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

NCT01347957 | Unknown Phase 1 DMC

• 1 other identifier: DMR98-IRB-231
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the difference in TAHC between baseline and after 24-week treatment (NO vs. placebo groups).

  24 weeks

Secondary Outcomes (1)

• The secondary efficacy end point will be subjective assessment of improvement.

  24 weeks

Study Arms (2)

Nitric Oxide (NO) Gel

EXPERIMENTAL

Other: Nitric Oxide (NO) Gel

Placebo Gel

PLACEBO COMPARATOR

Other: Placebo gel

Interventions

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.

Nitric Oxide (NO) Gel

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.

Placebo Gel

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects \>= 20 and \<= 65 years of age.
• Subjects with hair loss caused by androgenetic alopecia.
• Subjects who are healthy without any serious diseases that require hospitalization during the study period.
• Subjects who are capable of understanding and having signed the Informed Consent Form after detailed description of the treatment procedures and potential risks and benefits.

You may not qualify if:

• Subjects who received any treatment for hair loss within 6 months or finasteride within 12 months
• Subjects with diagnosis of cancer and is still on active therapies.
• Subjects with diagnosis of an active disease and is still under regular treatment for this disease
• Subjects with hair loss caused by a known chronic disease.
• Subjects who are on vasodilators or other medication with pharmacological actions that may lead to excessive formation of nitric oxide or may accentuate drug effects due to excessive formation of nitric oxide.
• Subjects with thyroid disease.
• Subjects iron-deficiency anemia.
• Subjects with skin diseases of the scalp, including severe seborrhoeic dermatitis, psoriasis, lichenoid eruption, tinea capitis, or other scalp infections or infestations
• Subjects with any known allergic reaction to any ingredient in the 2 gel preparations.
• Subjects who have been enrolled into any clinical study in the preceding 6 months prior to randomization.
• Subjects who have taken medications that are known to induce hypotrichosis or hypertrichosis.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Dermatological Department, CMUH

Taichung, Taiwan

RECRUITING

MeSH Terms

Interventions

Nitric Oxide; Gels

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Chih JUNG HSU

  Dermatological department, CMUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHIH JUNG HSU

CONTACT

0953661694

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 5, 2011
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

TW (1)