Demonstration of Carbonyl Stress on Hair Follicles

Effluvium; Telogen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414476
• Other study ID #: STRESSCARBONYL1
• Status: Completed
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: June 25, 2018

Study information

• Verified date: January 2018
• Source: Pierre Fabre Dermo Cosmetique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ...).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Effluvium; Telogen

Intervention

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

Locations

Country	Name	City	State
France	Centre hospitalier Lyon Sud	Lyon
France	Centre de Pharmacologie Clinique Appliquée à la Dermatologie	Nice
France	Centre de santé SABOURAUD	Paris
France	INTERTEK France	Paris
France	Centre de Recherche sur la Peau	Toulouse
France	Laboratoire Dermscan	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Dermo Cosmetique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological evaluation	Evaluation of the quantity of carbonyl compounds measured in the hair follicles taken from the two groups.	Visit 1- Day 1
Secondary	Safety evaluation	Adverse events evaluation	Visit 1- Day 1