At the end of 1 year:
- The dermatologist investigators reported
that hair loss areas of the scalp had become smaller in 62% of the
patients, unchanged in 35.1% and larger in 2.9%.
- In evaluating minoxidil effectiveness in
stimulating hair regrowth, the investigators found the 5% solution
very effective in 15.9% of patients, effective in 47.8%, moderately
effective in 20.6% and ineffective in 15.7%.
- Hairs lost during washing numbered a
mean 69.7 at the beginning of the study, and a mean 33.8 at the end of
the study-a measure of the effectiveness of 5% minoxidil in halting
hair loss in the patients studied.
- The mean score of patient satisfaction
on a scale of 0 (extremely dissatisfied) to 10 (very satisfied)
increased from 2.9 at study beginning to 4.4 at study end. Patient
satisfaction scores were lower than the estimates of the physician
investigators: the investigators rated efficacy of treatment as good
or very good 25% more often than did the patients.
- Side effects, mostly dermatologic, were
reported by 3.9% of patients in the study. None of the side effects
was classified as serious.
A 4-month surveillance study involving 743
men with male-pattern hair loss was designed to evaluate (1) how quickly
men using 1 ml of 5% minoxidil solution twice a day began to notice
reduced hair loss and/or new hair growth, (2) efficacy of 5% minoxidil
solution in improving hair density in areas affected by male-pattern hair
loss, and (3) side effects associated with use of 5% minoxidil solution.
All results were evaluated and reported by
the men involved in the study; 150 physicians with male-pattern hair loss
were among the 743 patients studied.
At the end of 4 months:
- The scalp area affected by male-pattern
hair loss (the "balding" area) was judged smaller by 67.3%
of the men, unchanged by 31.9% and larger by 0.8%.
- The 5% minoxidil solution was judged
very effective in stimulating new hair growth by 7.5% of the men,
effective by 55%, moderately effective by 31.3% and ineffective by
- Hair density (the "fullness"
of scalp hair) was judged improved by 74.2% of the men, unchanged by
24.3% and worsened by 1.5%.
- Of the 669 men who reported when results
of minoxidil treatment were first noticeable, 13.9% reported results
in the first month, 52.3% during the second month, and 33.8% during
the third month.
- Skin-related side effects were reported
by 13 patients.
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
of minoxidil. 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 of reasons 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 finasteride (Propecia®), 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
Topical minoxidil is much more effective at
treating baldness that occurs on the top, or crown, of the head than it is
at causing hair growth on other parts of the head. Minoxidil does not work
for everyone and there is no predictor, in early 2001, of whether or not
it will be effective in any particular person. Clinical tests on the
effectiveness of topical minoxidil in men with baldness on the top of the
head showed that 48% of men who had used minoxidil for one year reported
moderate to dense re-growth of hair within the treated area. Thirty-six
percent reported minimal re-growth. While 16% reported no re-growth.
Similar percentages have been reported in women.
In both men and women, hair re-growth
generally does not begin until the medicine has been used for at least
four months. The first signs that minoxidil may be effective in a
particular person usually occur after approximately 90 days of treatment,
when the patient notices that he or she is losing (shedding) much less
hair than prior to beginning treatment.
When new growth begins, the first hairs may
be soft and barely visible. For some patients, this is the extent to the
effectiveness of this medication. For others, this down-like hair develops
into hair of the same color and thickness as the other hairs on their
Minoxidil is a treatment for hair loss, it
is not a cure. Once a patient stops taking minoxidil, he or she will most
likely lose all of the re-grown hair within 90 days of stopping the
medication and no further hair growth will occur.
HAIR LOSS STUDY
LONG-TERM EFFICACY OF TOPICAL MINOXIDIL IN MALE
Long-term efficacy of topical minoxidil in male pattern baldness.
Author: Katz HI, Hien NT, Prawer SE,
Source: J Am Acad Dermatol, 16: 3 Pt
2, 1987 Mar, 711-
A 24-month clinical trial, begun on a double-blind basis, was conducted in
153 men with discernible male pattern baldness of the crown with the use
of either topically applied placebo, 2% minoxidil, or 3% minoxidil
solution. After 4 months the patients using placebo were switched to 3%
minoxidil solution. At 12 months, there were statistically significant
increases in terminal hair growth within a 1-inch target area in those
treated with 2% or 3% minoxidil solution, in comparison with baseline
counts. However, there were few patients who had appreciable cosmetic
restoration. At 12- and 24-month intervals, progressive regression or
stabilization of the size of the bald area was noted in the majority of
patients. This therapeutic or preventive effect was statistically
significant. The data on actual target area hair counts suggested that the
2% minoxidil solution was equal to or more efficacious than the 3%
minoxidil solution. Baseline vital signs and laboratory parameters
remained essentially unchanged. Topical minoxidil was well tolerated, with
no serious drug-related adverse reactions noted during the study.
HAIR LOSS STUDY
TOPICAL MINOXIDIL THERAPY FOR ANDROGENIC ALOPECIA
IN THE MIDDLE EAST.
THE MIDDLE-EASTERN TOPICAL MINOXIDIL STUDY GROUP.
