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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01347957
Recruitment Status : Unknown
Verified February 2013 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : May 5, 2011
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):
China Medical University Hospital

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.

Condition or disease Intervention/treatment Phase
Alopecia Androgenica Other: Nitric Oxide (NO) Gel Other: Placebo gel Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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.

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

Secondary Outcome Measures :
  1. The secondary efficacy end point will be subjective assessment of improvement. [ Time Frame: 24 weeks ]

    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)

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01347957

Contact: CHIH JUNG HSU 0953661694

Dermatological Department, CMUH Recruiting
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Principal Investigator: Chih JUNG HSU Dermatological department, CMUH

Responsible Party: China Medical University Hospital Identifier: NCT01347957     History of Changes
Other Study ID Numbers: DMR98-IRB-231
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents