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

NCT06576492 | Completed

• 1 other identifier: RV4986A20200299
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenic Alopecia

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (2)

Treated group

EXPERIMENTAL

Application of RV4986A lotion associated with RD0057H shampoo (Extra Doux shampoo)

Other: RV4986A lotion; Other: RD0057H shampoo

Control group

OTHER

Application of RD0057H shampoo (Extra Doux shampoo)

Other: RD0057H shampoo

Interventions

RV4986A lotion OTHER

* 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

Treated group

RD0057H shampoo OTHER

* 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

Control group; Treated group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Subject requiring hair transplant with micrografts (strip technique or FUE technique)
• Subject aged ≥ 18 years old
• Subject having androgenetic alopecia selected by the investigator for a hair transplant
• Subject having any other hair disorder or hair disease (telogen effluvium, alopecia areata, cicatricial alopecia, hair shaft disorder, trichotillomania…) and liable to interfere with the study assessments
• Subject having dermatological pathology or evolutive skin lesion on the scalp (psoriasis, seborrheic dermatitis, severe erythema, severe excoriation, severe sunburn, …)
• Iron deficiency (confirmation by ferritin assay results from less than 3 months performed during preoperative assessment)
• Thyroid disorders (confirmation by thyroid hormon assay results from less than 3 months performed during preoperative assessment)

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Instituto Medico Ricart

Madrid, Chamartin, 28046, Spain

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 28, 2024
• Study Start: July 5, 2021
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)