Topical minoxidil therapy for androgenic alopecia in the Middle East. The
Middle-Eastern Topical Minoxidil Study Group.
Author: Karam P Address: American University Hospital of
Beirut, New York, NY 10022.
Source: Int J Dermatol, 32: 10, 1993
BACKGROUND. A 48-week open label trial was conducted in five
Middle-Eastern countries (Lebanon, Egypt, Saudi Arabia, Jordan, and the
United Arab Emirates) to determine the safety and efficacy of 2% minoxidil
in the treatment of early androgenic alopecia and to compare the response
with Western countries. METHODS. One hundred and ninety-five men aged
between 19 and 47 years were enrolled. The duration of their baldness
varied from 6 months to 10 years, and they all showed a type III vertex or
type IV of the modified Hamilton scale. Baldness pattern, diameter of the
balding area, hair counting within a 2.5 cm bald patch as well as
investigator's and patient's evaluation were regularly noted. RESULTS. No
significant changes were observed in vital signs or laboratory parameters.
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.
HAIR LOSS STUDY
AUSTRALIAN TRIAL OF TOPICAL MINOXIDIL AND PLACEBO
IN EARLY MALE PATTERN BALDNESS.
Australian trial of topical minoxidil and placebo in early male pattern
Author: Connors TJ, Cooke DE, De
Launey WE, Downie M, Knudsen RG, Shumack S, Eggleston AS Address:
Monash Medical Centre Clayton, Vic.
Source: Australas J Dermatol, 31: 1,
One hundred and sixty nine men with early male pattern baldness
(androgenic alopecia) were treated in a random, double-blind fashion with
either 2% minoxidil solution or placebo vehicle for 24 weeks, one ml
applied twice daily. After 24 weeks all patients received the active
solution until week 48. After 24 weeks the minoxidil treated patients had
increased their non-vellus hair counts significantly more than the placebo
treated group; means were 37.6 and 8.8 hairs per reference area, 95% C.I.
for difference = 10.85 to 60.75. The rate of non-vellus hair regrowth was
also greater among minoxidil treated patients than placebo treated
patients. 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. None had dense growth. No serious adverse reactions or
deaths were reported. Minoxidil solution appeared to be an efficacious and
safe treatment for early androgenic alopecia.
HAIR LOSS STUDY
TREATMENT OF ANDROGENIC ALOPECIA WITH TOPICAL
Treatment of androgenic alopecia with topical minoxidil
Author: Brenner S, Tamir A
Address: Dermatology Dept., Sourasky
Medical Center, Tel Aviv.
Source: Harefuah, 121: 9, 1991 Nov 1,
Minoxidil, a vasodilator, was first marketed in 1979 as an oral
antihypertensive. Since hypertrichosis occurred as an adverse effect in
most patients treated, a 2% topical solution was developed for use in men
with androgenic alopecia. It was approved by the American Food and Drug
Administration and by the Israel Ministry of Health. A follow-up of 30
cases treated with the preparation is presented. Efficacy of treatment was
assessed by hair counts in a marked area on the balding scalp, as well as
by subjective evaluations of patients and physicians. The treatment was
beneficial in 63%: balding was slowed in most, while in a minority hair
density actually increased. However, in only 6.6% was dramatic cosmetic
HAIR LOSS STUDY
A CRITICAL REVIEW OF THE RESULTS OF CLINICAL
WITH TOPICAL MINOXIDIL 2%.
A critical review of the results of clinical experimentation with topical
Original Title: Revisione critica di alcuni risultati della
sperimentazione clinica con minoxidil topico al 2%.
D'Ovidio R, Di Prima T, De Pasquale R, D'Ovidio F
Address: Istituto Semeiotica
Chirurgica, Universitŕ di Bari.
Source: G Ital Dermatol Venereol, 125:
4, 1990 Apr, V-IX
The results of clinical double-blind trials using minoxidil 2% demonstrate
the real efficacy of the drug in producing satisfactory esthetical results
in some 30% of treated patients. One aspect of the results of this
research which is not yet clear is the significant increase in the number
of hairs, also found in voluntary subjects treated with placebo. In the
present study is hypothesised that this increase may be partially
explained by the failure to take into account the physiological seasonal
variations in hair density, and by the confusion caused by the use of the
"non-vello" category which is used to describe terminal (thick)
and indeterminate (thin) hairs. In our study placebo failed to produce a
significant increase in the number of terminal hairs, thus explaining why,
even in the presence of an increased number of "non-vello"
hairs, on average there was no real cosmetic benefit in these subjects.
HAIR LOSS STUDY
ENHANCED IN VITRO HAIR GROWTH AT THE AIR-LIQUID
INTERFACE: MINOXIDIL PRESERVES THE ROOT SHEATH IN CULTURED WHISKER
Enhanced in vitro hair growth at the air-liquid interface:
minoxidil preserves the root sheath in cultured whisker follicles.
