Androgenetic AlopeciaNCT06590779
Benefits of a Cosmetic Anti-hair Loss in Males With Hair Loss
A study testing Aminexil® active+ lotion and Finasteride 1mg in people with Androgenetic Alopecia, run by Cosmetique Active International.
Trial summary
Androgenetic alopecia (AGA), also known as androgenic alopecia or male pattern baldness, is the most common type of progressive hair loss. AGA is a polygenetic condition with varying severity, age of onset, and scalp location of hair loss. Read more about this study
- Who is it for?
- Ages 18 to 41 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Aminexil® active+ lotion and Finasteride 1mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2024to 2 May 2026
- 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 to 41 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subject aged 18-41 years old with skin type I to IV according to the Fitzpatrick scale;
- Affected by androgenetic alopecia with hair loss evaluated grade IIA to IV the modified Norwood-Hamilton scale;
- Subject with chestnut brown, dark or black hair;
- Subject with hair length ≥ 3 cm on the vertex and agreeing to keep this minimum length for the duration of the study;
- Subject agreeing to have a shaved zone of 1.5 cm² on scalp area;
- Subject accepting not to dye, bleach his hair or to do a permanent wave during the whole study duration;
- Subject accepting to use condoms if her partner is pregnant.
Who cannot join
- Female subject;
- Subject presenting a life-threatening endocrine disease, neoplasia or other serious diseases;
- Subjects suffering from chemo-induced alopecia (poisoning, medicines), or resulting from a chronic disease (genetic, endocrine, immunological, deficiencies), seasonal hair loss;
- Subject having any other concomitant dermatological affection of the scalp (psoriasis, seborrheic dermatitis, eczema, other alopecia than androgenetic);
- Subject suffering from a recurrent, acute, non-stabilized or evolving disease judged by the investigator able to interfere with the study needs and hair growth;
- Subject having had surgical intervention for capillary correction (e.g., hair transplant) or intending to have recourse to this surgery during the entire study period;
Show all 17Show fewer
- Subject presenting a hypersensitivity to any of the components of the finasteride medication or to any 5-alpha-reductase inhibitor;
- Subject that has applied or taken prior to the start of the study (screening) interfering drugs or products
- Subject taking any other medical treatment (topic or per os) likely to interfere on hair growth or hair loss within 6 months prior to the screening visit;
- Subject following a long period (>30 days) treatment of anti-inflammatory within 4 months prior to the start of the study (screening visit);
- Subject taking topic cosmetic treatment or per os nutritional supplement likely to interfere on hair growth or hair loss during the last 3 months prior to the screening visit;
- Subject having a topical or oral route treatment of the scalp (anti-seborrheic, anti-dandruff, daily friction) within 2 weeks prior to the screening visit;
- Subject who has been exposed within one month prior to the screening visit in an intense or excessive manner to sun (natural or artificial) or during the study;
- Subject having a wig or hair extension;
- Protected subject as defined in the Articles of the French Public Health Code. Article 1121-7: person deprived of liberty by a judicial or administrative decision, or subject to psychiatric care, or person admitted to a health or social institution for purposes other than the research. Article 1121-8: adult person subject to a legal protection measure or unable to express his/her consent;
- Subject unable to communicate or cooperate with the Investigator due to poor mental development, language problems or impaired cerebral function;
- Subject currently participating in another clinical study or being in an exclusion period of another clinical study;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Benefits of a Cosmetic Anti-hair Loss Lotion Applied in Combination With Finasteride in Male Subjects With Hair Loss: Investigator-blinded, Randomized, Multi-center Study Performed Under Dermatological Control
Androgenetic alopecia (AGA), also known as androgenic alopecia or male pattern baldness, is the most common type of progressive hair loss. AGA is a polygenetic condition with varying severity, age of onset, and scalp location of hair loss. In men, hair loss typically involves the temporal and vertex region while sparing the occipital region: the characteristic "horseshoe" pattern. Incidence and prevalence of AGA depend on age and race.
Vichy has developed a new cosmetic anti hair loss lotion with the aim of acting on androgenic alopecia. The aim is to improve the efficacy on hair loss of the association of the lotion with finasteride versus finasteride alone.
The primary objective of this investigator-blinded, randomized multi-center study is to quantitatively evaluate, using the phototrichogram method, the efficacy of a lotion associated with finasteride versus finasteride alone on hair growth parameters in male subjects with androgenetic alopecia.
