Efficacy and safety of 5% minoxidil topical foam in male pattern hair loss treatment and patient satisfaction

Abstract

Introduction:
Male pattern hair loss is widespread around the world. Its prevalence indicates the importance of finding the best treatment modalities. This study evaluates the efficacy and safety of minoxidil 5% topical foam in male pattern hair loss treatment and patient satisfaction.

Methods:
This study was a before-and-after trial on 17 male patients with male pattern hair loss. Subjects were instructed to apply one capful (1 ml) of minoxidil 5% topical foam on the scalp daily for 6 months. Efficacy was assessed through hair counts, subject assessment, and global photographic review.

Results:
Seventeen male volunteers were recruited, and three volunteers were withdrawn; 14 participated in the trial for 16 weeks, and 12 continued up to 24 weeks. The average hair count with a camera at week 16 (181.87 ± 52.42) and week 24 (194.58 ± 62.82) and with an eye count at week 16 (62.57 ± 15.28) and week 24 (69.91 ± 15.61) increased significantly compared to the baseline after intervention.

Conclusions:
This study confirmed that minoxidil 5% topical foam is a safe and effective treatment for MPHL. The effect of it is evident after 24 weeks of use.

Full text

Ecacy and safety of 5% minoxidil topical foam in male pattern hair
loss treatment and patient satisfaction
Hournaz Hasanzadeh1, Saman Ahmad Nasrollahi1, Nader Halavati2, Maryam Saberi3 ✉, Alireza Firooz1,2
1Pharmaceutical, Cosmeceutical, and Hygienic Skin Products Clinical Evaluation Lab (DermaLab), Center for Research & Training in Skin Diseases &
Leprosy (CRTSDL), Tehran University of Medical Sciences (TUMS), Tehran, Iran. 2Clinical Trial Center (CTC); Tehran University of Medical Sciences (TUMS),
Tehran, Iran. 3Community-Based Participatory Research Center, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sci-
ences (TUMS), Tehran, Iran. ✉ Corresponding author: marsabery@yahoo.com, saberinamin@razi.tums.ac.ir
41
2016;25:41-44
doi: 10.15570/actaapa.2016.12
Background
Male pattern hair loss (MPHL), or androgenic alopecia, is the most
prevalent type of hair loss in men. It aects 30 to 50% of men by
age 50 (1). The prevalence of hair loss type III or greater in men 18
to 49 years old has been estimated to be at least 42%. Within the
age range of 40 to 49 years, 53% of men have moderate to exten-
sive hair loss (2).
MPHL is oen regarded as a relatively minor medical condi-
tion, but it may result in anxiety and depression in some men
because it impacts self-image (1). MPHL caused low self-esteem,
depression, and dissatisfaction with body appearance in a multi-
national study. The result of the study showed that 96% of men
in the United States, France, Germany, Spain, Japan, and Korea
25 to 49 years old reported concerns about their hair loss, and
75% mentioned they were extremely concerned. Only 16% of men
reported they had not attempted any treatment, whereas 34% of
men had tried one or two treatments before the study, 24% tried
three or four, and 26% tried ve or more self-treatments. A total of
24.4% of men in this study said that they were dissatised with
their physician consultations, and most of them indicated that
their dissatisfaction was a result of a specic treatment recom-
mendation, remaining unanswered questions, or physician dis-
comfort or disinterest in discussing hair loss (3).