Author: Waldon DJ, Kawabe TT, Baker
CA, Johnson GA, Buhl AE
Address: Upjohn Laboratories,
Department of Dermatology Research, Kalamazoo, Michigan 49001. Source:
In Vitro Cell Dev Biol Anim, 29A: 7, 1993 Jul, 555-61
Inasmuch as hair follicles are difficult to maintain in culture, the study
of hair biology using cultured hair follicles has met with only limited
success. In our attempts to solve the problem of follicle degeneration, we
cultured follicles at the air-surface interface on a modified collagen
matrix (Gelfoam). In follicles cultured at the air-surface or submerged,
we examined follicular morphology, hair shaft growth, sulfotransferase
levels, cysteine incorporation, an expression of a tissue inhibitor of
metalloproteinase (TIMP), and ultra-high sulfur keratin (UHSK). Follicles
cultured at the air-liquid interface produced a 2.7-fold increase in hair
growth and maintained an anagen-like morphology. Substrates such as nylon
mesh seeded with fibroblasts, Full Thickness Skin, or 5-microns
polycarbonate filter also supported hair growth, whereas Gelfilm, GF-A
glass filter, filter paper, or 1-micron polycarbonate filter did not. The
UHSK expression was significantly higher in the air-liquid interface
cultures compared to the submerged culture. Several potassium channel
openers, including minoxidil, a minoxidil analog, and the pinacidil analog
(P-1075), all stimulated significant cysteine incorporation in follicles.
Minoxidil and its analog specifically preserved the follicular root
sheath, in contrast to P-1075 which did not, indicating a difference in
the two drug types. The preservation of the root sheath was measured by
increased TIMP expression and sulfotransferase activity and indicates that
the root sheath is a target tissue for minoxidil. Our results show that
follicles cultured at the air-liquid interface maintain a better
morphology and produced greater hair growth than follicles cultured on
tissue culture plastic.
Minoxidil was the first drug approved by
the FDA for the treatment of androgenetic alopecia (hair loss). Before
that, minoxidil had been used as vasodilator drug prescribed as oral
tablet to treat high blood pressure, with side effects that included hair
growth and reversal of male baldness. In the 1980s, UpJohn Corporation
came out with a topical solution of 2% minoxidil, called Rogaine, for the
specific treatment of androgenetic alopecia. Since the 1990s, numerous
generic forms of minoxidil have become available to treat hair loss while
the oral form is still used to treat high blood pressure.
The popularity hair loss treatment is due
to the general preference in the overall population for the cosmetic
appearance of a full head of hair. Minoxidil is used to stimulate hair
growth in areas of the scalp that have stopped growing hair. As of early
2001, the exact mechanism of action of minoxidil is not known.
People who have had a prior unusual or
allergic reaction to either minoxidil or propylene glycol, a non-active
chemical in the Rogaine solution, should not use topical minoxidil. People
who have had a previous allergic reaction to preservatives or dyes may
also be at risk for having an allergic reaction to minoxidil.
People who are using cortisone, or
cortisone-like drugs (corticosteroids), petroleum jelly (Vaseline), or
tretinoin (Retin-A) on their scalps should consult their doctors prior to
using minoxidil. The use of any of these products in conjunction with
minoxidil may cause excessive minoxidil absorption into the body and
increase the risk of side effects.
Also, people who have skin problems or
irritations of the scalp, including sunburn, may absorb too much minoxidil
and increase their risk of side effects. As for oral minoxidil, the form
prescribed for high blood pressure, patients should use minoxidil only
under medical supervision to ensure that excessive amounts of the drug are
not absorbed into their bodies. Large amounts of minoxidil may increase
the severity of the symptoms and side effects of hypertension.
Minoxidil may pass from mother to child
through breast milk. Therefore, women who are breastfeeding should not use
For the treatment of hair loss, minoxidil
is available as a topical solution that is generally either 2% or 5%
minoxidil in propylene glycol. The propylene glycol ensures that the
applied minoxidil is evenly spread across the affected area and easily
absorbed through the skin. As of early 2001, the 5% solution is only
approved by the FDA for use on men. Approximately 1 milliliter of
minoxidil solution is applied to the scalp once a day using the fingertips
or a pump spray. It should be applied from the center of the area being
In the treatment of high blood pressure,
oral minoxidil is usually prescribed when other medications have failed to
treat the condition. Dosage is usually 2.5-100 mg per day as a single dose
for adults and 200 micrograms to 1 mg per kg of body weight for children.
The most common side effects of topical
minoxidil use are itching and skin irritation of the treated area of the
scalp. Unwanted hair growth may also occur adjacent to treated areas or in
areas where the medicine has been inadvertently transferred several times.
This unwanted hair growth adjacent to the treatment area may be
particularly distressing to women when the face is involved. The itching
and irritation usually subside after the drug has been used for
approximately two weeks. If symptoms persist after this time, minoxidil
use should be halted until a physician has been consulted.
Extremely rare side effects that may occur
if too much topically or orally administered minoxidil is being absorbed
in the body include:
- Changes in vision, most commonly blurred
- Chest pain;
- Very low blood pressure;
- Decreased sexual desire;
- Fast or irregular heartbeat;
- Flushing of the skin;
- Numbness or tingling in the hands, feet,
- Partial, or complete, impotence;
- Rapid weight gain;
- Swelling of the hands, feet, lower legs,