Efficacy Study of Cosmetic Product Against Telogen Effluvium on Women

NCT04652232 | Completed

• 1 other identifier: RV3466F2016362
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Telogen Effluvium

Keywords

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

Outcome Measures

Primary Outcomes (1)

• anagen to telogen ratio

  From phototrichogram on the centroparietal area of the scalp

  Change from baseline to 16 weeks after application, for each group

Secondary Outcomes (10)

• anagen to telogen ratio

  1 week, 4 weeks and 8 weeks after application, for each group

• Density of telogen hair (number of hair in telogen phase/cm²)

  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)

  1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group

• Total hair density (number of total hairs/cm²)

  1 week; 4 weeks, 8 weeks and 16 weeks after application, for each group

• Hair thickness

  1 week, 4 weeks, 8 weeks and 16 weeks after application, for each group

Study Arms (2)

Treated group

ACTIVE COMPARATOR

This group will receive the RV3466F lotion and a neutral shampoo

Other: RV3466F lotion; Other: Shampoo

Control group

OTHER

This group will receive a neutral shampoo

Other: Shampoo

Interventions

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

Treated group

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

Control group; Treated group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Criteria related to hair loss disorder:
• Criteria related to treatments and products:

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (2)

Centre de santé SABOURAUD C.E.P.C

Paris, France

Location

INTERTEK

Paris, France

Location

MeSH Terms

Interventions

A 200 pyrinate shampoo

Study Officials

• Yorik Dr DROUAULT

  INTERTEK FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 3, 2020
• Study Start: December 5, 2016
• Primary Completion: June 22, 2017
• Study Completion: June 22, 2017
• Last Updated: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)