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Completed

NCT Number: NCT03414476

Demonstration of Carbonyl Stress on Hair Follicles

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 ...).

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier Lyon Sud, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hair follicles sampling

Other

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

Primary outcomes

  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 outcomes

  1. Safety evaluation

    Time frame: Visit 1- Day 1

    Adverse events evaluation

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

Demonstration of the Presence of Carbonyl Stress in the Hair Follicles of Women With Reactive Hair Loss

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2018
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.