- Conditions
- Androgenetic Alopecia
- Being tested
- Aminexil® active+ lotion, Finasteride 1mg
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminexil® active+ lotionOther
Aminexil® active+ lotion
Finasteride 1mgOther
Finasteride 1 mg
| Study group | Role | What they receive |
|---|---|---|
| Finasteride 1 mg & Aminexil® active+ lotion | Experimental | Administration of Finasteride 1 mg + Aminexil® active+ lotion Receives: Other: Aminexil® active+ lotion; Other: Finasteride 1mg |
| Finasteride 1 mg | Active comparator | Administration of Finasteride 1 mg Receives: Other: Finasteride 1mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Measured: baseline T0
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Measured: Day 3
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Measured: Day 84
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Measured: Day 86
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Measured: Day 168
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Measured: Day 170
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Measured: Day 336
Phototrichogram
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Measured: Day 338
Secondary outcomes (34)
Scalp coverage evaluation
on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible
Measured: baseline Day 1
Scalp coverage evaluation
on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible
Measured: Day 84
Scalp coverage evaluation
on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible
Measured: Day 168
Scalp coverage evaluation
on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible
Measured: Day 336
Subject Evaluation on Vertex and Frontal Area of hair quality
scale from -3: greatly decreased to 3: greatly increased
Measured: baseline Day 1
Subject Evaluation on Vertex and Frontal Area of hair quality
scale from -3: greatly decreased to 3: greatly increased
Measured: Day 84
Subject Evaluation on Vertex and Frontal Area of hair quality
scale from -3: greatly decreased to 3: greatly increased
Measured: Day 168
Subject Evaluation on Vertex and Frontal Area of hair quality
scale from -3: greatly decreased to 3: greatly increased
Measured: Day 252
Subject Evaluation on Vertex and Frontal Area of hair quality
scale from -3: greatly decreased to 3: greatly increased
Measured: Day 336
Quality of life assessment
Non-validated 13-point questionnaire; point 1-6: on a 5 point scale from never to always point 7-13 on a 5-point scale from totally agree to not agree at all
Measured: baseline Day 1
Quality of life assessment
Non-validated 13-point questionnaire; point 1-6: on a 5 point scale from never to always point 7-13 on a 5-point scale from totally agree to not agree at all
Measured: Day 84
Quality of life assessment
Non-validated 13-point questionnaire; point 1-6: on a 5 point scale from never to always point 7-13 on a 5-point scale from totally agree to not agree at all
Measured: Day 168
Quality of life assessment
Non-validated 13-point questionnaire; point 1-6: on a 5 point scale from never to always point 7-13 on a 5-point scale from totally agree to not agree at all
Measured: Day 336
Local discomfort
scale from 0: none to 9: hugely
Measured: baseline Day 1
Local discomfort
scale from 0: none to 9: hugely
Measured: Day 84
Local discomfort
scale from 0: none to 9: hugely
Measured: Day 168
Local discomfort
scale from 0: none to 9: hugely
Measured: Day 336
Local reactions
scale from 0: none to 4: very severe
Measured: baseline Day 1
Local reactions
scale from 0: none to 4: very severe
Measured: Day 84
Local reactions
scale from 0: none to 4: very severe
Measured: Day 168
Local reactions
scale from 0: none to 4: very severe
Measured: Day 336
Adverse events
Questioning
Measured: baseline Day 1
Adverse events
Questioning
Measured: baseline Day 3
Adverse events
Questioning
Measured: Day 42
Adverse events
Questioning
Measured: Day 84
Adverse events
Questioning
Measured: Day 86
Adverse events
Questioning
Measured: Day 126
Adverse events
Questioning
Measured: Day 168
Adverse events
Questioning
Measured: Day 170
Adverse events
Questioning
Measured: Day 210
Adverse events
Questioning
Measured: Day 252
Adverse events
Questioning
Measured: Day 294
Adverse events
Questioning
Measured: Day 336
Adverse events
Questioning
Measured: Day 338
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Nov 2024 (estimated)
- Primary completion2 Dec 2025 (estimated)
- Study completion2 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Finasteride 1mg Arm 2: Finasteride 1mg + Aminexil® active+ lotion
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire de Nice, Saint-Louis Hospital, Paris, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590779
- Sponsor's protocol ID
- VCY23-015
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefits of a Cosmetic Anti-hair Loss Lotion Applied in Combination With Finasteride in Male Subjects With Hair Loss: Investigator-blinded, Randomized, Multi-center Study Performed Under Dermatological Control
- ClinicalTrials.gov ID
- NCT06590779
- Acronym / sponsor ID
- VCY23-015
- Conditions
- Androgenetic Alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire de Nice, Saint-Louis Hospital, Paris, France
- Study start
- 2 Nov 2024 (estimated)
- Primary completion
- 2 Dec 2025 (estimated)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 19 Sep 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.
Androgenetic alopecia (AGA), also known as androgenic alopecia or male pattern baldness, is the most common type of progressive hair loss. AGA is a polygenetic condition with varying severity, age of onset, and scalp location of hair loss. In men, hair loss typically involves the temporal and vertex region while sparing the occipital region: the characteristic "horseshoe" pattern. Incidence and prevalence of AGA depend on age and race.
