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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. (see Contacts and Locations)
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

May 3, 2011
February 12, 2013
August 2012
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01347957 on ClinicalTrials.gov Archive Site
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)

Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Nitric Oxide Gel in Promoting Hair Growth in Male Human Subjects With Androgenetic Alopecia
Not Provided

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alopecia Androgenica
  • 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.
  • 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
    Intervention: Other: Nitric Oxide (NO) Gel
  • Placebo Comparator: Placebo Gel
    Intervention: Other: Placebo gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Male
20 Years to 65 Years
Yes
Contact: CHIH JUNG HSU 0953661694
Taiwan
 
NCT01347957
DMR98-IRB-231
Yes
China Medical University Hospital
China Medical University Hospital
Not Provided
Principal Investigator: Chih JUNG HSU Dermatological department, CMUH
China Medical University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP