Effluvium; TelogenNCT03414476
Demonstration of Carbonyl Stress on Hair Follicles
A study testing Hair follicles sampling in people with Effluvium; Telogen, run by Pierre Fabre Dermo Cosmetique at 6 sites in France.
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 ...). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effluvium; Telogen
- What is being tested?
- Hair follicles sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesFrance
- Study dates
- 26 Mar 2018to 25 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre hospitalier Lyon Sud
Lyon, 69007
Centre de Pharmacologie Clinique Appliquée à la Dermatologie
Nice, 06202
Centre de santé SABOURAUD
Paris, 75010
INTERTEK France
Paris, 75013
Centre de Recherche sur la Peau
Toulouse, 31025
Laboratoire Dermscan
Villeurbanne, 69100
About this study
Official title: Demonstration of the Presence of Carbonyl Stress in the Hair Follicles of Women With Reactive Hair Loss
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 ...).
Read the 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.
- Conditions
- Effluvium; Telogen
- Being tested
- Hair follicles sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair follicles samplingOther
The follicles will be collected by lock of 10 hair on the scalp (centro-parietal part), to obtain 40 follicles with epithelial sheath
| Study group | Role | What they receive |
|---|---|---|
| ET group | Experimental | Sampling : Hair follicles sampling on the scalp in women with Telogene Effluvium Receives: Other: Hair follicles sampling |
| Control group | Experimental | Sampling: Hair follicles sampling on the scalp in women without Telogene Effluvium Receives: Other: Hair follicles sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological evaluation
Evaluation of the quantity of carbonyl compounds measured in the hair follicles taken from the two groups.
Measured: Visit 1- Day 1
Secondary outcomes (1)
Safety evaluation
Adverse events evaluation
Measured: Visit 1- Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start26 Mar 2018
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effluvium; TelogenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1 group of women with effluvium télogène 1 group of women without effluvium télogène
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine SAINT MARTORY, MD, Principal investigator, Unaffiliate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414476
- Sponsor's protocol ID
- STRESSCARBONYL1
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2018
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Proof of concept study, with confidential data
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the Presence of Carbonyl Stress in the Hair Follicles of Women With Reactive Hair Loss
- ClinicalTrials.gov ID
- NCT03414476
- Acronym / sponsor ID
- STRESSCARBONYL1
- Conditions
- Effluvium; Telogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ...).
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 group of women with effluvium télogène 1 group of women without effluvium télogène
| Arm | Type | Receives |
|---|---|---|
| ET group | Experimental | Other: Hair follicles samplingSampling : Hair follicles sampling on the scalp in women with Telogene Effluvium |
| Control group | Experimental | Other: Hair follicles samplingSampling: Hair follicles sampling on the scalp in women without Telogene Effluvium |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- Menopause
- Pregnancy, breastfeeding, childbirth for less than 6 months
- Alopecia causing hair loss on the upper part of the scalp
- Dermatological pathology or evolving cutaneous lesion in the scalp
- Control group only:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hair follicles samplingThe follicles will be collected by lock of 10 hair on the scalp (centro-parietal part), to obtain 40 follicles with epithelial sheath | Other | Control group, ET group |
Primary outcome
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.
1 secondary outcome
Safety evaluation
Time frame: Visit 1- Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Individual participant dataSharing planned: No. Proof of concept study, with confidential data
Related trials for Effluvium; Telogen
Not yet recruitingObservational study
Gut Microbiota and Trichoscopic Changes in Women With Telogen Effluvium on a Multifactorial Drinkable Nutraceutical: A Retrospective Observational Study
Gut Dysbiosis, Telogen Effluvium
Recruiting
Efficacy and Safety of a Drinkable Nutraceutical for Hair Loss in Patients Using GLP-1/GIP Receptor Agonists
Telogen Effluvium
Not yet recruiting
Evaluation of the Dietary Supplement Effect on Improvement of Hair Condition in Subjects With Occasional Hair Loss.
Occasional Hair Loss
Not yet recruiting
Dietary Supplement for Telogen Effluvium Associated With GLP-1 Receptor Agonist Use
Alopecia
Not yet recruitingPhase 2/3
Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
Telogen Effluvium, Female Pattern Hair Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine SAINT MARTORY, MD principal investigator
Unaffiliate
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hair follicles sampling in people with Effluvium; Telogen, run by Pierre Fabre Dermo Cosmetique at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological evaluation (time frame: Visit 1- Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.