List of Minoxidil Studies, Clinical Trials, Research

Cosmetically acceptable hair growth was achieved in 18 patients (32%). The most notable indicators for regrowth of hair were the number of indeterminate hairs initially present, the duration of baldness, and the size of the balding area. No serious systemic or cutaneous side effects were noted.

1987: De Villez RL. Androgenetic alopecia treated with topical minoxidil. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):669-72.

Subjects using the 2% and 3% solutions of minoxidil showed a significant change in terminal and indeterminate hair counts (p less than 0.05) from the placebo group at 4 months. A progressive decrease in vellus hair counts with a concomitant increase in both indeterminate and terminal hair counts was noted during the 12-month period, suggesting that minoxidil applied topically partially reverses the balding phenomenon. (Article continues below ad)

1987: Kreindler TG. Topical minoxidil in early androgenetic alopecia. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):718-24.

Patients applying active medication had significantly greater growth of nonvellus hairs at 4 months than did their placebo counterparts (p = 0.0018 for 2% minoxidil vs placebo; p = 0.0167 for 3% minoxidil vs placebo). In patients crossed over from placebo to 3% minoxidil, the rate of growth of nonvellus hairs increased to fifteen hairs a month during the next 4 months and slowed to ten hairs a month during the last 4 months. Within-group analyses for month 12 evaluable patients demonstrated significant increases in total hair counts for all three groups (p less than or equal to 0.0001). According to investigator evaluations at month 12, 82% of the 2% minoxidil group, 78% of the 3% minoxidil group, and 83% of the placebo to 3% minoxidil group had new hair growth. Clinically insignificant minoxidil blood levels resulted from scalp absorption. Thirty-six medical events in twenty-six patients were deemed related to the study drug; twenty-seven of these events were dermatologic in nature, and all were mild and self-limiting.

1987: Savin RC. Use of topical minoxidil in the treatment of male pattern baldness. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):696-704.

The mean nonvellus hair count at month 4 was 162.8 in the 2% minoxidil group, 155.4 in the 3% minoxidil group, and 107.1 in the placebo group. The mean increase in the 2% and 3% treatment groups was 58.2 and 48.8, respectively, whereas the mean increase in the placebo group was 4.0. Total hair counts at month 4 demonstrated significantly more growth of hair in the 2% minoxidil group than in the placebo group (p = 0.013), with no significant difference between the 3% minoxidil group and the other two treatment groups.

1987: Koperski JA, Orenberg EK, Wilkinson DI. Topical minoxidil therapy for androgenetic alopecia. A 30-month study. Arch Dermatol. 1987 Nov;123(11):1483-7. Department of Dermatology, Stanford University School of Medicine, Calif.

At 30 months, mean hair counts had decreased from the 12-months level, but remained elevated over baseline counts, while mean bald-area diameters returned to baseline. However, 70% of the patients who did continue to use the drug for 30 months had 50% or more hairs than when they originally started the drug therapy. A subset of patients appeared to sustain a continued increase in hair counts after 12 months. No systemic side effects were noted.

1987: Olsen EA, Weiner MS. Topical minoxidil in male pattern baldness: effects of discontinuation of treatment. J Am Acad Dermatol. 1987 Jul;17(1):97-101.

Ten men with male pattern baldness who had been treated with 2% or 3% minoxidil for at least 4 months were evaluated for any changes in scalp hair growth on and off drug. Objective assessments by hair counts showed a mean doubling of nonvellus target scalp hairs on topical minoxidil and loss of most of these recruited hairs when the drug was discontinued. Four of ten men had nonvellus hair counts off topical minoxidil that fell below baseline levels. Thus, hair growth on topical minoxidil is not sustained when the drug is discontinued.

1987: Olsen EA, DeLong ER, Weiner MS. Long-term follow-up of men with male pattern baldness treated with topical minoxidil. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):688-95

Those subjects who continued with twice-daily application of topical minoxidil throughout the study had a mean change from baseline nonvellus hair count at 1 year of 323 (15 to 589 hairs) and 335 (13 to 808 hairs) at 2 years 9 months with maintenance topical minoxidil. There were subjects on both maintenance schedules of topical minoxidil who lost some of the nonvellus hair they had initially gained with topical minoxidil; however, there was a greater mean loss in those patients following the once-daily versus twice-daily topical minoxidil regimen (p = 0.05). No subject lost nonvellus target hair as compared with baseline.

1988: Spindler JR. The safety of topical minoxidil solution in the treatment of pattern baldness: the results of a 27-center trial. Clin Dermatol. 1988 Oct-Dec;6(4):200-12. No link available.

