To compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis
Source : Importé depuis le centre
The primary objective of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis. Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) will be used to assess effectiveness, safety (tolerability), and duration of treatment response. This is a three year pragmatic, randomized, active comparator effectiveness study.
Source : Importé depuis le centre
RECRUTEMENT
Profil des participants
Limites d'âge
minimum : 12 ans
Sexe(s) des participants
ALL
Source : Importé depuis le centre
Condition médicale (spécialité visée)
Domaine de recherche
Donnée non disponible
Critères de sélection
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Office Based Phototherapy
Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.
Donnée non disponible
Inconnu
Home Based Phototherapy
Patients randomized to this arm will receive narrow band phototherapy in a home setting via Daavlin 7 series 3 panel narrow band phototherapy home units.
Donnée non disponible
Inconnu
Office Based Phototherapy
État du recrutement
unknown
Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.
Home Based Phototherapy
État du recrutement
unknown
Patients randomized to this arm will receive narrow band phototherapy in a home setting via Daavlin 7 series 3 panel narrow band phototherapy home units.
Données à jour depuis :
18 septembre 2024
SITES ET CONTACTS
Centre principal
total skin & beauty dermatology center
BIRMINGHAM, ALABAMA, UNITED STATES
Recrutement local
—
FERMÉ
Aussi disponible à: FORT SMITH, (ARKANSAS), SAN FRANCISCO, (CALIFORNIA), WASHINGTON, (DISTRICT OF COLUMBIA), CHICAGO, (ILLINOIS), NEW ORLEANS, (LOUISIANA), PORTLAND, (MAINE), SILVER SPRING, (MARYLAND), BOSTON, (MASSACHUSETTS), BRIGHTON, (MICHIGAN), BRONX, (NEW YORK), BROOKLYN, (NEW YORK), ...
et 26 autres villes.
Dernière modification :
18 septembre 2024
Données à jour depuis :
23 sept.
Origine des données :
clinicaltrials.gov
1. Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
2. Age 12 or older
3. Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of \>1.0, and considered a candidate for phototherapy
4. Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
1. In office: Able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site
2. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
5. New or established patient in the practice
Exclusion Criteria:
1. Patients who are judged unable or unwilling to comply with either in office or in home phototherapy due to time, work, school, or other financial constraints
2. Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:
1. How to operate the phototherapy device
2. How to follow the dosing protocol
3. Requirement to wear protective eyewear and genital protection equipment
3. Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
4. Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
5. Patients deemed unsafe to be treated with phototherapy:
1. History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
2. History of arsenic intake
3. Unable to tolerate standing for required duration of treatment due to age or physical function
4. History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
6. Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Office Based Phototherapy
Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.
Donnée non disponible
Inconnu
Home Based Phototherapy
Patients randomized to this arm will receive narrow band phototherapy in a home setting via Daavlin 7 series 3 panel narrow band phototherapy home units.
Donnée non disponible
Inconnu
Office Based Phototherapy
État du recrutement
unknown
Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.
Home Based Phototherapy
État du recrutement
unknown
Patients randomized to this arm will receive narrow band phototherapy in a home setting via Daavlin 7 series 3 panel narrow band phototherapy home units.
Données à jour depuis :
18 septembre 2024
Description de l'étude
Description de l'étude
Résumé de l'étude
To compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis
Source : Importé depuis le centre
The primary objective of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis. Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) will be used to assess effectiveness, safety (tolerability), and duration of treatment response. This is a three year pragmatic, randomized, active comparator effectiveness study.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
10
affichés
sur
38
centres
BRIGHAM AND WOMEN'S HOSPITAL
Boston
MASSACHUSETTS, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
BUFFALO MEDICAL GROUP
Williamsville
NEW YORK, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
DAWES FRETZIN CLINICAL RESEARCH GROUP, LLC
Indianapolis
INDIANA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
DERMASSOCIATES LLC
Silver spring
MARYLAND, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
DERMATOLOGY SPECIALIST OF BRIGHTON
Brighton
MICHIGAN, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
DERMATOLOGY TREATMENT AND RESEARCH CENTER
Dallas
TEXAS, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
FRONTIER DERM PARTNERS CRO, LLC
Mill creek
WASHINGTON, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
GEORGE WASHINGTON UNIVERSITY MEDICAL FACULTY ASSOCIATES /ID# 238011
Washington
DISTRICT OF COLUMBIA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
HENRY FORD HEALTH SYSTEM, DEPT OF OPHTHALMOLOGY AND EYE CARE SERVICES
Detroit
MICHIGAN, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
HEYMANN, MANDERS, GREEN, AND SOMMER, LLC
Marlton
NEW JERSEY, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
Centres participants
Source d'information
Dernière modification :
18 septembre 2024
Données à jour depuis :
23 sept.
Origine des données :
clinicaltrials.gov