Efficacy Study of Cosmetic Product Against Telogen Effluvium on Women
Condition: Telogen Effluvium
MeSH terms: Alopecia Areata
Study type: Interventional

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. 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.
    

Intervention name(s): RV3466F lotion; Shampoo
Intervention type(s): Other; Other
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Supportive Care
Keywords: hair shedding; visual efficacy; visual effect; phototrichogram; pull test; 60-s hair count test; globalphotographs; Women