NCT01347957

Safety and Efficacy of Nitric Oxide Gel in Promoting Hair Growth in Male Human Subjects With Androgenetic Alopecia

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Preclinical studies showed the Nitric Oxide (NO) gel significantly promoted hair follicle formation and growth in both rat and mouse models. The NO gel induced major physiological, developmental, and structural changes in the skin of mammals to increase the number of hair follicles, follicle stem cell development and regeneration as well as hair shaft elongation, and accelerated hair growth rate. Based on our animal model findings, the investigators hypothesize that the nitric oxide releasing gel could be used as a medical treatment for hair growth in humans. The objective of this trial is to evaluate the safety and efficacy of this NO gel (XN-001), in comparison with a placebo gel in subjects in a 24-week treatment schedule.

Conditions

• Alopecia Androgenica

Interventions

Type	Name	Description
OTHER	Nitric Oxide (NO) Gel	Nitric Oxide (NO) Gel is created by premixing of contents from 2 separate gel bottles. The first bottle, NO gel, is a solution of sodium nitrite (14.6mM) in distilled water with hydroxyethylcellulose (molecular weight 50,000-1,250,000) added for gel formation. The second bottle, Releasing-stimulator gel, is a solution of maleic acid (14.6mM) and ascorbic acid (14.6mM) in distilled water with hydroxyethylcellulose added for gel formation.
OTHER	Placebo gel	The placebo gel is created by premixing of contents from 2 separate gel bottles. The first bottle is phosphate-buffered saline. The second bottle is the second gel bottle (Releasing-stimulator gel) as described in experimental arm.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-05-05
• Last updated: 2013-02-15

Locations

1 site across 1 country: Taiwan