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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Nice | OTHER |
| Saint-Louis Hospital, Paris, France | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finasteride 1 mg & Aminexil® active+ lotion | Experimental | Administration of Finasteride 1 mg + Aminexil® active+ lotion |
|
| Finasteride 1 mg | Active Comparator | Administration of Finasteride 1 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminexil® active+ lotion | Other | Aminexil® active+ lotion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phototrichogram | photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles | baseline T0 |
| Phototrichogram | photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles | Day 3 |
| Phototrichogram | photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles | Day 84 |
| Phototrichogram | photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles | Day 86 |
| Phototrichogram | photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles | Day 168 |
| Phototrichogram | photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles | Day 170 |
| Phototrichogram | photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles | Day 336 |
| Phototrichogram |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline Day 1 |
| Scalp coverage evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Faure | Contact | 33049643274 | julie.faure@loreal.com |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Arm 1: Finasteride 1mg Arm 2: Finasteride 1mg + Aminexil® active+ lotion
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Investigator blinded, randomised study
| Finasteride 1mg |
| Other |
Finasteride 1 mg |
|
photo of the scalp to assess the rate of hair growth, size of hair fibers and frequency of telogen hair follicles |
| Day 338 |
on a scale 6-point clinical scale from 0: Scalp no visible/Hair completely recovering the scalp to 5:Scalp totally visible
| 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 | 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 | Day 336 |
| Subject Evaluation on Vertex and Frontal Area of hair quality | scale from -3: greatly decreased to 3: greatly increased | baseline Day 1 |
| Subject Evaluation on Vertex and Frontal Area of hair quality | scale from -3: greatly decreased to 3: greatly increased | Day 84 |
| Subject Evaluation on Vertex and Frontal Area of hair quality | scale from -3: greatly decreased to 3: greatly increased | Day 168 |
| Subject Evaluation on Vertex and Frontal Area of hair quality | scale from -3: greatly decreased to 3: greatly increased | Day 252 |
| Subject Evaluation on Vertex and Frontal Area of hair quality | scale from -3: greatly decreased to 3: greatly increased | 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 | 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 | 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 | 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 | Day 336 |
| Local discomfort | scale from 0: none to 9: hugely | baseline Day 1 |
| Local discomfort | scale from 0: none to 9: hugely | Day 84 |
| Local discomfort | scale from 0: none to 9: hugely | Day 168 |
| Local discomfort | scale from 0: none to 9: hugely | Day 336 |
| Local reactions | scale from 0: none to 4: very severe | baseline Day 1 |
| Local reactions | scale from 0: none to 4: very severe | Day 84 |
| Local reactions | scale from 0: none to 4: very severe | Day 168 |
| Local reactions | scale from 0: none to 4: very severe | Day 336 |
| Adverse events | Questioning | baseline Day 1 |
| Adverse events | Questioning | baseline Day 3 |
| Adverse events | Questioning | Day 42 |
| Adverse events | Questioning | Day 84 |
| Adverse events | Questioning | Day 86 |
| Adverse events | Questioning | Day 126 |
| Adverse events | Questioning | Day 168 |
| Adverse events | Questioning | Day 170 |
| Adverse events | Questioning | Day 210 |
| Adverse events | Questioning | Day 252 |
| Adverse events | Questioning | Day 294 |
| Adverse events | Questioning | Day 336 |
| Adverse events | Questioning | Day 338 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |