Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576492
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Assessment of the Effects and Tolerance of the RV4986A Lotion in Men With AGA After Hair Transplant
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of the Effects and Tolerance of the RV4986A Lotion in Men With AGA After Hair Transplant Controlled and Randomized Open Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None