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The study is a multi-center, longitudinal, observational study to describe longitudinal trajectories of Clinician-Reported Outcomes (ClinROs) and Patient-Reported Outcomes (PROs) in patients with select dermatological conditions. This study will collect data using validated clinical instruments and patient-reported data on the disease course of alopecia areata (AA), atopic dermatitis (AD), hidradenitis suppurativa (HS), psoriasis (PsO), and vitiligo (VL), including symptom assessments and quality of life (QoL) measures from a patient perspective, to supplement routine clinical data collected from their healthcare providers. ClinRO data will be collected at baseline and routine follow-up visits for up to two years. PRO data will be collected directly from patients at baseline and at pre-specified follow-up time points (as defined in Tables 1 – 2e) for up to two years.
The objectives of this study are:
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Recruitment Status :
Enrolling by invitation
First Posted : December 9, 2022
Last Update Posted : January 31, 2023
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05056168 |
|
Recruitment Status : **RECRUITING NOW**
First Posted : September 24, 2021 Last Update Posted : December 15, 2022 |
Sponsor:
Collaborators:
Information provided by (Responsible Party):
April Armstrong, University of Southern California
Brief Summary:
The primary objective of this study is to validate a dermatology-specific questionnaire that assesses patient satisfaction with their treatments across various inflammatory dermatology diseases.
| Psoriasis | Other: Dermatology-Specific Treatment Satisfaction Instrument |
| Study Type : | Observational |
| Estimated Enrollment : | 120 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Validation of a Dermatology-Specific Treatment Satisfaction Instrument |
| Actual Study Start Date : | November 13, 2021 |
| Estimated Primary Completion Date : | March 2023 |
| Estimated Study Completion Date : | May 2023 |
Study subjects will also be administered a dermatology-specific treatment satisfaction questionnaire, as well as other questionnaires including the generic validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) and the validated Dermatology Life Quality Index (DLQI). Study participants will also self-report their disease severity using PGA. Depending on patients’ preferred method of interacting with the study team, the investigators will collect their responses to these questionnaires either in-person, over the phone, or electronically via secure research platforms.
For this survey study, the investigators will gather descriptive statistics for each item in the questionnaire. The investigators will also measure the following psychometric properties: measurement error, reliability and construct validity, as measured by convergent and known-groups validity
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study:  | 18 Years and older  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | All |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | Non-Probability Sample |
Adult (≥ 18 years) dermatology patients with psoriasis from LAC+USC and Keck Medical Centers, the Brigham and Women’s Hospital, and the Mount Sinai Hospital.
Inclusion Criteria:
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): NCT05056168
| University of Southern California | |
| Los Angeles, California, United States, 90089 | |
| Contact: Gina Kostandy, MPH   323-865-3641   gina.kostandy@med.usc.edu   | |
| Principal Investigator: April W Armstrong, MD, MPH Â Â Â Â Â Â | |
University of Southern California
Icahn School of Medicine at Mount Sinai
Brigham and Women’s Hospital
| Principal Investigator: | April Armstrong, MD, MPH | University of Southern California |
| Responsible Party: | April Armstrong, Professor, University of Southern California |
| ClinicalTrials.gov Identifier: | NCT05056168 Â Â |
| Other Study ID Numbers: | HS-18-00891-AM004 |
| First Posted: | September 24, 2021 Â Â Key Record Dates |
| Last Update Posted: | December 15, 2022 |
| Last Verified: | December 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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