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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified February 2013 by China Medical University Hospital.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

China Medical University Hospital

ClinicalTrials.gov Identifier:

NCT01347957

First received: May 3, 2011

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

Purpose

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	Intervention	Phase
Alopecia Androgenica	Other: Nitric Oxide (NO) Gel Other: Placebo gel	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:

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:

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)


Estimated Enrollment:	60
Study Start Date:	August 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility


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

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347957

Contacts


Contact: CHIH JUNG HSU	0953661694

Locations


Taiwan
Dermatological Department, CMUH	Recruiting
Taichung, Taiwan

Sponsors and Collaborators

China Medical University Hospital

Investigators


Principal Investigator:	Chih JUNG HSU	Dermatological department, CMUH

More Information


Responsible Party:	China Medical University Hospital
ClinicalTrials.gov Identifier:	NCT01347957 History of Changes
Other Study ID Numbers:	DMR98-IRB-231
Study First Received:	May 3, 2011
Last Updated:	February 12, 2013

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 21, 2017

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