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Assessment of the Effects and Tolerance of the RV4986A Lotion in Men With AGA After Hair Transplant

NCT06576492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-28

No results posted yet for this study

Summary

Alopecia involves a diminution of visible hair that can have significant psychosocial effects and impairment of quality of life. There are numerous types of alopecia, among them, androgenic alopecia (AGA) is the most common form surgically treatable.

Androgenic alopecia is characterized by progressive visible thinning of scalp hair in genetically susceptible men (MAGA, or male pattern androgenic alopecia) and in some women (FPHL, or female pattern hair loss).

Among the plethora of products available proposed to promote hair growth in the scalp, only 2 medications are approved by the US Food and Drug Administration (FDA). These medications are finasteride (systemic) and minoxidil (topical).

In some cases, limited perceived efficacy of these treatments, poor tolerance, fear and lack of information on treatment duration and possible adverse events may lead to premature stop of treatment, disappointment and influence on patient compliance.

When conventional treatments have proven to be deceptive, a surgical treatment can be considered: hair transplant, that has evolved mainly with the aim of making the results look more and more natural.

Hair transplant, although performed on an outpatient basis, is an invasive technique, with the following immediate side effects: pain, pruritus, inflammation, scabs, swollen eyelids with tearing which last about 15 days. A social exclusion for 15 days after the transplant is generally necessary. For 1 to 2 months, the Red Scalp syndrome or inflammatory scalp is observed.

The growth of transplanted hair starts from the 6th month and the expected result is not really achieved until one year.

The product RV4986A is a non-rinsed cosmetic lotion intended to be used every day on the entire scalp especially in case of hormonal or hereditary chronic hair loss (as AGA) and also before hair transplant in order to prepare hair scalp and after hair transplant in order to soothe the scalp.

To date, no consensus and guidelines for pre- and post-transplant management exist regarding cosmetic products to apply that could limit their transplant side effects in time and intensity.

The aim of the study is to assess the effect of a new product (topical lotion) developed as an adjuvant product pre- and post-transplant that prepares hair scalp before the transplant and soothes it after hair transplant.

Conditions

  • Androgenic Alopecia

Interventions

OTHER

RV4986A lotion

* Application between Month -0.5 and Month 0 (before hair transplant): once a day on the entire scalp * From 4 days after hair transplant and until Visit 4 (Month 0,5 post transplant): once a day on the recipient area * Between Month 0.5 and Month 12: once a day on the entire scalp

OTHER

RD0057H shampoo

* Application between Month -0.5 and Month 0 (before hair transplant): at usual frequency when required on the entire scalp * From 2nd day after hair transplant and until the 7th day after hair transplant: application on the recipient area with a spray containing mixture of water and shampoo. For the rest of the head application with the same modalities than before hair transplant * From the 8th day after hair transplant to the 15th day: application with a sponge on the recipient area * From the 16th day after hair transplant and for the next 12th months: application with the same modalities than before hair transplant

Sponsors & Collaborators

  • Pierre Fabre Dermo Cosmetique

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2023-06-12
Completion
2023-06-12

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06576492 on ClinicalTrials.gov