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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitric Oxide (NO) Gel | Experimental |
| |
| Placebo Gel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide (NO) Gel | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the difference in TAHC between baseline and after 24-week treatment (NO vs. placebo groups). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary efficacy end point will be subjective assessment of improvement. | Subjects will be instructed to fill out a questionnaire at week 24 to evaluate the overall condition of hair loss in comparison with baseline. Subjects will be evaluated for any possible adverse effects of study drug and any symptoms and signs of scalp irritation (stinging, burning, itching) | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CHIH JUNG HSU | Contact | 0953661694 |
| Name | Affiliation | Role |
|---|---|---|
| Chih JUNG HSU | Dermatological department, CMUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatological Department, CMUH | Recruiting | Taichung | Taiwan |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| D005782 | Gels |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
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|
| Placebo gel | Other | 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. |
|
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |