Efficacy Study of Cosmetic Product Against Telogen Effluvium on Women

NCT ID: NCT04652232

Last Updated: 2020-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-05
• Study Completion Date: 2017-06-22

Brief 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.

Conditions

Telogen Effluvium

Keywords

hair shedding; visual efficacy; visual effect; phototrichogram; pull test; 60-s hair count test; globalphotographs; Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treated group

This group will receive the RV3466F lotion and a neutral shampoo

Group Type: ACTIVE_COMPARATOR

RV3466F lotion

Intervention Type: 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

Shampoo

Intervention Type: 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

Control group

This group will receive a neutral shampoo

Group Type: OTHER

Shampoo

Intervention Type: 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

Interventions

RV3466F lotion

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

Intervention Type: OTHER

Shampoo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.
• Reaction to the used hair dye during the inclusion visit

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yorik Dr DROUAULT

Role: PRINCIPAL_INVESTIGATOR

INTERTEK FRANCE

Locations

Centre de santé SABOURAUD C.E.P.C

Paris, , France

INTERTEK

Paris, , France

Countries

France

Other Identifiers

RV3466F2016362

Identifier Type: -

Identifier Source: org_study_id