Assessment of the Effects and Tolerance of the RV4986A Lotion in Men With AGA After Hair Transplant
NCT Number: NCT06576492
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Androgenic Alopecia
Interventions: OTHER: RV4986A lotion|OTHER: RD0057H shampoo
Sponsor: Pierre Fabre Dermo Cosmetique
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-07-05
Completion Date: 2023-06-12
Locations: Instituto Medico Ricart, Madrid, Chamartin, 28046, Spain

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.

Primary Outcome Measures: Evaluate the effects of the RV4986A lotion on hair and scalp for the first 12 months after hair transplant compared to a control group by global aspect of the scalp, assessed in vivo by the investigator, on the recipient area (frontal and/or vertex areas) on 5-point scale, Months 0.5, 1, 3, 6, 9 and 12 compared to Month 0 (hair transplant)|Evaluate the effects of the RV4986A lotion on hair and scalp for the first 12 months after hair transplant compared to a control group by hair growth, assessed in vivo by the investigator, on the recipient area on 5-point scale, Months 6, 9, 12 compared to Month 0 (hair transplant)|Evaluate the effects of the RV4986A lotion on hair and scalp for the first 12 months after hair transplant compared to a control group by aspect of the scalp, assessed from standardised photographs, rated by several investigators (or trained people) on blinded groups, on the recipient area on 11-point scale, Months 0, 0.5, 6, 9, 12 compared to Month -0.5 (inclusion, pre-hair transplant)|Evaluate the effects of the RV4986A lotion on hair and scalp for the first 12 months after hair transplant compared to a control group by aspect of the hair, assessed from standardised photographs, rated by several investigators (or trained people) on blinded groups, on the recipient area on 11-point scale, Months 0, 0.5, 6, 9, 12 compared to Month -0.5 (inclusion, pre-hair transplant)|Evaluate the effects of the RV4986A lotion on hair and scalp for the first 12 months after hair transplant compared to a control group by Scalp soothing and cosmetic recovery (erythema and scalp oedema evaluation), Physical signs erythema and scalp oedema scoring (in vivo assessments of) on 11-point scale, Months 0 and 0.5|Evaluate the effects of the RV4986A lotion on hair and scalp for the first 12 months after hair transplant compared to a control group by Scalp soothing and cosmetic recovery (crusts and healing evaluation), Physical signs crusts and healing scoring (in vivo assessments of) on 11-point scale, Months 0, 0.5, 1 and 3|Evaluate the effects of the RV4986A lotion on hair and scalp for the first 12 months after hair transplant compared to a control group by Scalp soothing and cosmetic recovery, Visual evaluation by Trichoscopy of crusts and erythema, Months 0 and 0.5|Evaluate the effects of the RV4986A lotion on hair and scalp for the first 12 months after hair transplant compared to a control group by Global efficacy (PGA = patient global assessment), assessed by the subject on the recipient area, according to a 5-point scale, Months 0, 0.5, 1, 3, 6, 9 and 12 and monthly between each visit|Evaluate the effects of the RV4986A lotion on hair and scalp for the first 12 months after hair transplant compared to a control group by Functional signs, assessed by the subject on the recipient area, according to a 11-point scale, At each visit from Month 0 (hair transplant)|Evaluate the effects of the RV4986A lotion on hair and scalp for the first 12 months after hair transplant compared to a control group by Satisfaction & Cosmetic acceptability & Quality of Life & Hair/Scalp perception assessments, assessed by the subject with subject's questionnaire, Months 0, 1, 6 and 12|Evaluate the tolerance of the products for 12 months of use by adverse events, Adverse events, At each visit from Month 0 to Month 12|Evaluate the tolerance of the products for 12 months of use by physical and functional signs, assessed by the investigator for physical signs and by the subject for functional signs on the entire scalp (before hair transplant) or recipient area (after hair transplant), according to a 11-point scale, At each visit from Month 0 to Month 12|Evaluate the tolerance of the products for 12 months of use by global tolerance per subject, assessed by the investigator for both groups and per subject, considering all individual AE and their characteristics, based on a 5-point scale, at Month 0 (for period of pre-transplant) and at Month 12 (end of the study)|Evaluate the subject's compliance regarding the test product, The subject will report his compliance in a subject's diary.

Compliance will be monitored by weighing tubes. Test products will be weighed at the beginning and the end of the study under sponsor responsibility according a validated weighing protocol, At each visit from Month 0 to Month 12