Most treatment modalities for MPHL are not FDA-approved
and overall are not signicantly eective. Minoxidil 5% topical
solution (MTS) is FDA-approved for men with MPHL. Substituting
for MTS, a foam vehicle has been developed to deliver minoxidil.
Consumer use studies have shown that the foam formula was rat-
ed signicantly higher on several aesthetic attributes compared
to MTS (4–6).
Our study assessed the ecacy and safety of a 5% minoxidil
topical formulation in a propylene glycol–free foam vehicle in
men with androgenic alopecia.
Patients and methods
Design: A phase 2 before-and-aer trial was carried out on 17 pa-
tients with MPHL for 6 months at the Pharmaceutical, Cosmeceu-
tical, and Hygienic Evaluation Lab (Derma Lab) of the Center for
Research & Training in Skin Diseases & Leprosy, Tehran Univer-
sity of Medical Sciences (TUMS) in Tehran, Iran. Inclusion criteria
were men with MPHL between 18 and 49 years old, Hamilton–
Norwood pattern III–V, with normal health status, and providing
written informed consent. Exclusion criteria were sensitivity to
minoxidil, using any topical OTC or prescription medication for
hair growth within the past 3 months, using 5α-reductase inhibi-
tors within the past year, using isotretinoin within the past year,
radiation to the scalp within the past year, chemotherapy within
the past year, using botanicals/nutraceuticals for hair regrowth
for the past 3 months, using systemic steroids for more than 14
days within the past 2 months prior to enrollment in the study,
uncontrolled hypertension, history of hypotension, any chronic
active scalp inammation or infection, any untreated cancer ex-
cluding basal cell carcinoma and squamous cell carcinoma of
non-scalp areas, scalp reduction, and use of hair weaves.
The subjects were instructed to apply one capful (1 ml) of mi-
noxidil 5% topical foam (Delta Darou, Iran) to the scalp and then
massage it into the vertex and frontal balding scalp once a day
and not wash it for at least 6 hours.
Ecacy assessment: The following assessments were made at
baseline and at 16 and 24 weeks aer treatment:
Abstract
Introduction: Male pattern hair loss is widespread around the world. Its prevalence indicates the importance of nding the best
treatment modalities. This study evaluates the ecacy and safety of minoxidil 5% topical foam in male pattern hair loss treatment
and patient satisfaction.
Methods: This study was a before-and-aer trial on 17 male patients with male pattern hair loss. Subjects were instructed to apply
one capful (1 ml) of minoxidil 5% topical foam on the scalp daily for 6 months. Ecacy was assessed through hair counts, subject
assessment, and global photographic review.
Results: Seventeen male volunteers were recruited, and three volunteers were withdrawn; 14 participated in the trial for 16 weeks,
and 12 continued up to 24 weeks. The average hair count with a camera at week 16 (181.87 ± 52.42) and week 24 (194.58 ± 62.82)
and with an eye count at week 16 (62.57 ± 15.28) and week 24 (69.91 ± 15.61) increased signicantly compared to the baseline aer
intervention.
Conclusion: This study conrmed that minoxidil 5% topical foam is a safe and eective treatment for MPHL. The eect of it is evi-
dent aer 24 weeks of use.
Keywords: minoxidil, foam, hair loss, alopecia
Acta Dermatovenerologica
Alpina, Pannonica et Adriatica
Acta Dermatovenerol APA
Received: 20 July 2016 | Returned for modication: 25 July 2016 | Accepted: 5 August 2016

42
Acta Dermatovenerol APA | 2016;25:41-44H. Hasanzadeh et al.
1) Target area hair counts:
A) A semi-permanent ink-dot tattoo was placed for precise lo-
calization of the target area.
B) A camera was used to take photographs of the target area
and the entire scalp in precisely xed situations.
C) All visible hairs were dot-mapped and counted by a techni-
cian trained in the procedure and blinded to the intervention.
2) Subject assessment:
Subjects were asked to ll out a questionnaire that rated their
overall hair-loss condition in the vertex region compared to
baseline. They rated their perception of their hair-loss con-
dition compared to the baseline using a ve-point scale, on
which −2 = moderately worse, −1 = minimally worse, 0 = no
change, +1 = minimally improved, +2 = moderately improved.
3) Global photographic review (GPR):
GPR was carried out at baseline and at 6 months aer treat-
ment. The baseline and post-treatment pictures were shown in
a side-by-side presentation and were rated independently by a
blinded dermatologist using the same ve-point scale as above.
Safety assessment: The patients were asked and examined for
possible side eects, including signs of scalp irritation such as
dryness/scaling, folliculitis, and erythema.
Data collection and analysis: A specic case report form was
prepared and completed for each patient to collect data. Percent-
age and frequency were used to describe qualitative data, and
mean and standard deviation were used for description of quanti-
tative data. The comparison of quantitative data before and aer
the test was performed by non-parametric equivalent. Estimation
of all the tests was performed at a signicance level of 5%.
Ethics: All patients signed an informed consent form prior to
inclusion. The Ethics Committee approved the project and the
Declaration of Helsinki was followed throughout the study.
Results
Seventeen volunteers were enrolled in this study. One of them was
excluded due to irregular use of the drug despite satisfaction with
the treatment. Another one le the study due to lack of satisfaction
with the drug. One patient reported desquamation and further hair
loss aer 2 months of use and was excluded. In the end, 14 patients
participated in the study for 16 weeks, and 12 continued up to 24
weeks. The mean (± SD) age of the participants was 30.35 (± 8.4),
range 18 to 44 years. The characteristics of the participants and
hair-loss features at the baseline are shown in Table 1.
Upon assessment of hair loss at weeks 16 and 24, 64.3% and
75.0% of the volunteers, respectively, conrmed that their hair-
loss condition had improved aer using the drug (Table 2).
As Table 3 shows, the average hair count with a camera at
week 16 (181.87 ± 52.42) and week 24 (194.58 ± 62.82), and with
an eye count at week 16 (62. 57 ±15.28) and week 24 (69.91 ±15.61)
increased signicantly compared to the baseline aer interven-
tion. Figure 1 conrms this improvement in the hair count for two
volunteers aer 24 weeks.
The global photographic review by an expert aer intervention
indicated that 21.4% showed no change, 28.6% showed minimal
improvement, and 50.0% showed moderate improvement (Ta-
ble 4 and Fig. 2). The satisfaction with ecacy (reduction in the
amount of hair loss, new hair growth, or increase in hair thick-
ness) at weeks 16 and 24 showed that 50.2% and 75.0% of the
participants were very satised, respectively. Regarding the drug
dosage form and ease of use at weeks 16 and 24, 85.7% and 91.6%
of the participants were very satised, respectively (Table 5).
Among the participants that regularly took the drug for at least
4 months, two people reported mild itching on the neck. No seri-
ous side eects were seen during the treatment.
Discussion
Androgenic alopecia is the prevalent cause of baldness occurring
through progressive hair loss (7). Because the prevalence rates are
so high in the Asian studies mentioned above, a more standard-
ized protocol is necessary. The dierent types of hair loss and fam-
ily histories of Asian patients with androgenic alopecia may aect
treatment response (8).
This study was conducted to evaluate the ecacy of minoxidil
5% topical foam in Iranian men.
The results showed that the average hair count (with camera
and eye) increased at weeks 16 and 24 compared to the baseline
with a signicant dierence (Table 3 and Fig. 1).
A study by Olsen et al. comparing 5% minoxidil foam with a
placebo in androgenic alopecia showed that the mean target
Table  | Characteristics of participants and hair-loss features at baseline.
Characteristic
Grade
n
Percent
Male pattern hair-loss
grade based on the
Hamilton–Norwood scale


