Safety and Efficacy of Nitric Oxide Gel in Promoting Hair Growth in Male Human Subjects With Androgenetic Alopecia
|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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
|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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347957
|Contact: CHIH JUNG HSU||0953661694|
|Dermatological Department, CMUH||Recruiting|
|Principal Investigator:||Chih JUNG HSU||Dermatological department, CMUH|