Telogen EffluviumNCT04652232
Efficacy Study of Cosmetic Product Against Telogen Effluvium on Women
A study testing RV3466F lotion in people with Telogen Effluvium, run by Pierre Fabre Dermo Cosmetique at 2 sites in France.
Trial summary
Telogen effluvium (TE) is one of the most common causes of non-scarring diffuse hair loss, defined as global diminution of hair with no formation of areas completely bald. Premature termination of anagen into catagen and telogen hair follicle is the main mechanism observed in TE. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Telogen Effluvium
- What is being tested?
- RV3466F lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Dec 2016to 22 Jun 2017
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Criteria related to hair loss disorder:
- Subject having a proportion of hair in telogen phase superior to 15% (determined by phototrichogram at inclusion) on the centroparietal area of the scalp
- Subject having a total hair density superior or equal to ≥ 220 hairs/ cm2 (determined by phototrichogram at inclusion) on the centroparietal area of the scalp
- Non inclusion criteria :
- Criteria related to treatments and products:
- Any hair care product applied on the scalp between the selection visit and the inclusion visit (e.g. gel, hairspray, wax, foam, …) or water or brushing.
- Reaction to the used hair dye during the inclusion visit
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Randomized, Comparative Study to Assess the Effects of Cosmetic Lotion on Telogen Effluvium in Women Compared to a Control Group
Telogen effluvium (TE) is one of the most common causes of non-scarring diffuse hair loss, defined as global diminution of hair with no formation of areas completely bald.
Premature termination of anagen into catagen and telogen hair follicle is the main mechanism observed in TE. It results in increased, synchronized telogen shedding leading to a decrease in global hair density.
Read more
Acute telogen effluvium (ATE) has an abrupt onset and generalized scalp hair loss occurring 2-3 months after a triggering event, which could be unidentifiable in up to 33% cases.
The degree of effluvium depends on the severity, duration of exposure and the type of agent, that can be: emotional stress, hormonal changes in the postpartum period, high fever, surgery, surgical/accidental trauma, severe haemorrhage, chronic systemic illness, or immense psychological stress, changes in medication or crash-diets. A summer effect possibly ultraviolet (UV) light induced, manifesting itself in autumn can cause ATE. The incidence of TE is not known, although it is likely that most women will experience at least 1 episode of TE during a lifetime.
ATE can be diagnosed based on relevant medical and personal history and examination subjective complaints, clinical and physical exams or relevant investigations (hair pull test, phototrichogram, blood test…). ATE generates a lot of anxiety in the patient: significant impact on quality of life, self-esteem impairment, and stress increase. Thus, stress may act as a primary inducer; an aggravating factor or be a response to hair loss.
ATE usually remits within few months (3-4 to 6 months) in 95% of cases if the trigger is removed or treated. Complete recovery may take until 1 year. A resolving TE is characterized by the absence of hair shedding, a negative hair pull test and synchronized hair growth.
In this study, our aim is to assess the effects of the RV3466F lotion on hair growth, compared to a control group, with clinical and biometrological non- invasive methods on an adult female population with telogen effluvium.
Read the detailed description
In order to evaluate the interest of the RV3466F lotion in the remission of ET, which occurs naturally when the triggering cause is stopped, ,a comparative controlled group is necessary.
Moreover, due to the type of product (lotion) and the area of application ( scalp), the parallel groups design is adapted to the study purpose.
To increase the adherence to the study protocol and to limit the negative psychological impact of hair shedding without treatment, the control group receive a neutral shampoo (extra mild shampoo).
In order to avoid a bias between groups regarding the associated products, the same shampoo is given for the two groups. It should be used at the usual frequency. The allocation of the study product is randomized.
Only women are included in the study as specified in the claim of the study product.
The study area is the whole scalp. For evaluations the scalp is divided into 4 parts: centroparietal, parietal (right/left), frontal, and occipital areas The concerned part of the scalp which is evaluated can change according to the outcome measure.
The Phototrichogram (PTG) is a painless, non-invasive and objective method, used done in 2 steps 48 hours apart to provide an accurate chronological following of hair growth on a specific scalp area . All data and images are computerized, which enables a semi-automatic quantification of hair growth variables (density, growth…). A preliminary dyeing of the hair is performed, in order to enhance the contrast between hair and scalp.
