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The purpose of this study is to assess whether cosmetic investigational product containing NGF-574H is safe and effective in the treatment of androgenic alopecia in asian adults.
NGF-574H is a obtained by collection of paracrine factors secreted by human umbilical cord blood-derived mesenchymal stem cell that was exposed in vitro to an artificially designed environment mimicking alopecia state in hair follicles to prime the composition of the paracrine factors optimized for hair growth. This study is to assess and confirm whether NGF-574H is safe and effective in the treatment of androgenic alopecia in asian adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGF-574H | Experimental | NGF-574H is hair serum with 5% conditioned media of umbilical cord blood-derived stem cells containing various trophic factors that help alleviate hair loss. NGF-574H will be directed to use on hair and scalp by subject her/himself at home twice a day (in the morning and evening) for 24 weeks. |
|
| placebo | Placebo Comparator | Hair serum without conditioned media of umbilical cord blood-derived stem cells will be directed to use on hair and scalp by subject her/himself at home twice a day (in the morning and evening) for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conditioned media of umbilical cord blood-derived stem cells | Other | Hair serum with 5% conditioned media of human umbilical cord blood-derived mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean total hair density (hair/cm2) |
| 0, 6, 12 and 24 weeks |
| Compare visual assessment before and after cosmetic treatment | Visual Assessment using the clinical picture by an investigator: 7 point score (-3 to 3) Visual assessment by a subject (Self-Assessment): 7 point score (-3 to 3) | 0, 6, 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean Telogen hair density | Measurement of telogen hair density, in comparison to initial value (baseline) and/or placebo product. | 0, 6, 12 and 24 weeks |
| Change in mean Anagen hair density |
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Inclusion Criteria:
Origin: Asian (Korean)
Age: adult from 18 to 60 years old
Sex: female (minimum 70) and male
Understanding of the language spoken in the research center: subjects able to read the documents they are presented with and to hold to what they are explained.
Social cover: subjects having medical coverage
Subjects whose state of health, at the moment of inclusion, (auto-questionnaires and medical examinations for the recruitment, selection and inclusion), are compatible with this type of study.
Subjects can be pursuit and observation during the study period.
Subjects have a "hair loss grade" as below criteria:
Subject with hair length ≥3cm in the vertex region and intending to keep this minimum length during the whole study period.
Subject accepting the constraints of the phototrichogram technique, i.e. agreeing to have 1 shaved zone of 1.5cm2 on the scalp.
Subject agreeing not to apply any topical treatment (other than the investigational product) or take any oral product or nutritional supplementation, or have any diet known to improve scalp and/or hair qualities or reduce hair loss during the whole study period.
Subject agreeing to use a neutral shampoo (subject's own shampoo)
Subject agrees to have a tattoo on the scalp on phototrichogram evaluation area.
Subject presenting preferably with chestnut brown, dark or black hair (in order to avoid problems of contrast)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byungcheol PARK, MD | Dankook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dankook University Hospital | Cheonan | Chung Nam | 31116 | South Korea |
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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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Product group / Control(placebo) group
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|
| Placebo | Other | Hair serum without conditioned media of human umbilical cord blood-derived mesenchymal stem cells |
|
Measurement of anagen hair density, in comparison to initial value (baseline) and/or placebo product.
| 0, 6, 12 and 24 weeks |
| Change in hair growth speed | Measurement of hair growth speed, in comparison to initial value (baseline) and/or placebo product. | 0, 6, 12 and 24 weeks |
| Change in hair diameter | Measurement of hair diameter, in comparison to initial value (baseline) and/or placebo product. Measure hair diameter using electronic outside micrometer. | 0, 6, 12 and 24 weeks |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |