Androgenic AlopeciaNCT06576492
Assessment of the Effects and Tolerance of the RV4986A Lotion in Men With AGA After Hair Transplant
A study testing RV4986A lotion in people with Androgenic Alopecia, run by Pierre Fabre Dermo Cosmetique at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- RV4986A lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jul 2021to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Main inclusion criteria:
- 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
Main non-inclusion criteria:
- 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)
- Systemic treatment with antithyroid or iron supplement established or modified within 3 months before the inclusion or planned during the study
- Radiotherapy or chemotherapy at any time before the inclusion or planned during the study
- Systemic anti-hair loss treatment (anti-androgenic treatments…) established or modified within 6 months before the inclusion visit or planned during the study
- Topical anti-hair loss treatment (Minoxidil…) established or modified within 3 months before the inclusion visit or planned during the study
- Any other systemic treatment (cardiovascular, endocrine, antidepressant, antipsychotic, …) established or modified during the previous weeks before the inclusion or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the products according to the investigator's assessment
- Any other topical treatment or product applied on the scalp within previous weeks before the inclusion or planned during the study that can limit the effectiveness of the transplant and liable to interfere with the study assessments, according to the investigator's opinion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effects and Tolerance of the RV4986A Lotion in Men With AGA After Hair Transplant: Controlled and Randomized Open Study
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).
Read more
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
- Being tested
- RV4986A lotion, RD0057H shampoo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV4986A lotionOther
- 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
RD0057H shampooOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Experimental | Application of RV4986A lotion associated with RD0057H shampoo (Extra Doux shampoo) Receives: Other: RV4986A lotion; Other: RD0057H shampoo |
| Control group | Other | Application of RD0057H shampoo (Extra Doux shampoo) Receives: Other: RD0057H shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Months 0, 1, 6 and 12
Evaluate the tolerance of the products for 12 months of use by adverse events
Adverse events
Measured: 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
Measured: 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
Measured: 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
Measured: At each visit from Month 0 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start5 Jul 2021
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576492
- Sponsor's protocol ID
- RV4986A20200299
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects and Tolerance of the RV4986A Lotion in Men With AGA After Hair Transplant: Controlled and Randomized Open Study
- ClinicalTrials.gov ID
- NCT06576492
- Acronym / sponsor ID
- RV4986A20200299
- Conditions
- Androgenic Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | Experimental | Other: RV4986A lotion, Other: RD0057H shampooApplication of RV4986A lotion associated with RD0057H shampoo (Extra Doux shampoo) |
| Control group | Other | Other: RD0057H shampooApplication of RD0057H shampoo (Extra Doux shampoo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Treated group |
| 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 | Other | Control group, Treated group |
Primary outcome
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
Time frame: Months 0.5, 1, 3, 6, 9 and 12 compared to Month 0 (hair transplant)
assessed in vivo by the investigator, on the recipient area (frontal and/or vertex areas) on 5-point scale
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
Time frame: Months 6, 9, 12 compared to Month 0 (hair transplant)
assessed in vivo by the investigator, on the recipient area on 5-point scale
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
Time frame: Months 0, 0.5, 6, 9, 12 compared to Month -0.5 (inclusion, pre-hair transplant)
assessed from standardised photographs, rated by several investigators (or trained people) on blinded groups, on the recipient area on 11-point scale
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
Time frame: Months 0, 0.5, 6, 9, 12 compared to Month -0.5 (inclusion, pre-hair transplant)
assessed from standardised photographs, rated by several investigators (or trained people) on blinded groups, on the recipient area on 11-point scale
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)
Time frame: Months 0 and 0.5
Physical signs erythema and scalp oedema scoring (in vivo assessments of) on 11-point scale
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)
Time frame: Months 0, 0.5, 1 and 3
Physical signs crusts and healing scoring (in vivo assessments of) on 11-point scale
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
Time frame: Months 0 and 0.5
Visual evaluation by Trichoscopy of crusts and erythema
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)
Time frame: Months 0, 0.5, 1, 3, 6, 9 and 12 and monthly between each visit
assessed by the subject on the recipient area, according to a 5-point scale
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
Time frame: At each visit from Month 0 (hair transplant)
assessed by the subject on the recipient area, according to a 11-point scale
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
Time frame: Months 0, 1, 6 and 12
assessed by the subject with subject's questionnaire
Evaluate the tolerance of the products for 12 months of use by adverse events
Time frame: At each visit from Month 0 to Month 12
Adverse events
Evaluate the tolerance of the products for 12 months of use by physical and functional signs
Time frame: At each visit from Month 0 to Month 12
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
Evaluate the tolerance of the products for 12 months of use by global tolerance per subject
Time frame: at Month 0 (for period of pre-transplant) and at Month 12 (end of the study)
assessed by the investigator for both groups and per subject, considering all individual AE and their characteristics, based on a 5-point scale
Evaluate the subject's compliance regarding the test product
Time frame: At each visit from Month 0 to Month 12
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RV4986A lotion in people with Androgenic Alopecia, run by Pierre Fabre Dermo Cosmetique at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Months 0.5, 1, 3, 6, 9 and 12 compared to Month 0 (hair transplant)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.