A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men

doi:10.1067/mjd.2002.124088

Journal of the American Academy of Dermatology

Volume 47, Issue 3, September 2002, Pages 377-385

https://doi.org/10.1067/mjd.2002.124088 Get rights and content

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, multicenter 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 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. (J Am Acad Dermatol 2002;47:377-85.)

Section snippets

Patient population

Men eligible for inclusion in the trial were 18 to 49 years old with naturally dark hair and AGA characterized as vertex pattern 3, 4, 5, or 6 with a density rating of 4 to 7 according to the Savin Male Pattern and Density Scale.⁵ Patients were in good general health with no evidence of systemic illnesses (eg, cardiac, psychiatric, or scalp disease). Patients known to be hypersensitive to minoxidil were excluded, as were patients who concomitantly used hair restorers or systemic drugs

Baseline characteristics

Three hundred ninety-three men with AGA were enrolled in the trial. Patient demographic and hair loss features at baseline were similar among the treatment groups (Table I).

. Demographic and hair loss features at baseline

Variable	5% Minoxidil (n = 157)	2% Minoxidil (n = 158)	Placebo (n = 78)	Treatment P value
Age (y)
Mean (SD)	36.2 (6.4)	36.5 (6.5)	36.8 (6.4)	.797
Range	21-49	20-49	23-49
Race/ethnic group [No. (%) of patients]				.139^*
White	118 (75.2)	133 (84.2)	62 (79.5)
Black	1 (0.6)	4 (2.5)	0
Oriental/Asian	2 (1.3)	0	1

Discussion

This 48-week trial clearly showed that 5% topical minoxidil was significantly superior to 2% topical minoxidil (4/6 efficacy measures) and placebo (6/6 efficacy measures) in increasing hair growth in men with AGA. Five percent topical minoxidil produced 45% more hair regrowth compared with 2% topical minoxidil as determined by target area hair counts at 48 weeks (18.6 and 12.7 nonvellus hairs, respectively, Table III). A more rapid hair growth response was also apparent, with an equivalent

Acknowledgements

Pharmacia Corporation provided the topical minoxidil solutions and placebo used in the trial.

References (10)

D. Canfield
Photographic documentation of hair growth in androgenetic alopecia
Dermatol Clin
(1999)
VH Price et al.
Changes in hair weight and hair count in men with androgenetic alopecia, after application of 5% and 2% topical minoxidil, placebo, or no treatment
J Am Acad Dermatol
(1999)
E. Abell
Histologic response to topically applied minoxidil in male-pattern alopecia
Clin Dermatol
(1988)
EA. Olsen
Androgenetic alopecia
VH. Price
Treatment of hair loss
N Engl J Med
(1999)

There are more references available in the full text version of this article.

Cited by (292)

