Clincosm LogoSign in Get a demo

Demonstration of Carbonyl Stress on Hair Follicles

Sponsor
Pierre Fabre Dermo Cosmetique (Industry)
Overall Status
Completed
CT.gov ID
NCT03414476
Collaborator
(none)
40
Enrollment
6
Locations
2
Arms
3
Actual Duration (Months)
6.7
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

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 ...).

Condition or Disease Intervention/Treatment Phase
  • Other: Hair follicles sampling
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1 group of women with effluvium télogène 1 group of women without effluvium télogène1 group of women with effluvium télogène 1 group of women without effluvium télogène
Masking:
None (Open Label)
Masking Description:
Monocentric, Exploratory study, open, comparative, in parallel groups
Primary Purpose:
Basic Science
Official Title:
Demonstration of the Presence of Carbonyl Stress in the Hair Follicles of Women With Reactive Hair Loss
Actual Study Start Date :
Mar 26, 2018
Actual Primary Completion Date :
Jun 25, 2018
Actual Study Completion Date :
Jun 25, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Biological evaluation [Visit 1- Day 1]

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

Secondary Outcome Measures

  1. Safety evaluation [Visit 1- Day 1]

    Adverse events evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre hospitalier Lyon Sud Lyon France 69007
2 Centre de Pharmacologie Clinique Appliquée à la Dermatologie Nice France 06202
3 Centre de santé SABOURAUD Paris France 75010
4 INTERTEK France Paris France 75013
5 Centre de Recherche sur la Peau Toulouse France 31025
6 Laboratoire Dermscan Villeurbanne France 69100

Sponsors and Collaborators

  • Pierre Fabre Dermo Cosmetique

Investigators

  • Principal Investigator: Christine SAINT MARTORY, MD, Unaffiliate

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier:
NCT03414476
Other Study ID Numbers:
  • STRESSCARBONYL1
First Posted:
Jan 30, 2018
Last Update Posted:
Jan 21, 2020
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 21, 2020