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Demonstration of Carbonyl Stress on Hair Follicles

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ClinicalTrials.gov Identifier: NCT03414476
Recruitment Status : Not yet recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Dermo Cosmetique

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
Effluvium; Telogen Other: Hair follicles sampling Not Applicable

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  (Clinical Trial)
Estimated 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 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
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

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




Primary Outcome Measures :
  1. Biological evaluation [ Time Frame: 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 [ Time Frame: Visit 1- Day 1 ]
    Adverse events evaluation



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414476


Contacts
Contact: Fabienne CARBALLIDO +33562870171 fabienne.carballido@pierre-fabre.com
Contact: Adeline BACQUEY +33562877753 adeline.bacquey@pierre-fabre.com

Sponsors and Collaborators
Pierre Fabre Dermo Cosmetique
Investigators
Principal Investigator: Christine SAINT MARTORY, MD Unaffiliate

Responsible Party: Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier: NCT03414476     History of Changes
Other Study ID Numbers: STRESSCARBONYL1
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Proof of concept study, with confidential data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No