Vichy has developed a new cosmetic anti hair loss lotion with the aim of acting on androgenic alopecia. The aim is to improve the efficacy on hair loss of the association of the lotion with finasteride versus finasteride alone.
The primary objective of this investigator-blinded, randomized multi-center study is to quantitatively evaluate, using the phototrichogram method, the efficacy of a lotion associated with finasteride versus finasteride alone on hair growth parameters in male subjects with androgenetic alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Arm 1: Finasteride 1mg Arm 2: Finasteride 1mg + Aminexil® active+ lotion
| Arm | Type | Receives |
|---|---|---|
| Finasteride 1 mg & Aminexil® active+ lotion | Experimental | Other: Aminexil® active+ lotion, Other: Finasteride 1mgAdministration of Finasteride 1 mg + Aminexil® active+ lotion |
| Finasteride 1 mg | Active comparator | Other: Finasteride 1mgAdministration of Finasteride 1 mg |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male subject aged 18-41 years old with skin type I to IV according to the Fitzpatrick scale;
- Affected by androgenetic alopecia with hair loss evaluated grade IIA to IV the modified Norwood-Hamilton scale;
- Subject with chestnut brown, dark or black hair;
- Subject with hair length ≥ 3 cm on the vertex and agreeing to keep this minimum length for the duration of the study;
- Subject agreeing to have a shaved zone of 1.5 cm² on scalp area;
Key exclusion criteria (17 listed)
- Female subject;
- Subject presenting a life-threatening endocrine disease, neoplasia or other serious diseases;
- Subjects suffering from chemo-induced alopecia (poisoning, medicines), or resulting from a chronic disease (genetic, endocrine, immunological, deficiencies), seasonal hair loss;
- Subject having any other concomitant dermatological affection of the scalp (psoriasis, seborrheic dermatitis, eczema, other alopecia than androgenetic);
- Subject suffering from a recurrent, acute, non-stabilized or evolving disease judged by the investigator able to interfere with the study needs and hair growth;
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 |
|---|---|---|
| Aminexil® active+ lotionAminexil® active+ lotion | Other | Finasteride 1 mg & Aminexil® active+ lotion |
| Finasteride 1mgFinasteride 1 mg | Other | Finasteride 1 mg, Finasteride 1 mg & Aminexil® active+ lotion |
Primary outcome
Phototrichogram
Time frame: baseline T0
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Phototrichogram
Time frame: Day 3
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Phototrichogram
Time frame: Day 84
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Phototrichogram
Time frame: Day 86
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Phototrichogram
Time frame: Day 168
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Phototrichogram
Time frame: Day 170
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Phototrichogram
Time frame: Day 336
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
Phototrichogram
Time frame: Day 338
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles
34 secondary outcomes
Scalp coverage evaluation
Time frame: baseline Day 1
Scalp coverage evaluation
Time frame: Day 84
Scalp coverage evaluation
Time frame: Day 168
Scalp coverage evaluation
Time frame: Day 336
Subject Evaluation on Vertex and Frontal Area of hair quality
Time frame: baseline Day 1
Subject Evaluation on Vertex and Frontal Area of hair quality
Time frame: Day 84
Subject Evaluation on Vertex and Frontal Area of hair quality
Time frame: Day 168
Subject Evaluation on Vertex and Frontal Area of hair quality
Time frame: Day 252
Subject Evaluation on Vertex and Frontal Area of hair quality
Time frame: Day 336
Quality of life assessment
Time frame: baseline Day 1
Quality of life assessment
Time frame: Day 84
Quality of life assessment
Time frame: Day 168
Quality of life assessment
Time frame: Day 336
Local discomfort
Time frame: baseline Day 1
Local discomfort
Time frame: Day 84
Local discomfort
Time frame: Day 168
Local discomfort
Time frame: Day 336
Local reactions
Time frame: baseline Day 1
Local reactions
Time frame: Day 84
Local reactions
Time frame: Day 168
Local reactions
Time frame: Day 336
Adverse events
Time frame: baseline Day 1
Adverse events
Time frame: baseline Day 3
Adverse events
Time frame: Day 42
Adverse events
Time frame: Day 84
Adverse events
Time frame: Day 86
Adverse events
Time frame: Day 126
Adverse events
Time frame: Day 168
Adverse events
Time frame: Day 170
Adverse events
Time frame: Day 210
Adverse events
Time frame: Day 252
Adverse events
Time frame: Day 294
Adverse events
Time frame: Day 336
Adverse events
Time frame: Day 338
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
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.
Questions about this trial
What is this clinical trial studying?
A study testing Aminexil® active+ lotion and Finasteride 1mg in people with Androgenetic Alopecia, run by Cosmetique Active International.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Faure (33049643274, julie.faure@loreal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phototrichogram (time frame: baseline T0). The study lists 8 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 19 Sep 2024.