NCT04246957

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

January 21, 2020

Last Update Submit

December 1, 2020

Conditions

AlopeciaQuality of Life

Keywords

alopeciaquality of lifepartner

Outcome Measures

Primary Outcomes (1)

  • Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in patient life

    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 Outcomes (1)

  • Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in spouse life

    at day 0

Interventions

general quality of life questionaryBEHAVIORAL

Every patient will have to fill out a general quality of life questionary : DLQI (Dermatology Life Quality Index)

specific quality of life questionaryBEHAVIORAL

Every patient will have to fill out a specific quality of life questionary : Hair Specific Skindex 29.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • minors
  • patients under guardianship, deprived of liberty
  • scalp affections other than alopecia
  • secondary alopecia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 29, 2020

Study Start

March 4, 2019

Primary Completion

November 16, 2020

Study Completion

November 16, 2020

Last Updated

December 2, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)