NCT01501617

Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia

The Clinical Effects of HSC (Hair Stimulating Complex) on Hair Growth in Androgenetic Alopecia: A Phase I/II Clinical Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Histogen · Industry
• Sex: Male
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
BIOLOGICAL	Hair Stimulating Complex (HSC)	Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6.
DEVICE	Dulbecco's Modified Eagle Medium, DMEM	Study preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2011-12-29
• Last updated: 2012-01-18

Locations

1 site across 1 country: Philippines