.


.


.
Use of drug
Completely regular

.
Regular

.
Table  | Subject assessment of hair-loss condition at weeks  and .
Scale Week , N = 
n (%)
Week , N = 
n (%)
− Moderately worse


− Minimally worse


 No change
 (. )
 (.)
+ Minimally improved
 (.)
 (.)
+ Moderately improved
 (.)
 (.)
Table  | Week  and  changes from baseline hair count.
Variable
Before intervention
N = 
Mean (SD)
Aer intervention
week , N = 
Mean (SD)
p value
(weeks  and )
Aer intervention
week , N = 
Mean (SD)
p value
(weeks  and )
Target area hair count (camera)
. (.)
. (.)
.
. (.)
.
Target area hair count (eye)
.  (.)
. (.)
.
. (.)
.
Figure  | Two volunteers with moderate improvement in average hair growth at
week  (before, aer).

43
Acta Dermatovenerol APA | 2016;25:41-44 Minoxidil foam in male pattern hair loss treatment
area hair count increased signicantly compared to the baseline
(20.9% vs. 4.7%) (5).
In another study, Hillmann et al. reported that application of
minoxidil 5% topical foam improved the front temporal and ver-
tex target area hair count and width compared to the baseline up
to week 16. At 24 weeks, signicant improvement in scalp cover-
age for the target area was reported (9). A placebo control assess-
ment of minoxidil 5% topical foam in hair density, width, and
scalp coverage in the vertex and front temporal areas showed that
minoxidil 5% topical foam is eective in the target area of men in
104 weeks (10).
In our study, an expert panel review of global photographic as-
sessment, which is a useful follow-up tool and a way to assess
treatment response, showed a 78.6% improvement in treatment
response (Fig. 2). This outcome conrms the result by Mirmirani
et al. Their study of 16 men demonstrated that minoxidil topical
foam induced hair growth on the vertex and frontal scalp of pa-
tients with androgenic alopecia (11). Further studies on the e-
cacy of minoxidil 5% topical foam for treating female pattern hair
loss have shown that this kind of formulation can be attractive
(12, 13).
All of the studies above mentioned greater eectiveness of
minoxidil 5% topical foam in improving hair growth in men and
woman. However, some studies compared minoxidil topical foam
and minoxidil topical solution. Preclinical studies comparing the
ecacy of 5% foam versus 5% solution vehicles on hamster ears
showed a greater uptake of minoxidil 5% topical foam (14). An-
other study, in which six macaques were treated topically with
the two formulations above, demonstrated increased hair weight
of 12.4 mg with minoxidil 5% topical foam versus 9.27 mg with
minoxidil 5% topical solution from the baseline (15). More studies
are needed on the eects on hair growth with minoxidil 5% topi-
cal foam versus minoxidil 5% topical solution.
Assessment of the condition of volunteers at weeks 16 and 24
revealed that hair loss aer using the 5% minoxidil topical foam
improved (64.3% and 75.0% improvement, respectively). This
outcome is similar to the results reported by Olsen et al., which
showed that 70.6% of participants stated that their hair loss had
improved from the baseline and only 6.2% were not satised (5).
Our results showed that the participants were satised with the
drug ecacy at week 16 (50.2%) and week 24 (75.0%) and with the
drug form and ease of use at week 16 (85.7%) and week 24 (91.6%).
This is comparable to a consumer use study that reported similar
satisfaction regarding application such as lack of dripping and
quick absorption and drying (5, 16).
None of the participants experienced any skin burning, itch-
ing, erythema, swelling, or scaling aer applying minoxidil 5%
topical foam. Adverse eects aer the use of minoxidil 2% topi-
cal solution on the scalp (such as itching, dryness, and redness)
were observed in 7% of patients. These complications are higher
aer the use of minoxidil 5% topical solution because the con-
centration of propylene glycol is a key factor in the sensitivity of
irritated skin and is known as a factor in allergic contact derma-
titis. Because the foam is free of propylene glycol, the side eects
are therefore less than with the solution (16). Our research results
showed that the tolerability prole was high and the low rate of
irritant contact dermatitis was the same as in the results reported
in the study by Kanti et al. (10).
Conclusion
Androgenic alopecia is one of the most prevalent dermatological
illnesses that causes patients to seek treatment. There are limited
options for treating it eectively. This is why androgenic alope-
cia remains an important area for further research to obtain more
information regarding its pathogenesis and newer therapeutic
options that are now being developed. Our study indicates that
minoxidil 5% topical solution is a safe and eective treatment for
MPHL and increasing hair count.
Acknowledgement
We thank Delta Darou for material support and the patients in the
study. We are also grateful for the cooperation of Somayeh Yadan-
gi. This project was funded by Center for Research & Training in
Skin Diseases & Leprosy of Tehran University of Medical Sciences
under project no G- 423-251.
Table  | Global photographic review aer intervention.
Scale
Results, N = 
n
%
− Moderately worse


− Minimally worse


 No change

.
+ Minimally improved

.
+ Moderately improved

.
Table  | VAS score of drug eect, form, and ease of use at weeks  and .
VAS scores
Drug eect
Dosage form and ease of use
Week 
N = 
n (%)
Week 
N = 
n (%)
Week 
N = 
n (%)
Week 
N = 
n (%)
–.
 (.)



.–
 (.)
 (.)
 (.)
 (.)
–.
 (.)
 (.)
 (.)
 (.)
.–
 (.)
 (.)
(.)
 (.)
Figure  | A subject,  years old, with moderate improvement in hair growth as
rated by an expert panel at week  (before, aer).

44
Acta Dermatovenerol APA | 2016;25:41-44H. Hasanzadeh et al.
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