The hair pull test is a semi quantitative method usually used to diagnose ongoing hair shedding and it helps to assess severity and location of hair loss.
Global photographs help to illustrate the scalp hair coverage and the overall course of hair volume. For a better standardization of the shooting conditions, a stereotactic device is used, allowing their comparison from time to time, which is done ideally by trained people, the photographs being subsequently time blinded.
The 60 seconds hair count test is a non-invasive and painless test performed by the subject itself, on the whole scalp in order to count the total number of hairs shed during a 60 seconds combing.
The clinical study includes 9 visits:
- Visit 1 - Selection (D1)
- Visit 2 - Inclusion - 48 hours (±2h) after V1
- Visit 3 - Intermediate - 4 weeks (D29 ± 4 days)
- Visit 4 -Intermediate - 48 hours (±2h) after V3
- Visit 5 - Intermediate - 8 weeks (D57 ± 4 days)
- Visit 6 - Intermediate - 48 hours (±2h) after V5
- Visit 7- Intermediate - 12 weeks (D85 ± 4 days)
- Visit 8 - Intermediate - 16 weeks (D113± 4 days)
- Visit 9 - Study end: 48 hours (±2h) after V8
The maximal duration of participation for a subject is 119 days.
- Conditions
- Telogen Effluvium
- Being tested
- RV3466F lotion, Shampoo
- Keywords
- hair shedding, visual efficacy, visual effect, phototrichogram, pull test, 60-s hair count test, globalphotographs, Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV3466F lotionOther
Code: RV3466F Formula: MF5354
Application modalities:
3 times per week, in the evening, on a dry scalp 10 sprays overall hair after having achieved hair rays in order that the product is in contact with the scalp. Then massage to promote penetration of the lotion. Don't rinse.
Shampoo should be avoided within the 2 hours after application
ShampooOther
Associated neutral shampoo: Extra mild shampoo Ducray® Code: RD0057H Formula: VS4031
Application modalities:
as often as usual
For the treated group only : no shampoo within the 2 hours after lotion application
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Active comparator | This group will receive the RV3466F lotion and a neutral shampoo Receives: Other: RV3466F lotion; Other: Shampoo |
| Control group | Other | This group will receive a neutral shampoo Receives: Other: Shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
anagen to telogen ratio
From phototrichogram on the centroparietal area of the scalp
Measured: Change from baseline to 16 weeks after application, for each group
Secondary outcomes (10)
anagen to telogen ratio
From phototrichogram on the centroparietal area of the scalp
Measured: 1 week, 4 weeks and 8 weeks after application, for each group
Density of telogen hair (number of hair in telogen phase/cm²)
From phototrichogram on the centroparietal area of the scalp
Measured: 1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group
Density of anagen hair (number of hair in anagen phase/cm²)
From phototrichogram on the centroparietal area of the scalp
Measured: 1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group
Total hair density (number of total hairs/cm²)
From phototrichogram on the centroparietal area of the scalp
Measured: 1 week; 4 weeks, 8 weeks and 16 weeks after application, for each group
Hair thickness
From phototrichogram on the centroparietal area of the scalp
Measured: 1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group
Cumulative hair thickness
From phototrichogram on the centroparietal area of the scalp
Measured: 1 week, 4 weeks, 8weeks and 16 weeks after application, for each group
Percentage of hairs pulled out
From the hair pull test on right and left bitemporal areas, frontal and occipital areas.
