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

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. |
- The primary efficacy endpoint is the difference in TAHC between baseline and after 24-week treatment (NO vs. placebo groups). [ Time Frame: 24 weeks ]
- 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, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01347957
Contact: CHIH JUNG HSU | 0953661694 |
Taiwan | |
Dermatological Department, CMUH | Recruiting |
Taichung, Taiwan |
Principal Investigator: | Chih JUNG HSU | Dermatological department, CMUH |
Responsible Party: | China Medical University Hospital |
ClinicalTrials.gov Identifier: | NCT01347957 |
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 |
Alopecia Alopecia Areata Hypotrichosis 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 Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Gasotransmitters Protective Agents |