1989: Bouhanna P. Topical minoxidil used before and after hair transplantation. J Dermatol Surg Oncol. 1989 Jan;15(1):50-3. Hair Department, Hôpital Saint-Louis, Paris, France.

A 2% solution of topical minoxidil was applied on the recipient bald scalp of 16 patients aged 25 to 52 years with Hamilton classifications of androgenetic alopecia from III to VI. Therapy was begun 4 weeks before surgery, was interrupted for 3 weeks, and was started again and continued for 3 months. Four-millimeter donor grafts were inserted into 3.5-mm recipient sites. Follow-up utilizing macrophotography was done for 3 months on 4 grafts near a tattooed area. In 71% of the 64 grafts, partial or total hair is still growing without the shedding that usually occurs 2-4 weeks after transplantation. Topical minoxidil seems to be an adjunct for a better evolution of grafts after hair transplantation surgery.

1990: Olsen EA, Weiner MS, Amara IA, DeLong ER. Five-year follow-up of men with androgenetic alopecia treated with topical minoxidil. J Am Acad Dermatol. 1990 Apr;22(4):643-6. : Department of Medicine, Duke University Medical Center

Thirty-one men with androgenetic alopecia completed 4 1/2 to 5 years of therapy with 2% and 3% topical minoxidil. Hair regrowth with topical minoxidil tended to peak at 1 year with a slow decline in regrowth over subsequent years. However, at 4 1/2 to 5 years, maintenance of nonvellus hairs beyond that seen at baseline was still evident. Topical minoxidil appears to be effective in helping to maintain nonvellus hair growth in men with androgenetic alopecia.

1990: Connors TJ, Cooke DE, De Launey WE, Downie M, Knudsen RG, Shumack S, Eggleston AS. Australian trial of topical minoxidil and placebo in early male pattern baldness. Australas J Dermatol. 1990;31(1):17-25. Monash Medical Centre Clayton, Vic.

Nine (12.5%) evaluable minoxidil treated patients compared with 2 (2.7%) evaluable placebo treated patients reported moderate or dense hair regrowth at week 24. Minimal regrowth was reported by 18 (25%) active group and 15 (20%) placebo group patients. The investigators considered that 3 (2%) of the minoxidil group and none of the placebo group had moderate hair regrowth and that none had dense regrowth. After 48 weeks treatment 28 (23%) patients considered that they had moderate hair regrowth and the investigators considered that 14 (12%) patients had moderate regrowth.

1992: Whiting DA, Jacobson C. Treatment of female androgenetic alopecia with minoxidil 2%. Int J Dermatol. 1992 Nov;31(11):800-4. : Department of Dermatology, University of Texas Southwestern Medical Center, Dallas.

RESULTS: 60% (9) of the patients in the minoxidil group showed minimal to moderate hair growth compared with 46% (6) of the patients in the placebo group. No serious side effects were encountered during this study, nor any significant changes in safety parameters. There were no dropouts due to medical events related to minoxidil 2%.

1993: Jacobs JP, Szpunar CA, Warner ML, Use of topical minoxidil therapy for androgenetic alopecia in women., Int J Dermatol. 1993 Oct;32(10):758-62. : Dermatology Division, Upjohn Laboratories, Kalamazoo, Michigan.

RESULTS: In the 2% minoxidil group, the mean increase in nonvellus hair count was 33 hairs, which was significantly greater than that of 19 hairs in the placebo group (P = 0.0001). The investigators observed that 44% of the patients in the 2% minoxidil group achieved new hair growth compared with 29% in the placebo group. When asked to evaluate their own hair growth, 55% of the women in the 2% minoxidil group compared to 41% of the women in the placebo group believed that they had achieved new hair growth. No clinically significant changes in vital signs were observed during the study and no serious or unexpected medical events were reported.

CONCLUSION: Topical minoxidil solution was significantly more effective than placebo in the treatment of androgenetic alopecia in women.

1993: Karam P. Topical minoxidil therapy for androgenic alopecia in the Middle East. The Middle-Eastern Topical Minoxidil Study Group. Int J Dermatol. 1993 Oct;32(10):763-6. American University Hospital of Beirut, New York, NY 10022.

Of the 161 patients considered evaluable at 48 weeks, 80% showed moderate to dense growth. The mean increase in nonvellus hair at 12 months was 234. CONCLUSIONS: The age of the patient and the type of baldness rather than its duration affected the final outcome.

