Telogen EffluviumNCT04237402
Demonstration of the Presence of a Carbonyl Stress in the Hair Follicles of Postpartum Women
A study testing Hair follicles sampling in people with Telogen Effluvium, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial 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. 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
- Telogen Effluvium
- What is being tested?
- Hair follicles sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2018to 16 Dec 2019
- 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:
- 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
Who cannot join
- 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)
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- 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:
- Treatment of general thyroid disorders initiated or modified for less than 3 months prior to inclusion (or change of specialty for less than 3 months)
- Systemic treatment affecting hair growth taken for at least 4 weeks during the 3 months prior to inclusion
- Systemic treatment: nonsteroidal anti-inflammatory drug, corticosteroid, antibiotic, antihistamine taken for 5 consecutive days within 2 weeks prior to inclusion or that may interfere with the results of the study according to the investigator,
- Dermal use, for at least 4 weeks, of Minoxidil, Aminexil within 3 months prior to inclusion
- Dermal use in the 4 weeks prior to inclusion, of any product that may be active on the hair follicle and scalp or may affect the dosage of carbonyl compounds (including hair dyes)
- Last shampoo less than 2 days before the inclusion and application of styling / care products (gel, lacquer, wax, conditioner ...) or water between the last shampoo and the inclusion
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
At the cutaneous level, oxidative stress induces the formation of carbonyl compounds which, by binding to proteins, produce non-functional adducts inducing cutaneous aging. This mechanism is called "carbonyl stress".
During pregnancy, estrogen increases massively, stimulates the whole body and prolongs the life of the hair (slower passage in telogen phase).
After delivery, estrogen levels drop, resulting in a massive and simultaneous hair loss that should have "naturally" fallen earlier. In addition, birth is a stressful stage for most moms. This stress and excessive fatigue and possibly a return to work may also be responsible for hair loss.
Is the carbonyl stress also present in the scalp and can it be one of the mechanisms involved in the occurrence of postpartum hair loss? To demonstrate this, samples of hair follicles are taken. The proteins are extracted from the samples and then assayed. The oxidized (carbonyl) proteins are labeled with specific fluorescent probes
- Conditions
- Telogen Effluvium
- 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Intra individual | Other | Before and after pregnancy, hair follicles will be analysed Receives: Other: Hair follicles sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of biological evaluation
Evaluation of the quantity of carbonyl compounds measured in the hair follicles taken before and after delivery.
Measured: 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
Adverse events evaluation for all subjects, all along the study
Measured: From inclusion to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start15 Jun 2018
- Primary completion6 Sep 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telogen EffluviumStudies 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
- Intervention model
- Sequential
- Model description
- 2 sampling timepoints: * before delivery * after delivery
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe VAYSSIERE, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237402
- Sponsor's protocol ID
- STRESSCARBONYL2
- Status last verified
- May 2020
- First submitted
- 1 Oct 2019
- Last updated
- 18 May 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 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the Presence of a Carbonyl Stress in the Hair Follicles of Postpartum Women
- ClinicalTrials.gov ID
- NCT04237402
- Acronym / sponsor ID
- STRESSCARBONYL2
- Conditions
- Telogen Effluvium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 23 Jan 2020 (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 postpartum women by comparing these compounds before and after delivery.
Detailed description
At the cutaneous level, oxidative stress induces the formation of carbonyl compounds which, by binding to proteins, produce non-functional adducts inducing cutaneous aging. This mechanism is called "carbonyl stress".
During pregnancy, estrogen increases massively, stimulates the whole body and prolongs the life of the hair (slower passage in telogen phase).
After delivery, estrogen levels drop, resulting in a massive and simultaneous hair loss that should have "naturally" fallen earlier. In addition, birth is a stressful stage for most moms. This stress and excessive fatigue and possibly a return to work may also be responsible for hair loss.
Is the carbonyl stress also present in the scalp and can it be one of the mechanisms involved in the occurrence of postpartum hair loss? To demonstrate this, samples of hair follicles are taken. 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 2 sampling timepoints: * before delivery * after delivery
| Arm | Type | Receives |
|---|---|---|
| Intra individual | Other | Other: Hair follicles samplingBefore and after pregnancy, hair follicles will be analysed |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
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 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. | Other | Intra individual |
Primary outcome
Change of biological evaluation
Time frame: 1st sample: inclusion visit (up to 8 weeks before delivery)- 2nd sample: end of study visit (10 to 16 weeks after delivery)
Evaluation of the quantity of carbonyl compounds measured in the hair follicles taken before and after delivery.
1 secondary outcome
Safety evaluation
Time frame: From inclusion to end of study
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 18 May 2020.
- Individual participant dataSharing planned: No. Proof of concept study, with confidential data
Related trials for Telogen Effluvium
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.
Christophe VAYSSIERE, MD principal investigator
1 site 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 Telogen Effluvium, run by Pierre Fabre Dermo Cosmetique at 1 site 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 6 inclusion and 20 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 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change of biological evaluation (time frame: 1st sample: inclusion visit (up to 8 weeks before delivery)- 2nd sample: end of study visit (10 to 16 weeks after delivery)). 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 18 May 2020.