide written informed consent at the next study visit to continue study participation.
3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% BSA (excluding the face, scalp, groin, axillae and other intertriginous areas).
4. Subject has an Investigator’s Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
5. Subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
6. Females must have a negative urine pregnancy test (UPT) at the Screening (Part B) and Baseline Visits and agree to use an effective form of birth control for the duration of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
2. Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
3. Subject has a physical condition which, in the investigator’s opinion, might impair evaluation of plaque psoriasis, adrenal axis function (e.g., Addison’s Disease, Cushing’s Syndrome) or which exposes the subject to an unacceptable risk by study participation.
4. Subject has used any phototherapy (including laser), photo-chemotherapy, or systemic psoriasis therapy including methotrexate, retinoids, cyclosporine, or biologics within 30 days prior to the initiation of treatment with the test article.
5. Subject has used systemic corticosteroids (including oral or intramuscular) or topical, inhaled, or intranasal corticosteroids within 30 days or 14 days, respectively, prior to Part B of the Screening Visit and/or the subject has used systemic or topical corticosteroids between Part B of the Screening Visit and the initiation of treatment.
6. 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.
7. Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to the initiation of treatment with the test article.
8. Subject has used emollients/moisturizers on areas to be treated within one day prior to the initiation of treatment with the test article.
9. Subject is currently using lithium or Plaquenil (hydroxychloroquine).
10. Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme inhibitors (e.g., lisinopril) at a dose that has not been stabilized, in the opinion of the investigator.
11. Subject has a history of sensitivity to any of the ingredients in the test article (see Section 6.1).
12. Subject is pregnant, lactating, or is planning to become pregnant during the study.
13. Subject is currently enrolled in an investigational drug or device study.
14. Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Screening).
15. Subject has been previously enrolled in this study and treated with the test article.
16. Subject has an irregular sleep schedule or works night shifts (cortisol levels exhibit physiological diurnal variation).
17. Subject has a screening CST with a post 30-minute stimulation cortisol level of = 18 µg/dL.
18. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to determine the adrenal suppression potential and the pharmacokinetic (PK) properties of HBP Foam, 0.05% applied twice daily in subjects aged who are 12 to less than 18 years of age with stable plaque psoriasis. ;Secondary Objective: None.;Primary end point(s): 1) HPA Axis Response to Cosyntropin - Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin (Cortrosyn® tests). HPA axis suppression is defined as a post-stimulation serum cortisol level < 18 µg/dL assessed at the end of study. <br>2) Plasma Levels of HBP - Trough HBP concentrations in plasma will be assessed at Screening, Day 8, and Day 15 approximately 12 hours (± 30 minutes) post-treatment. <br><br>;Timepoint(s) of evaluation of this end point: 1) At the end of study.<br>2) At Screening, Day 8, and Day 15/EOS approximately 12 hour post-treatment. <br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Other Safety Endpoints - AEs, LSRs, UPTs, dosing compliance, and extent of exposure.;Timepoint(s) of evaluation of this end point: At the end of study.