1994: DeVillez RL, Jacobs JP, Szpunar CA, Warner ML. Androgenetic alopecia in the female. Treatment with 2% topical minoxidil solution. Arch Dermatol. 1994 Mar;130(3):303-7. : Division of Dermatology, University of Texas, San Antonio

RESULTS: After 32 weeks of treatment, the number of nonvellus hairs in a 1-cm2 evaluation site was increased by an average of 23 hairs in the 2% minoxidil group and by an average of 11 hairs in the placebo group. The 95% confidence interval for the difference in mean hair count change between the treatment groups was 5.9 to 17.5 hairs. The investigators determined that 13% in the minoxidil-treated group had moderate growth and 50% had minimal growth. This compared with 6% and 33%, respectively, in the placebo-treated group. Similarly, 60% of the patients in the 2% minoxidil group reported that they had new hair growth (20% moderate, 40% minimal) compared with 40% (7% moderate, 33% minimal) of the patients in the placebo group. No evaluations of dense hair growth were reported for either treatment group. No clinically significant changes in vital signs were observed and no serious or unexpected medical events were reported.

CONCLUSIONS: Topical minoxidil was significantly more effective than placebo in the treatment of female androgenetic alopecia.

2002: Olsen EA, Dunlap FE, Funicella T, Koperski JA, Swinehart JM, Tschen EH, Trancik RJ., A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men., J Am Acad Dermatol. 2002 Sep;47(3):377-85. : Duke Dermatopharmacology Study Center, Durham, North Carolina, USA.

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 nonvellus 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 earlier with 5% compared with 2% topical minoxidil. Additionally, data from a patient questionnaire on quality of life, global benefit, hair growth, and hair styling demonstrated that 5% topical minoxidil helped improve patients' psychosocial perceptions of hair loss. An increased occurrence of pruritus 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 this trial without evidence of systemic effects.

2002: Khandpur S, Suman M, Reddy BS. Comparative efficacy of various treatment regimens for androgenetic alopecia in men. J Dermatol. 2002 Aug;29(8):489-98. Department of Dermatology and S.T.D., Maulana Azad Meical College and Associated Lok Nayak Hospital, New Delhi, India.

Subjects receiving finasteride alone or in combination with minoxidil or ketoconazole showed statistically significant improvement (p<0.05) over minoxidil only recipients.

2003: Reiman, Patty, Beyond the vertex: objective evidence shows minoxidil's frontal-scalp performance. (Cosmetic Dermatology). Dermatology Times, Date: 3/1/2003

2003-2004: Johnson & Johnson Consumer & Personal Products Worldwide, A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss

Male subjects with androgenetic alopecia were enrolled in this fourteen-center trial. Subjects were randomized to use either 5% minoxidil or placebo foam twice daily for 16 weeks. A total of 143 subjects continued use of the 5% minoxidil foam for 8 to 12 months in an open-label phase to obtain safety data on 5% minoxidil topical foam when used twice daily for up to one year. The 5% minoxidil foam was shown to be effective in the treatment of male androgenetic alopecia in a 16 week trial. It was statistically significantly superior to placebo foam in the primary efficacy measure of mean change in the non-vellus hair count in the target region between Baseline and Week 16, and the subject rating assessed an overall improvement from Baseline. The efficacy of 5% minoxidil compared to placebo was confirmed by the secondary efficacy endpoints of scores from the expert panel review of hair regrowth when comparing photographs obtained at Baseline with photographs obtained at Week 16, as well as the percent change from Baseline in non-vellus hair counts within a pre-specified area of clipped hair. The 5% minoxidil foam formulation was well tolerated, the incidence of adverse events was similar between groups, and no safety concerns were raised based on clinical laboratory test results, vital signs or scalp irritation scores.

2004: Lucky AW, Piacquadio DJ, Ditre CM, Dunlap F, Kantor I, Pandya AG, Savin RC, Tharp MD. A randomized, placebo-controlled trial of 5% and 2% topical minoxidil solutions in the treatment of female pattern hair loss. J Am Acad Dermatol. 2004 Apr;50(4):541-53. Dermatology Research Associates Inc., Cincinnati, OH 45230

RESULTS: After 48 weeks of therapy, 5% topical minoxidil was superior to placebo for each of the 3 primary efficacy measures. The 2% topical minoxidil group demonstrated superiority over placebo for hair count and investigator assessment of hair growth/scalp coverage at week 48; differences in patient assessment of hair growth at week 48 were not significantly different from placebo. The 5% topical minoxidil group demonstrated statistical superiority over the 2% topical minoxidil group in the patient assessment of treatment benefit at week 48. Both 5% and 2% topical minoxidil helped improve psychosocial perceptions of hair loss in women with female pattern hair loss. An increased occurrence of pruritus, local irritation, and hypertrichosis was observed with 5% topical minoxidil versus 2% topical minoxidil and placebo.

