- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03212963
Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%
An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Lotion, 0.05% in Subjects 12 to 16 Years 11 Months of Age With Plaque Psoriasis Receiving Two Weeks of Treatment
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is an open label, multicenter study of an investigational formulation of HBP Lotion, 0.05% in male and female subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Approximately 25 subjects with stable plaque psoriasis on at least 10% of their BSA (excluding the face, scalp, groin, axillae and other intertriginous areas), who fulfill the inclusion/exclusion criteria will be enrolled at multiple study sites. All subjects will have a screening CST to assess their HPA axis response at Visit 1 (Screening Visit).
Enrollment into the treatment phase of the study should be timed such that the screening CST will be performed a minimum of 20 days before Baseline Visit. At Visit 2 (Baseline), eligible subjects with normal adrenal function will be eligible to participate in the study.
Subjects will apply HBP Lotion, 0.05% to all psoriasis plaques identified at Visit 2 twice daily (approximately every 12 hours) for the assigned treatment period or until the investigator verifies the subject's psoriasis has cleared. The study is designed to determine the adrenal suppression potential and pharmacokinetic properties of the test article after the subject applies a maximum of approximately 50 grams per week for up to a two week treatment period. All subjects will have a CST to reassess their HPA axis response at EOS (or earlier if the investigator verifies the subject's psoriasis has cleared). In this study, an abnormal Hypothalamujs Pituitary Adrenal axis response to 0.25 milligram dose of cosyntropin is defined as a post-CST serum total cortisol level of less than equal to18 μg/dL.
Eligible subjects will have blood drawn at Screening for baseline drug concentration in plasma. On Day 8, all subjects, regardless of lesion clearance, will have blood drawn for assessment of trough drug concentration in plasma. At the Day 15 visit, subjects who have continued to treat lesions will have a final PK blood sample collected approximately 12 hours after their Day 14 evening application and just prior to the initiation of the CST.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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California
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Fountain Valley, California, États-Unis, 92708
- First OC Dermatology
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Florida
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Hialeah, Florida, États-Unis, 33012
- Power MD Clinical Research Institute
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Missouri
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Saint Joseph, Missouri, États-Unis, 64506
- Medisearch Clinical Trials
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Subject is male or non-pregnant female and is 12 to 16 years 11 months of age.
- 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. 3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% body surface area (BSA) within the Treatment Area. The "Treatment Area" is defined as the entire body exclusive of 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 and Baseline Visits and agree to use an effective form of birth control for the duration of the study.
Exclusion Criteria:
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
- 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.
- Subject has used any phototherapy (including laser), photochemotherapy or systemic psoriasis therapy including methotrexate, retinoids, cyclosporine or biologics within 30 days prior to the initiation of treatment with the test article.
- Subject has used systemic corticosteroids (including oral or intramuscular) or topical, inhaled or intranasal corticosteroids within 30 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.
- 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.
- 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.
- Subject has used emollients/moisturizers on areas to be treated within one day prior to the initiation of treatment with the test article.
- Subject is currently using lithium or Plaquenil (hydroxychloroquine).
- Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has not been stabilized, in the opinion of the investigator.
- Subject has a history of sensitivity to any of the ingredients in the test article.
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Screening).
- Subject has been previously enrolled in this study and treated with the test article.
- Subject has an irregular sleep schedule or works night shifts (cortisol levels exhibit physiological diurnal variation).
- Subject has a screening Cosyntropin Stimulation Test (CST) with a post 30-minute stimulation cortisol level of less than equal to 18 μg/dL.
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Halobetasol lotion treatment arm
All subjects will receive Halobetasol Topical Lotion, 0.05%.
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Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Investigator's Global Assessment
Délai: Day 15
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The IGA score (5-point scale of 0 to 4: 0[clear]; 1[almost clear]; 2[mild]; 3[moderate]; 4[severe]) is an evaluation of the overall severity of a subject's psoriasis in the Treatment Area and takes into consideration the 3 individual characteristics of psoriasis (scaling, erythema, and plaque elevation).
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Day 15
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Percent BSA Affected With Disease
Délai: Day 15
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The Percent Body Surface Area (BSA) Affected with Disease was defined as the BSA which was affected with psoriasis within the Treatment Area.
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Day 15
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Percent Body Surface Area Treated With Test Article
Délai: Day 8
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The Percent Body Surface Area Treated with Test Article was defined as the BSA which was affected with psoriasis within the Treatment Area that was treated.
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Day 8
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Number of Subjects With Abnormal Hypothalamus-Pituitary-Adrenal Axis Response
Délai: Day 15
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An abnormal Hypothalamus-Pituitary-Adrenal (HPA) axis was response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS)
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Day 15
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Stephanie Magajna, MS, Therapeutics, Inc.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 177-0551-201
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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Essais cliniques sur Halobetasol Topical Lotion
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Bausch Health Americas, Inc.Dow Pharmaceutical SciencesComplétéPsoriasis en plaquesÉtats-Unis
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Reata, a wholly owned subsidiary of BiogenAbbVieComplété
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Bausch Health Americas, Inc.Dow Pharmaceutical SciencesComplétéPsoriasis en plaquesÉtats-Unis
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University Hospital MuensterComplété
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Therapeutics, Inc.Complété
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Bausch Health Americas, Inc.Complété
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Dr. Reddy's Laboratories LimitedSyneos Health; AccelovanceComplétéInfestation de poux de têteÉtats-Unis
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Therapeutics, Inc.Complété
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Bausch Health Americas, Inc.Complété
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Dr. Reddy's Laboratories LimitedComplétéInfestation de poux de têteAustralie