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

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.

Study Overview

• Status: Unknown
• Conditions: Alopecia Androgenica
• Intervention / Treatment: Other: Nitric Oxide (NO) Gel; Other: Placebo gel

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • Dermatological Department, CMUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male subjects >= 20 and <= 65 years of age.
2. Subjects with hair loss caused by androgenetic alopecia.
3. Subjects who are healthy without any serious diseases that require hospitalization during the study period.
4. 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.

Exclusion Criteria:

1. Subjects who received any treatment for hair loss within 6 months or finasteride within 12 months
2. Subjects with diagnosis of cancer and is still on active therapies.
3. Subjects with diagnosis of an active disease and is still under regular treatment for this disease
4. Subjects with hair loss caused by a known chronic disease.
5. 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.
6. Subjects with thyroid disease.
7. Subjects iron-deficiency anemia.
8. Subjects with skin diseases of the scalp, including severe seborrhoeic dermatitis, psoriasis, lichenoid eruption, tinea capitis, or other scalp infections or infestations
9. Subjects with any known allergic reaction to any ingredient in the 2 gel preparations.
10. Subjects who have been enrolled into any clinical study in the preceding 6 months prior to randomization.
11. Subjects who have taken medications that are known to induce hypotrichosis or hypertrichosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Gel	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.
EXPERIMENTAL: Nitric Oxide (NO) Gel	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Chih JUNG HSU, Dermatological Department, CMUH

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ANTICIPATED): August 1, 2013
• Study Completion (ANTICIPATED): August 1, 2013

Study Registration Dates

• First Submitted: May 3, 2011
• First Submitted That Met QC Criteria: May 4, 2011
• First Posted (ESTIMATE): May 5, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: DMR98-IRB-231