Demonstration of Carbonyl Stress on Hair Follicles

• ClinicalTrials.gov Identifier: NCT03414476
• Recruitment Status: Completed
• First Posted: January 30, 2018
• Last Update Posted: January 21, 2020
• Sponsor: Pierre Fabre Dermo Cosmetique
• Information provided by (Responsible Party): Pierre Fabre Dermo Cosmetique

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Study Start Date: March 26, 2018
• Actual Primary Completion Date: June 25, 2018
• Actual Study Completion Date: June 25, 2018

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

Centre hospitalier Lyon Sud

Lyon, France, 69007

Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Nice, France, 06202

Centre de santé SABOURAUD

Paris, France, 75010

INTERTEK France

Paris, France, 75013

Centre de Recherche sur la Peau

Toulouse, France, 31025

Laboratoire Dermscan

Villeurbanne, France, 69100

Sponsors and Collaborators

Pierre Fabre Dermo Cosmetique

Investigators

• Principal Investigator: Christine SAINT MARTORY, MD; Unaffiliate

More Information

• Responsible Party: Pierre Fabre Dermo Cosmetique
• ClinicalTrials.gov Identifier: NCT03414476
• Other Study ID Numbers: STRESSCARBONYL1
• First Posted: January 30, 2018
• Last Update Posted: January 21, 2020
• 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