Biomedical applications of electrospun nanofibers in the management of androgenic alopecia
2023, Journal of Drug Delivery Science and Technology
Androgenic alopecia is a complex condition that affects the scalp, leading to hair thinning and hair loss. Approximately 50% of the total population worldwide suffers from hair loss. It is also estimated that the incidence of androgenetic alopecia in individuals will increase by 60% by 2035. Androgenetic alopecia has a significant impact on people's emotional health, mental health, and self-esteem. Early detection, continued drug treatment, and appropriate scalp care are the only solutions for timely treatment. Many treatments are available, but it is important to understand the underlying conditions, mechanisms, and types of alopecia. Conventional drugs are inexpensive, but not effective enough to accelerate the entire hair loss process. One of the promising current trends in innovative scalp repair are scaffolds, films, and nanofibers. These newer research areas are observed in tissue engineering in combination of traditional therapeutics with modern products and practices. There is growing interest in electrospun nanofibers with enormous porosity, excellent hygroscopicity, excellent oxygen exchange rate and antibacterial activity. The applications of nanofibers can be extended by using different polymer combinations and incorporating active pharmaceuticals (APIs) such as stem cells within the nanofiber network to treat the condition. This review describes the potential application of electrospun nanofibers in hair growth.
Nanotechnology-based techniques for hair follicle regeneration
2023, Biomaterials
The hair follicle (HF) is a multicellular complex structure of the skin that contains a reservoir of multipotent stem cells. Traditional hair repair methods such as drug therapies, hair transplantation, and stem cell therapy have limitations. Advances in nanotechnology offer new approaches for HF regeneration, including controlled drug release and HF-specific targeting. Until recently, embryogenesis was thought to be the only mechanism for forming hair follicles. However, in recent years, the phenomenon of wound-induced hair neogenesis (WIHN) or de novo HF regeneration has gained attention as it can occur under certain conditions in wound beds. This review covers HF-specific targeting strategies, with particular emphasis on currently used nanotechnology-based strategies for both hair loss-related diseases and HF regeneration. HF regeneration is discussed in several modalities: modulation of the hair cycle, stimulation of progenitor cells and signaling pathways, tissue engineering, WIHN, and gene therapy. The HF has been identified as an ideal target for nanotechnology-based strategies for hair regeneration. However, some regulatory challenges may delay the development of HF regeneration nanotechnology based-strategies, which will be lastly discussed.
Noninvasive Hair Rejuvenation
2023, Clinics in Plastic Surgery
The preparation of high minoxidil loaded transfersomes and its gel for effective topical treatment of alopecia
2023, Journal of Drug Delivery Science and Technology
Transfersomes is one of the most effective nanotechnology-based formulation for transdermal delivery of minoxidil (MXD), however the potential use was limited by its low drug content (DC) and entrapment efficiency (EE). In this study, efforts have been made to improve DC and EE of MXD in transfersomes for effective topical treatment of alopecia. By dissolving both MXD and edge activator (Tween 80) in aqueous phase than either or both of them co-dissolving in organic solvent with lipids (phospholipid and cholesterol with mass ratio of 5:1), the DC and EE of MXD transfersomes prepared by thin film hydration method were significantly increased. The optimized transfersomes (MT) and its gel (MT_gel) with mass ratio of drug, Tween 80 and lipids 3:1:18 have a spherical morphology without aggregation, and a particle size of not more than 100 nm. The differential scanning calorimetry measurements revealed that the drug in MT was in the non-crystalline state. MT and MT_gel exhibited better in vitro transdermal penetration ability and hair of C57BL/6 mice growth-promoting capacity than commercial formulations. MT_gel has non-irritation and is better than MT in skin adhesion, stability, potential for skin storage and hair growth promotion ability, which could endow it to be a promising strategy for topical treatment of alopecia.
The Effectiveness of Low-Level Light/Laser Therapy on Hair Loss
2024, Facial Plastic Surgery and Aesthetic Medicine
The Biology and Genomics of Human Hair Follicles: A Focus on Androgenetic Alopecia
2024, International Journal of Molecular Sciences

View all citing articles on Scopus

^☆: Funding sources: Pharmacia Corporation (formerly The Upjohn Company).

^☆☆: Disclosure: At the time the trial was conducted, Dr Koperski was affiliated with Scripps Clinic & Research Foundation, La Jolla, California, and Dr Swinehart was affiliated with Dermatology & Dermatology Surgery, Denver, Colorado. All authors except Ronald J. Trancik, PhD, were the clinical investigators involved in the conduct of the trial, which was funded by Pharmacia Corporation (formerly The Upjohn Company). In addition, Elise A. Olsen, MD, is a consultant for Pharmacia.

^★: The results of this trial were published as an abstract: Trancik R, Rundegren J. Topical minoxidil 5% in the treatment of male androgenetic alopecia. J Invest Dermatol (symposium proceedings) 1999;4:348.

^★★: Reprint requests: Elise A. Olsen, MD, Box 3294, Duke University Medical Center, Durham, NC 27710.

View full text

ReportsA randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men☆,☆☆,★,★★

Abstract

Section snippets

Patient population

Baseline characteristics

Discussion

Acknowledgements

Dermatol Clin

J Am Acad Dermatol

Clin Dermatol

Androgenetic alopecia

Treatment of hair loss

N Engl J Med

Reports
A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men☆,☆☆,★,★★