Abstract
Background: Topical minoxidil solution 2% stimulates new hair growth and helps stop the loss of hair in individuals with androgenetic alopecia (AGA). Results can be variable, and historical experience suggests that higher concentrations of topical minoxidil may enhance efficacy.
Objective: The purpose of this 48-week, double-blind, placebo-controlled, randomized, trial was to compare 5% topical minoxidil with 2% topical minoxidil and placebo in the treatment of men with AGA.
Methods: A total of 393 men (18-49 years old) with AGA applied 5% topical minoxidil solution (n = 157), 2% topical minoxidil solution (n = 158), or placebo (vehicle for 5% solution; n = 78) twice daily. Efficacy was evaluated by scalp target area hair counts and patient and investigator assessments of change in scalp coverage and benefit of treatment.
Results: After 48 weeks of therapy, 5% topical minoxidil was significantly superior to 2% topical minoxidil and placebo in terms of change from baseline in hair count, patient rating of scalp coverage and treatment benefit, and investigator rating of scalp coverage. Hair count data indicate that response to treatment occurred with 5% compared with 2% topical minoxidil. Additionally, data from a patient questionnaire on quality of life, global benefit, hair growth, and hair demonstrated that 5% topical minoxidil helped improve patients' psychosocial perceptions of hair loss. An increased occurrence and local irritation was observed with 5% topical minoxidil compared with 2% topical minoxidil.
Conclusion: In men with AGA, 5% topical minoxidil was clearly superior to 2% topical minoxidil and placebo in increasing hair regrowth, and the magnitude of its effect was marked (45% more hair regrowth than 2% topical minoxidil at week 48). Men who used 5% topical minoxidil also had an earlier response to treatment than those who used 2% topical minoxidil. Psychosocial perceptions of hair loss in men with AGA were also improved. Topical minoxidil (5% and 2%) was well tolerated by the men in without evidence of systemic effects.
Results reported by the 150 physicians in the study did not differ substantially from results reported by the other men in the study.
Results of these two post-marketing studies generally confirm results of previous studies of the efficacy and safety. While many persons are benefited by 2% or 5% minoxidil in treatment of pattern hair loss, results vary from person to person for a variety including individual responses to the agent and relentlessness of hair loss progression. Results that are satisfactory to some patients are unsatisfactory to others, perhaps because results do not meet pre-treatment expectations.
Best treatment results are likely to be realized when the person with hair loss consults a physician hair restoration specialist. Rational expectations for treatment outcome are most reliably based on (1) diagnosis of the cause of hair loss, (2) assessment of the characteristics of hair loss in the individual patient, and (3) a treatment plan based upon diagnosis and assessment, and agreed upon by the patient and physician hair restoration specialist. A physician hair restoration specialist is able to monitor the effectiveness of medical therapy clinically and through use of comparison photos, as well as provide other medical and surgical options to augment the benefits of minoxidil. Minoxidil solution is even more effective when combined with the oral medication and is also compatible with hair restoration surgery. For example, a patient may have follicular unit transplantation to create a natural looking hairline near the front of the scalp, and use minoxidil and finasteride to preserve the hair on top of the scalp.
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