Demonstration of the Presence of a Carbonyl Stress in the Hair Follicles of Postpartum Women

In this study, the investigator will try to highlight the presence of carbonyl compounds in the hair follicles of postpartum women by comparing these compounds before and after delivery.

Study Overview

• Status: Completed
• Conditions: Telogen Effluvium
• 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 non-functional adducts inducing cutaneous aging. This mechanism is called "carbonyl stress".

During pregnancy, estrogen increases massively, stimulates the whole body and prolongs the life of the hair (slower passage in telogen phase).

After delivery, estrogen levels drop, resulting in a massive and simultaneous hair loss that should have "naturally" fallen earlier. In addition, birth is a stressful stage for most moms. This stress and excessive fatigue and possibly a return to work may also be responsible for hair loss.

Is the carbonyl stress also present in the scalp and can it be one of the mechanisms involved in the occurrence of postpartum hair loss? To demonstrate this, samples of hair follicles are taken. 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): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Hopital Purpan

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:

• Pregnant woman (≥ 33 weeks of amenorrhea)
• Woman aged between 18 and 40 years (included)
• Phototype I to IV included according to Fitzpatrick's classification
• Affiliation to a French social security scheme or benefiting from such a scheme
• Signed informed consent form

Exclusion Criteria:

Criteria related to the Population:

• High risk or pathological pregnancy, according to the opinion of the investigator
• Deprivation of liberty by administrative or judicial decision or subject under guardianship
• Impossibility, according to the investigator, to comply with the requirements of the protocol
• Linguistic or psychic incapacity to sign informed consent
• Concomitant participation in a clinical study that may interfere with the results of the study, according to the opinion of the investigator (excluding observational studies)

Criteria related to Pathology :

• Alopecia causing hair loss on the upper part of the scalp
• Dermatological pathology or evolving cutaneous lesion in the scalp
• Known history of hepatitis B and C, HIV
• Past or present neoplastic condition
• Acute evolving pathology
• Gestational diabetes treated with insulin

Criteria related to Treatments:

• Treatment of general thyroid disorders initiated or modified for less than 3 months prior to inclusion (or change of specialty for less than 3 months)
• Systemic treatment affecting hair growth taken for at least 4 weeks during the 3 months prior to inclusion
• Systemic treatment: nonsteroidal anti-inflammatory drug, corticosteroid, antibiotic, antihistamine taken for 5 consecutive days within 2 weeks prior to inclusion or that may interfere with the results of the study according to the investigator,
• Dermal use, for at least 4 weeks, of Minoxidil, Aminexil within 3 months prior to inclusion
• Dermal use in the 4 weeks prior to inclusion, of any product that may be active on the hair follicle and scalp or may affect the dosage of carbonyl compounds (including hair dyes)
• Last shampoo less than 2 days before the inclusion and application of styling / care products (gel, lacquer, wax, conditioner ...) or water between the last shampoo and the inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intra individual; Before and after pregnancy, hair follicles will be analysed	Other: Hair follicles sampling; The hair follicles will be collected by strand of 5 to 6 hairs approximately in the scalp (centro-parietal part), in order to obtain 20 follicles with epithelial sheath.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of biological evaluation	Evaluation of the quantity of carbonyl compounds measured in the hair follicles taken before and after delivery.	1st sample: inclusion visit (up to 8 weeks before delivery)- 2nd sample: end of study visit (10 to 16 weeks after delivery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	Adverse events evaluation for all subjects, all along the study	From inclusion to end of study

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Principal Investigator: Christophe VAYSSIERE, MD

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): September 6, 2019
• Study Completion (Actual): December 16, 2019

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STRESSCARBONYL2

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