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

This study is currently recruiting participants.
Verified February 2013 by China Medical University Hospital
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary efficacy end point will be subjective assessment of improvement. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

    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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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

No publications provided

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
Health Authority: Taiwan: Institutional Review Board

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
Pharmacologic Actions
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013