Measured: 1 week, 4 weeks, 8 weeks 12 weeks and 16 weeks after application, for each group
Total number of hairs shed
From the 60-s hair count test on the whole scalp
Measured: 4 weeks, 8 weeks 12 weeks and 16 weeks after application, for each group
Efficacy and cosmetic acceptability questionnaire
Self-assessment questionnaire filled by the subjects. Ad-hoc questionnaires including numerical scale from 0-10 where higher scores mean a better outcome (improvement)
Measured: 1 week; 4 weeks, 8 weeks and 16 weeks after application, for each group
Density assessment
From globalphotographs of the centroparietal area with a stereotactic device, blinded and assessed by experts using a 7-points scale: Important aggravation (less dense)=-3; Moderate aggravation=-2; Mild aggravation=-1; Unchanged=0; Mild improvement=1; Moderate improvement=2; Important improvement (denser)=3
Measured: 1 week and 16 weeks after application, for each group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start5 Dec 2016
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomisation list will be established. At the randomisation visit (Baseline visit 1), the Investigator will allocate a randomisation number to each subject according to the chronological order of inclusion. According to the list, the subject will be either randomized in one group of intervention. The investigator will only dispense the study product to the subjects included and randomized.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yorik Dr DROUAULT, Principal investigator, INTERTEK FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652232
- Sponsor's protocol ID
- RV3466F2016362
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Comparative Study to Assess the Effects of Cosmetic Lotion on Telogen Effluvium in Women Compared to a Control Group
- ClinicalTrials.gov ID
- NCT04652232
- Acronym / sponsor ID
- RV3466F2016362
- Conditions
- Telogen Effluvium
- Keywords
- hair shedding, visual efficacy, visual effect, phototrichogram, pull test, 60-s hair count test, globalphotographs, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 3 Dec 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.
Telogen effluvium (TE) is one of the most common causes of non-scarring diffuse hair loss, defined as global diminution of hair with no formation of areas completely bald.
Premature termination of anagen into catagen and telogen hair follicle is the main mechanism observed in TE. It results in increased, synchronized telogen shedding leading to a decrease in global hair density.
Acute telogen effluvium (ATE) has an abrupt onset and generalized scalp hair loss occurring 2-3 months after a triggering event, which could be unidentifiable in up to 33% cases.
The degree of effluvium depends on the severity, duration of exposure and the type of agent, that can be: emotional stress, hormonal changes in the postpartum period, high fever, surgery, surgical/accidental trauma, severe haemorrhage, chronic systemic illness, or immense psychological stress, changes in medication or crash-diets. A summer effect possibly ultraviolet (UV) light induced, manifesting itself in autumn can cause ATE. The incidence of TE is not known, although it is likely that most women will experience at least 1 episode of TE during a lifetime.
ATE can be diagnosed based on relevant medical and personal history and examination subjective complaints, clinical and physical exams or relevant investigations (hair pull test, phototrichogram, blood test…). ATE generates a lot of anxiety in the patient: significant impact on quality of life, self-esteem impairment, and stress increase. Thus, stress may act as a primary inducer; an aggravating factor or be a response to hair loss.
ATE usually remits within few months (3-4 to 6 months) in 95% of cases if the trigger is removed or treated. Complete recovery may take until 1 year. A resolving TE is characterized by the absence of hair shedding, a negative hair pull test and synchronized hair growth.
In this study, our aim is to assess the effects of the RV3466F lotion on hair growth, compared to a control group, with clinical and biometrological non- invasive methods on an adult female population with telogen effluvium.
Detailed description
In order to evaluate the interest of the RV3466F lotion in the remission of ET, which occurs naturally when the triggering cause is stopped, ,a comparative controlled group is necessary.
Moreover, due to the type of product (lotion) and the area of application ( scalp), the parallel groups design is adapted to the study purpose.
To increase the adherence to the study protocol and to limit the negative psychological impact of hair shedding without treatment, the control group receive a neutral shampoo (extra mild shampoo).
In order to avoid a bias between groups regarding the associated products, the same shampoo is given for the two groups. It should be used at the usual frequency. The allocation of the study product is randomized.
Only women are included in the study as specified in the claim of the study product.
The study area is the whole scalp. For evaluations the scalp is divided into 4 parts: centroparietal, parietal (right/left), frontal, and occipital areas The concerned part of the scalp which is evaluated can change according to the outcome measure.
The Phototrichogram (PTG) is a painless, non-invasive and objective method, used done in 2 steps 48 hours apart to provide an accurate chronological following of hair growth on a specific scalp area . All data and images are computerized, which enables a semi-automatic quantification of hair growth variables (density, growth…). A preliminary dyeing of the hair is performed, in order to enhance the contrast between hair and scalp.
The hair pull test is a semi quantitative method usually used to diagnose ongoing hair shedding and it helps to assess severity and location of hair loss.
Global photographs help to illustrate the scalp hair coverage and the overall course of hair volume. For a better standardization of the shooting conditions, a stereotactic device is used, allowing their comparison from time to time, which is done ideally by trained people, the photographs being subsequently time blinded.
