NCT03414476

Brief Summary

In this study, the investigator will try to highlight the presence of carbonyl compounds in the hair follicles of women with telogen effluvium (ET) linked to stress of various origins (fatigue, infectious diseases, emotional stress ...).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

January 10, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

January 10, 2018

Last Update Submit

January 16, 2020

Conditions

Effluvium; Telogen

Outcome Measures

Primary Outcomes (1)

  • Biological evaluation

    Evaluation of the quantity of carbonyl compounds measured in the hair follicles taken from the two groups.

    Visit 1- Day 1

Secondary Outcomes (1)

  • Safety evaluation

    Visit 1- Day 1

Study Arms (2)

ET group

EXPERIMENTAL

Sampling : Hair follicles sampling on the scalp in women with Telogene Effluvium

Other: Hair follicles sampling

Control group

EXPERIMENTAL

Sampling: Hair follicles sampling on the scalp in women without Telogene Effluvium

Other: Hair follicles sampling

Interventions

Hair follicles samplingOTHER

The follicles will be collected by lock of 10 hair on the scalp (centro-parietal part), to obtain 40 follicles with epithelial sheath

Control groupET group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Criteria related to the Population :
  • Women aged from 18 to 40 ans (included)
  • Phototype I à IV included, according to Fitzpatrick Classification
  • Hair length 5 cm on the sampling area (centro-parietal part)
  • Informed consent signature
  • Criteria related to the studied condition:
  • ET group: hair loss related to various etiologies evaluated by a questionnaire according to the investigator's opinion and positive pull test (at least 3 hair collected per lock of 50 to 60 hair) AND
  • Control group : no hair loss, evaluated by the questionnaire and negative pull test (less than 3 hair collected per lock of 50 to 60 hair)

You may not qualify if:

  • Criteria related to Population :
  • Menopause
  • Pregnancy, breastfeeding, childbirth for less than 6 months
  • Criteria related to Pathology :
  • For both groups:
  • Alopecia causing hair loss on the upper part of the scalp
  • Dermatological pathology or evolving cutaneous lesion in the scalp
  • Control group only:
  • Chronic unstabilized condition
  • Acute evolving pathology
  • Criteria related to theTreatments :
  • For both groups:
  • Systemic treatment affecting hair growth
  • Any treatment or dietary supplement for antioxidant or capillary
  • Control group only:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre hospitalier Lyon Sud

Lyon, 69007, France

Location

Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Nice, 06202, France

Location

Centre de santé SABOURAUD

Paris, 75010, France

Location

INTERTEK France

Paris, 75013, France

Location

Centre de Recherche sur la Peau

Toulouse, 31025, France

Location

Laboratoire Dermscan

Villeurbanne, 69100, France

Location

Study Officials

  • Christine SAINT MARTORY, MD

    Unaffiliate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Monocentric, Exploratory study, open, comparative, in parallel groups
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 1 group of women with effluvium télogène 1 group of women without effluvium télogène
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 30, 2018

Study Start

March 26, 2018

Primary Completion

June 25, 2018

Study Completion

June 25, 2018

Last Updated

January 21, 2020

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Proof of concept study, with confidential data

Locations

FR(6)