- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04246957
Quality of Life Comparison in Patients With Different Types of Alopecia (RDACCQV)
December 1, 2020 updated by: Centre Hospitalier Universitaire, Amiens
Hair loss is a frequent cause of patient consultation in dermatology.
It is known to have a strong impact on patients' quality of life for many reasons; such as esthetic aspect, financial implications, social consequences.
Numerous studies have assessed the impact of some types of alopecia on patients' quality of life.
One study compared the quality of life in patients with scarring alopecia with patients of non-scarring alopecia.
No studies have compared quality of life between the different types of scarring alopecia nor different types of non-scarring alopecia.
However, none have assessed the impact on the patient partner quality of life.
In addition, few treatments for alopecia are covered by national health insurance in France.
The main objective is to compare the impact on the quality of life in different types of alopecia.
By using the average scores of the questionnaire Dermatology Life Quality Index (DLQI) for each type of alopecia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amiens, France, 80480
- CHU Amiens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Every patient consulting in the dermatology department of Amiens' University Hospital for a primary alopecia will have to fill out 2 questionnaires of quality of life: one general (DLQI : Dermatology Life Quality Index) and one specific (Hair Specific Skindex 29).
Every patient partner will have to complete one questionnaire of quality of life: FDLQI (Family DLQI).
Description
Inclusion Criteria:
- patients affiliated to social security
- patients able to understand and fill out a questionnaire
- patients over 18 years old
- patient consulting in the dermatology department of Amiens University Hospital for a primary alopecia
Exclusion Criteria:
- minors
- patients under guardianship, deprived of liberty
- scalp affections other than alopecia
- secondary alopecia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in patient life
Time Frame: at day 0
|
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person.
It is designed for people aged 16 years and above.
There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment.
Each question refers to the impact of the skin disease on the patient's life over the previous week.
Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
|
at day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in spouse life
Time Frame: at day 0
|
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person.
It is designed for people aged 16 years and above.
There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment.
Each question refers to the impact of the skin disease on the patient's life over the previous week.
Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
|
at day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Catherine Lok, Pr, CHU Amiens
- Principal Investigator: Thomas Baltazard, MD, CHU Amiens
- Principal Investigator: Nesrine Zitouni, MD, CHU Amiens
- Principal Investigator: Fanny Dessirier, MD, CHU Amiens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2019
Primary Completion (Actual)
November 16, 2020
Study Completion (Actual)
November 16, 2020
Study Registration Dates
First Submitted
January 21, 2020
First Submitted That Met QC Criteria
January 28, 2020
First Posted (Actual)
January 29, 2020
Study Record Updates
Last Update Posted (Actual)
December 2, 2020
Last Update Submitted That Met QC Criteria
December 1, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2019_843_0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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