CONCLUSION: In this 48-week study of 381 women with female pattern hair loss, 5% topical minoxidil was superior to placebo on each of the 3 primary efficacy end points: promoting hair growth as measured by change in nonvellus hair count and patient/investigator assessments of hair growth and scalp coverage. Application of 2% topical minoxidil was superior to placebo for assessments of nonvellus hair counts and investigator assessment of hair growth/scalp coverage at week 48; differences in patient assessment of hair growth at week 48 were not significantly different from placebo. At week 48, the 5% topical minoxidil group demonstrated statistical superiority over the 2% topical minoxidil group in the patient assessment of treatment benefit. Both concentrations of topical minoxidil were well tolerated by the women in this trial without evidence of systemic adverse effects. With the introduction of numerous herbal remedies for hair loss, of which most have not been tested in randomized, double-blind, placebo-controlled trials, it is important to describe well-controlled trials that demonstrate the efficacy and safety of topical drugs.

2004: Arca E, Açikgöz G, Taºtan HB, Köse O, Kurumlu Z. An open, randomized, comparative study of oral finasteride and 5% topical minoxidil in male androgenetic alopecia. Dermatology. 2004;209(2):117-25. Department of Dermatology, Gülhane Military Medical Academy, School of Medicine, Etlik-Ankara, Turkey.

2007: Tsuboi R, Tanaka T, Nishikawa T, Ueki R, Yamada H, Katsuoka K, Ogawa H, Takeda K. A randomized, placebo-controlled trial of 1% topical minoxidil solution in the treatment of androgenetic alopecia in Japanese women. Eur J Dermatol. 2007 Jan-Feb;17(1):37-44. Epub 2007 Feb 27. Tokyo Medical University, Department of Dermatology, Tokyo, Japan.

As assessed by investigators, 29.2% (40/137) of the patients had moderate or better improvement in the 1% topical minoxidil group compared to 11.8% (16/136) in the placebo group (p < 0.001 versus placebo). The effect on hair growth was assessed as improved or better by 36.5% (50/137) of the patients themselves in the 1% topical minoxidil group compared to 23.5% (32/136) in the placebo group (p = 0.019 versus placebo). The patients tolerated treatment with 1% topical minoxidil well without significant adverse effects.

2007: Mapar MA, Omidian M. Is topical minoxidil solution effective on androgenetic alopecia in routine daily practice? J Dermatolog Treat. 2007;18(5):268-70. Department of Dermatology, Imam Khomeini Hospital, Jundishapour Medical University, Ahvaz, Iran.

A total of 1495 men aged 20-40 years who suffered from androgenetic hair loss were selected among patients who were referred to two private dermatologists. They were subjected to treatment with 5% topical minoxidil solution. Almost all the patients gradually avoided continuing the treatment. Only in a few patients was the cessation of medication due to adverse effects. The causes of discontinuation in the majority of patients were the low effect of medication and an aversion to this topical treatment method. CONCLUSIONS: The insignificant cosmetic effect of minoxidil solution caused discontinuity of treatment among almost all patients.

2007: Hoedemaker C, van Egmond S, Sinclair R. Treatment of female pattern hair loss with a combination of spironolactone and minoxidil. Australas J Dermatol. 2007 Feb;48(1):43-5. Department of Dermatology, St Vincent's Hospital, University of Melbourne, Melbourne, Victoria, Australia.

A 53-year-old woman with clinical evidence of female pattern hair loss and histological evidence of androgenetic alopecia was initially treated with the oral antiandrogen spironolactone 200 mg daily. Serial scalp photography documented hair regrowth at 12 months; however, the hair regrowth plateaued, and at 24 months there had been no further improvement in hair density. Twice daily therapy with topical minoxidil 5% solution was then introduced and further regrowth documented, confirming the additive effect of combination therapy.

2009: Tsuboi R, Arano O, Nishikawa T, Yamada H, Katsuoka K. Randomized clinical trial comparing 5% and 1% topical minoxidil for the treatment of androgenetic alopecia in Japanese men. J Dermatol. 2009 Aug;36(8): 437-46. Department of Dermatology, Tokyo Medical University, Tokyo, Japan.

Page Last Modified: 02/25/2012