Demonstration of Carbonyl Stress on Hair Follicles

NCT ID: NCT03414476

Last Updated: 2020-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2018-06-25

Brief Summary

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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 ...).

Detailed Description

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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.

Conditions

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Effluvium; Telogen

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

1 group of women with effluvium télogène

1 group of women without effluvium télogène
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Monocentric, Exploratory study, open, comparative, in parallel groups

Study Groups

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ET group

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

Group Type EXPERIMENTAL

Hair follicles sampling

Intervention Type OTHER

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

Control group

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

Group Type EXPERIMENTAL

Hair follicles sampling

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine SAINT MARTORY, MD

Role: PRINCIPAL_INVESTIGATOR

Unaffiliate

Locations

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Centre hospitalier Lyon Sud

Lyon, , France

Site Status

Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Nice, , France

Site Status

Centre de santé SABOURAUD

Paris, , France

Site Status

INTERTEK France

Paris, , France

Site Status

Centre de Recherche sur la Peau

Toulouse, , France

Site Status

Laboratoire Dermscan

Villeurbanne, , France

Site Status

Countries

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France

Other Identifiers

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STRESSCARBONYL1

Identifier Type: -

Identifier Source: org_study_id

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