The 60 seconds hair count test is a non-invasive and painless test performed by the subject itself, on the whole scalp in order to count the total number of hairs shed during a 60 seconds combing.
The clinical study includes 9 visits:
- Visit 1 - Selection (D1)
- Visit 2 - Inclusion - 48 hours (±2h) after V1
- Visit 3 - Intermediate - 4 weeks (D29 ± 4 days)
- Visit 4 -Intermediate - 48 hours (±2h) after V3
- Visit 5 - Intermediate - 8 weeks (D57 ± 4 days)
- Visit 6 - Intermediate - 48 hours (±2h) after V5
- Visit 7- Intermediate - 12 weeks (D85 ± 4 days)
- Visit 8 - Intermediate - 16 weeks (D113± 4 days)
- Visit 9 - Study end: 48 hours (±2h) after V8
The maximal duration of participation for a subject is 119 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomisation list will be established. At the randomisation visit (Baseline visit 1), the Investigator will allocate a randomisation number to each subject according to the chronological order of inclusion. According to the list, the subject will be either randomized in one group of intervention. The investigator will only dispense the study product to the subjects included and randomized.
| Arm | Type | Receives |
|---|---|---|
| Treated group | Active comparator | Other: RV3466F lotion, Other: ShampooThis group will receive the RV3466F lotion and a neutral shampoo |
| Control group | Other | Other: ShampooThis group will receive a neutral shampoo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Criteria related to hair loss disorder:
- Subject having a proportion of hair in telogen phase superior to 15% (determined by phototrichogram at inclusion) on the centroparietal area of the scalp
- Subject having a total hair density superior or equal to ≥ 220 hairs/ cm2 (determined by phototrichogram at inclusion) on the centroparietal area of the scalp
- Criteria related to treatments and products:
- Any hair care product applied on the scalp between the selection visit and the inclusion visit (e.g. gel, hairspray, wax, foam, …) or water or brushing.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RV3466F lotionCode: RV3466F Formula: MF5354 Application modalities: 3 times per week, in the evening, on a dry scalp 10 sprays overall hair after having achieved hair rays in order that the product is in contact with the scalp. Then massage to promote penetration of the lotion. Don't rinse. Shampoo should be avoided within the 2 hours after application | Other | Treated group |
| ShampooAssociated neutral shampoo: Extra mild shampoo Ducray® Code: RD0057H Formula: VS4031 Application modalities: as often as usual For the treated group only : no shampoo within the 2 hours after lotion application | Other | Control group, Treated group |
Primary outcome
anagen to telogen ratio
Time frame: Change from baseline to 16 weeks after application, for each group
From phototrichogram on the centroparietal area of the scalp
10 secondary outcomes
anagen to telogen ratio
Time frame: 1 week, 4 weeks and 8 weeks after application, for each group
Density of telogen hair (number of hair in telogen phase/cm²)
Time frame: 1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group
Density of anagen hair (number of hair in anagen phase/cm²)
Time frame: 1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group
Total hair density (number of total hairs/cm²)
Time frame: 1 week; 4 weeks, 8 weeks and 16 weeks after application, for each group
Hair thickness
Time frame: 1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group
Cumulative hair thickness
Time frame: 1 week, 4 weeks, 8weeks and 16 weeks after application, for each group
Percentage of hairs pulled out
Time frame: 1 week, 4 weeks, 8 weeks 12 weeks and 16 weeks after application, for each group
Total number of hairs shed
Time frame: 4 weeks, 8 weeks 12 weeks and 16 weeks after application, for each group
Efficacy and cosmetic acceptability questionnaire
Time frame: 1 week; 4 weeks, 8 weeks and 16 weeks after application, for each group
Density assessment
Time frame: 1 week and 16 weeks after application, for each group
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 3 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Yorik Dr DROUAULT principal investigator
INTERTEK FRANCE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RV3466F lotion in people with Telogen Effluvium, run by Pierre Fabre Dermo Cosmetique at 2 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 7 inclusion and 0 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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
anagen to telogen ratio (time frame: Change from baseline to 16 weeks after application, for each group). 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 3 Dec 2020.