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

NCT04237402 | Completed

• 1 other identifier: STRESSCARBONYL2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Telogen Effluvium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety evaluation

  From inclusion to end of study

Study Arms (1)

Intra individual

OTHER

Before and after pregnancy, hair follicles will be analysed

Other: Hair follicles sampling

Interventions

Hair follicles sampling OTHER

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.

Intra individual

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Hôpital Purpan

Toulouse, 31059, France

Location

Study Officials

• Christophe VAYSSIERE, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 sampling timepoints: * before delivery * after delivery

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: January 23, 2020
• Study Start: June 15, 2018
• Primary Completion: September 6, 2019
• Study Completion: December 16, 2019
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)