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| Name | Class |
|---|---|
| Gleneagles CRC Pte Ltd. | UNKNOWN |
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The purpose of this study is to evaluate the safety and efficacy in relation to dosing in the administration of Hair Stimulating Complex (HSC) in healthy men. HSC will be injected intradermally in the scalps of men with male pattern baldness (i.e. androgenetic alopecia).
HSC consists of proteins secreted by human dermal cells under proprietary culture conditions that include reduced oxygen and bioreactors. Under these conditions, the cells secrete soluble proteins that include both growth factors and soluble precursors to the deposited extracellular matrix. Several of these proteins are known to be important in the control of the hair cycle and will stimulate resting hair follicles to resume hair formation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSC- Hair Stimulating Complex | Experimental | Hair Stimulating Complex will be injected intradermally into the scalp of the test subject at 2 timepoints (Baseline and 6 Weeks after Baseline) using sterile syringes with 30 gauge needles at a volume of 0.1 mL per injection. A total of 8 injections (about 3mm apart) will be administered into one of the the 2 randomized sites (left or right) of the subject's scalp. Six weeks after the Baseline injection, the same treatment site will receive a repeat dose (the same volume and number of injections as used in the baseline) with no crossover. |
|
| Dulbecco's Modified Eagle Medium, DMEM | Placebo Comparator | Dulbecco's Modified Eagle Medium (DMEM) will be administered the same way as described above into treatment zone of the test subject's scalp not treated with HSC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hair Stimulating Complex (HSC) | Biological | Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic safety measures will be assessed by measuring vital signs, adverse experiences, laboratory tests (hematology, clinical chemistry and urinalysis)and immunological response (anti-drug antibodies) | Clinically significant change from screening visit to Week 12 | |
| Non-vellus hair counts | Change from Baseline to week 12 in treatment areas |
| Measure | Description | Time Frame |
|---|---|---|
| Hair Thickness Density | Change from Baseline to week 48 in treatment areas | |
| Local safety measures will be assessed by clinical exam of treatment areas and monitoring adverse events | Clinically significant change from Screening visit to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Marie Reyes-Cacas, MD | The Medical City | Principal Investigator |
| Julieta P. Arambulo, MD | The Medical City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medical City | Pasig | Manila | Philippines |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 13, 2017 | |
| Reset | Jun 26, 2018 | |
| Release | Mar 7, 2019 | |
| Reset | Jun 12, 2019 | |
| Release | Aug 13, 2019 | |
| Reset | Sep 13, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 13, 2017 | Jun 26, 2018 | |||
| Mar 7, 2019 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Dulbecco's Modified Eagle Medium, DMEM | Device | Study preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6. |
|
| Jun 12, 2019 |
| Aug 13, 2019 | Sep 13, 2019 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |