'anonymous' 'anonymous'
Connexion
M'inscrire

Votre recherche

Filtres

Project précédent
Projet suivant
Nous verifions auprès de chaque centre si des nouvelles informations sont disponibles

831323

Light treatment effectiveness (lite) study
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT03726489
Recrutement fermé
Dernière modification : 2024/09/18
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Limites d'âge
minimum : 12 ans
Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

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

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
    Home Based Phototherapy
    État du recrutement
    unknown
    Données à jour depuis : 18 septembre 2024

    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

    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

    Dernière modification : 18 septembre 2024
    Données à jour depuis : 23 sept.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT03726489