Demonstration of Carbonyl Stress on Hair Follicles

Demonstration of the Presence of Carbonyl Stress in the Hair Follicles of Women With Reactive Hair Loss

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 ...).

Study Overview

• Status: Completed
• Conditions: Effluvium; Telogen
• Intervention / Treatment: Other: Hair follicles sampling

Detailed Description

At the cutaneous level, oxidative stress induces the formation of carbonyl compounds which, by binding to proteins, produce nonfunctional adducts inducing cutaneous aging. Is this mechanism, called "Carbonyl stress", also present in the scalp and can it be one of the mechanisms involved in the occurrence of reactive hair loss ? To demonstrate this, samples of hair follicles are made. The proteins are extracted from the samples and then assayed. The oxidized (carbonyl) proteins are labeled with specific fluorescent probes.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69007
    • Centre Hospitalier Lyon Sud
  • Nice, France, 06202
    • Centre de Pharmacologie Clinique Appliquée à la Dermatologie
  • Paris, France, 75010
    • Centre de Sante Sabouraud
  • Paris, France, 75013
    • INTERTEK France
  • Toulouse, France, 31025
    • Centre de Recherche sur la Peau
  • Villeurbanne, France, 69100
    • Laboratoire Dermscan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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)
• Last shampoo at least 2 days before the inclusion visit, without application of styling product, care or water between this last shampoo and the inclusion
• 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)

Exclusion Criteria:

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:

• Use for at least 1 month of Minoxidil, Aminexil in the 3 months before inclusion or ongoing
• Systemic treatment affecting hair growth
• Any treatment or dietary supplement for antioxidant or capillary

Control group only:

• Treatment of general thyroid disorders initiated or modified for less than 3 months prior to inclusion
• Treatment of anemia if started less than 3 months before inclusion
• General treatment initiated or modified for less than 3 months prior to inclusion in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ET group; Sampling : Hair follicles sampling on the scalp in women with Telogene Effluvium	Other: Hair follicles sampling; The follicles will be collected by lock of 10 hair on the scalp (centro-parietal part), to obtain 40 follicles with epithelial sheath
Experimental: Control group; Sampling: Hair follicles sampling on the scalp in women without Telogene Effluvium	Other: Hair follicles sampling; The follicles will be collected by lock of 10 hair on the scalp (centro-parietal part), to obtain 40 follicles with epithelial sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological evaluation	Evaluation of the quantity of carbonyl compounds measured in the hair follicles taken from the two groups.	Visit 1- Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	Adverse events evaluation	Visit 1- Day 1

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Principal Investigator: Christine SAINT MARTORY, MD, Unaffiliate

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: STRESSCARBONYL1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Proof of concept study, with confidential data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No