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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.
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:
The maximal duration of participation for a subject is 119 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group | Active Comparator | This group will receive the RV3466F lotion and a neutral shampoo |
|
| Control group | Other | This group will receive a neutral shampoo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV3466F lotion | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| anagen to telogen ratio | From phototrichogram on the centroparietal area of the scalp | Change from baseline to 16 weeks after application, for each group |
| Measure | Description | Time Frame |
|---|---|---|
| anagen to telogen ratio | From phototrichogram on the centroparietal area of the scalp | 1 week, 4 weeks and 8 weeks after application, for each group |
| Density of telogen hair (number of hair in telogen phase/cm²) |
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Selection criteria :
Criteria related to the population:
Criteria related to diseases and hair loss disorder:
- Subject having effluvium telogen
Non selection criteria :
Criteria related to the population:
Criteria related to diseases and hair loss disorders:
- Subject who has any other hair disorder or hair disease (Ludwig II, III, AA, scarring alopecia …)
Criteria related to the population:
Criteria related to diseases and hair loss disorders:
Criteria related to treatments and products:
Inclusion criteria :
Non inclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Yorik Dr DROUAULT | INTERTEK FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de santé SABOURAUD C.E.P.C | Paris | France | ||||
| INTERTEK |
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| ID | Term |
|---|---|
| C050604 | A 200 pyrinate shampoo |
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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.
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| Shampoo | Other | 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 |
|
From phototrichogram on the centroparietal area of the scalp
| 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 | 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 | 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 | 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 | 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. | 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 | 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) | 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 | 1 week and 16 weeks after application, for each group |
| Paris |
| France |